Supplementary Appendix

This appendix has been provided by the authors to give readers additional information about their work.

Supplement to: Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with
type 2 diabetes. N Engl J Med 2016;375:1834-44. DOI: 10.1056/NEJMoa1607141
SUSTAIN 6 – Summary of figures / tables included in the supplement

Table of Contents

Supplementary Appendix Page

SUSTAIN 6 Committee Members and Investigators 3

Additional statistical details 26

Figure S1A. Patient disposition 35

Figure S1B. Reasons for patients being excluded or leaving trial before 36
randomization

Figure S2. Forest plot showing sensitivity analyses for the primary 39
outcome

Figure S3. Forest plot showing subgroup analyses for the primary outcome 41

Figure S4. Cardiovascular outcomes by individual treatment group 43

Figure S5. Microvascular outcomes 47

Figure S6. Mean change in systolic (Panel A) and diastolic (Panel B) blood 49
pressure over time

Figure S7. Mean change in lipase (Panel A) and amylase (Panel B) over 51
time

Figure S8. Neoplasms: Total and malignant by organ of origin 54

Table S1. Eligible patients: Criteria for clinical and subclinical 55

cardiovascular disease

Table S2. List of inclusion and exclusion criteria 57

Table S3. Glycemic control in SUSTAIN 6 60

 Actions taken to ensure optimal glycemic control in
SUSTAIN 6

Table S4. Clinical event definitions for all adjudicated outcomes 62

Table S5. Premature treatment discontinuation 78

Table S6. Baseline characteristics (expanded) 80

Table S7A. Antihyperglycemic medication at baseline 85

Table S7B. Introduction of antihyperglycemic medication during the trial 87

Table S8A. Cardiovascular medication at baseline 89

Table S8B. Introduction of cardiovascular medication during the trial 92

1 
 
 Table S9. Primary and secondary cardiovascular and microvascular 96
outcomes (expanded)

Table S10. Change from baseline at Week 104 for glycated hemoglobin, 101
body weight, blood pressure and pulse, and ratio to baseline at
Week 104 for lipids

Table S11. Serious adverse events by system organ class 105

 

   

2 
 
SUSTAIN 6 Committee Members and Investigators

Data Monitoring Committee:

Chair: David Fitchett, St Michael’s Hospital, Toronto, Canada

Judith D. Bebchuk, Kaiser Permanente, Pasadena, CA, USA; Nicholas Boon, Royal Infirmary
of Edinburgh, Edinburgh, UK; David Fitchett, St Michael’s Hospital, Toronto, Canada;
Timothy Gardner, Dartmouth-Hitchcock Medical Center, Lebanon, PA, USA; Silvio Inzucchi,
Yale University School of Medicine, USA, New Haven, CT, USA

Event Adjudication Committees

Chair: Bernard R. Chaitman, Saint Louis University Core ECG Laboratory, St. Louis, USA

Cardiology: Richard Bach, Washington University School of Medicine, St. Louis, MO, USA;
Bernard R. Chaitman, Saint Louis University Core ECG Laboratory, St. Louis, MO, USA;
Gilbert Gosselin, Montreal Heart Institute, Montreal, Canada; Abhay A. Laddu, Saint Louis
University School of Medicine, St. Louis, USA

Endocrinology: Stewart G. Albert, Saint Louis University School of Medicine, St. Louis, MO,
USA

Gastroenterology: C. Prakash Gyawali Washington University School of Medicine, St.

Louis, MO, USA; Daniel Kast Mullady, Washington University School of Medicine, St. Louis,
MO, USA

Nephrology: Geoffrey Block, University of Colorado Health Sciences Center, Denver, CO,
USA; David Bushinsky, University of Rochester Medical Center, Rochester, NY, USA; Kevin
Martin, Saint Louis University School of Medicine, St. Louis, MO, USA

Neurology: Amer Alsheklhee, Saint Louis University School of Medicine, St. Louis, MO,
USA; Salvador Cruz-Flores, Texas Tech University Health Sciences Center at El Paso, El
Paso, TX, USA; Eli S. Feen, Saint Louis University School of Medicine, St. Louis, MO, USA

Oncology: Meagan A. Jacoby, Washington University School of Medicine, St. Louis, MO,
USA; Joel Picus, Washington University School of Medicine, St. Louis, MO, USA; Mark A.
Schroeder, Washington University School of Medicine, St. Louis, MO, USA

Ophthalmology: Levent Akduman, Saint Louis University, St. Louis, MO, USA; B. Wayne
Dudney, Retina Associates of St. Louis, Florissant, MO, USA

3 
 
Study Investigators

Algeria: Kahina Aberkane, Salah Mansour, Tizi Ouzou; Malika Bachaoui, 1st November 1954
Hospital, Oran; Leila Nadia Benali, 1st November 1954 Hospital, Oran; Abdelaziz Berra,
CHU de Setif, Setif; Yachar Bouacha, Ibn Sina Hospital, Annaba; Nadia Bouziani, 1st
November 1954 Hospital, Oran; Takait Essalem Charef, CHU de Setif, Setif; Saadia Dahliz,
Salah Mansour, Tizi Ouzou; Malika Far, Ibn Siba Hospital, Annaba; Samia Griene, Ibn Siba
Hospital, Annaba; Mahdi Guessas, CHU de Setif, Setif; Nour El Houda Guettaf, CHU de Setif,
Setif; Fatma Zohra Hachelaf, Ibn Sina Hospital, Annaba; Souad Ibtissam Hannane, 1st
November 1954 Hospital, Oran; Zohra Lakabi, Salah Mansour, Tizi Ouzou; Abdellah Salah
Mansour, Salah Mansour, Tizi Ouzou; Hayet Merabet, Salah Mansour, Tizi Ouzou; Amel
Moussaoui, Ibn Sina Hospital, Annaba; Abdelmalek Nechadi, CHU de Setif, Setif; Said
Ouardane, Salah Mansour, Tizi Ouzou; Amine Rahou, 1st November 1954 Hospital, Oran.

Argentina: Guillermo Bianchi, Hospital Sirio Libanes, Ciudad Autonoma de Buenos Aires;
Gabriela Caeiro, Centro Diabetologico Cordoba Dr. Waitman, Cordoba; Martha Calveyra,
Medical Center of Diabetes and Nutrition, Ciudad Autonoma de Buenos Aires; Horacio
Cestari, Sanatorio Güemes, Ciudad Autonoma de Buenos Aires; Natalia Cluigt, Instituto de
Investigaciones Clinicas, Mar del Plata; Elisa Diaz, Sanatorio Güemes, Ciudad Autonoma de
Buenos Aires; Débora Ferrari, Hospital Sirio Libanes, Ciudad Autonoma de Buenos Aires;
Hernan Finkelstein, Sanatorio Güemes, Ciudad Autonoma de Buenos Aires; Gustavo
Frechtel, Hospital Sirio Libanes, Ciudad Autonoma de Buenos Aires; Graciela Galeano,
Consultorio Integral de Atención al Diabético, Morón; Laura Garate, Fundacion Favaloro,
Ciudad Autonoma de Buenos Aires; Veronica Geronazzo, Medical Center of Diabetes and
Nutrition, Ciudad Autonoma de Buenos Aires; G Gili, Consultorio Integral de Atención al
Diabético, Morón; Cecilia Heredia, Consultorio Integral de Atención al Diabético, Morón;
Sonia Hermida, Consultorio Integral de Atención al Diabético, Morón; Claudia Issa,
Sanatorio Güemes, Ciudad Autonoma de Buenos Aires; Stella Lapolla, Medical Center of
Diabetes and Nutrition, Ciudad Autonoma de Buenos Aires; Silvia Lovecchio, Hospital Sirio
Libanes, Ciudad Autonoma de Buenos Aires; María Lozano, Centro Diabetologico Cordoba
Dr. Waitman, Cordoba; Alfredo Marianacci, Consultorio Integral de Atención al Diabético,
Morón; Pablo Martinez, Instituto de Investigaciones Clinicas, Mar del Plata; Juan Moukarzel,
Fundacion Favaloro, Ciudad Autonoma de Buenos Aires; Clara Muller, Hospital Sirio Libanes,
Ciudad Autonoma de Buenos Aires; Constanza Olivera, Hospital Sirio Libanes, Ciudad
Autonoma de Buenos Aires; Alejandra Oviedo, Medical Center of Diabetes and Nutrition,
Ciudad Autonoma de Buenos Aires; Eduardo Parysow, Sanatorio Güemes, Ciudad Autonoma
de Buenos Aires; F Ponce, Sanatorio Güemes, Ciudad Autonoma de Buenos Aires; Jose
Pozzi, Centro Diabetologico Cordoba Dr. Waitman, Cordoba; Edgardo Ridner, Hospital Sirio
Libanes, Ciudad Autonoma de Buenos Aires; Hugo Sanabria, Fundacion Favaloro, Ciudad
Autonoma de Buenos Aires; Virginia Sernia, Instituto de Investigaciones Clinicas, Mar del
Plata; Silvana Solis, Centro Diabetologico Cordoba Dr. Waitman, Cordoba; Georgina
Sposetti, Instituto de Investigaciones Clinicas, Mar del Plata; Patricia Varela, Instituto de
Investigaciones Clinicas, Mar del Plata; Virginia Visco, Consultorio Integral de Atención al

4 
 
Diabético, Morón; Virginia Visco, Medical Center of Diabetes and Nutrition, Ciudad
Autonoma de Buenos Aires; Jorge Waitman, Centro Diabetologico Cordoba Dr. Waitman,
Cordoba; Silvana Yohena, Hospital Sirio Libanes, Ciudad Autonoma de Buenos Aires.

Australia: Jenny Bennett, Box Hill Specialist Consulting rooms, Box Hill, VIC; Tim Davis,
Fremantle Hospital, Fremantle, WA; Su Ann Ding, Blacktown Hospital, Blacktown, NSW;
Gregory Fulcher, Royal North Shore Hospital, St Leonards, NSW; Christopher Gilfillan, Box
Hill Specialist Consulting rooms, Box Hill, VIC; Jui Ho, SAn Endocrine Research, Keswick,
SA; Samantha Hocking, Royal North Shore Hospital, St Leonards, NSW; Sue-Lynn Lau,
Blacktown Hospital, Blacktown, NSW; Melissa Lee, St Vincent's Hospital, Fitzroy, VIC; Jaime
Lin, Blacktown Hospital, Blacktown, NSW; Katherine Lynch, Ipswich Hospital, Ipswich, QLD;
Richard MacIsaac, St Vincent's Hospital, Fitzroy, VIC; Ashley Makepeace, Fremantle
Hospital, Fremantle, WA; Mark McLean, Blacktown Hospital, Blacktown, NSW; Negar
Naderpoor, Repatriation General Hospital, Daw Park, SA; Thomas Nathow, Ipswich Hospital,
Ipswich, QLD; Anjana Radhakutty, Repatriation General Hospital, Daw Park, SA; Evelyn
Rank, Ipswich Hospital, Ipswich, QLD; Kannan Reddy, Blacktown Hospital, Blacktown, NSW;
Anthony Roberts, SAn Endocrine Research, Keswick, SA; Nirupa Sachithanandan, St
Vincent's Hospital, Fitzroy, VIC; Richard Simpson, Box Hill Specialist Consulting rooms, Box
Hill, VIC; Stephen Stranks, Repatriation General Hospital, Daw Park, SA; Jessie Teng, St
Vincent's Hospital, Fitzroy, VIC; Glenn Ward, St Vincent's Hospital, Fitzroy, VIC; Jane
Zhang, Blacktown Hospital, Blacktown, NSW.

Brazil: Gustavo Akerman, CPQuali Pesquisa Clínica Ltda, São Paulo, SP; Erica Alves, Centro
de Pesquisas Clínicas, São Paulo, SP; Breno Alves, Disciplina de Endocrinologia, Hospital das
Clínicas de São Paulo, São Paulo, SP; Jacy Alves, Hospital de Clínicas da Universidade
Federal do Paraná, Curitiba, PR; Pierro Berlinger, Pontifical Catholic University of Campinas,
Hospital e Maternidade Ceiso, Campinas, SP; Anke de Bem, Hospital de Clínicas da
Universidade Federal do Paraná, Curitiba PR; Renata Bona, Centro de Pesquisas Clínicas,
São Paulo, SP, Luis Canani, Centro de Pesquisas em Diabetes Ltda, Porto Alegre, RS; Ana
Carolina, Hospital Universitário João de Barros Barreto, Universidade Federal do Pará,
Belém, PR; Denise Castro, Centro de Pesquisas Clínicas, São Paulo, SP; Cintia Cercato,
Disciplina de Endocrinologia, Hospital das Clínicas de São Paulo, São Paulo, SP; Cintia
Cercato, Disciplina de Endocrinologia, Hospital das Clínicas de São Paulo,São Paulo, SP;
Midiã Costa, Pontifical Catholic University of Campinas, Hospital e Maternidade Ceiso,
Campinas, SP; Freddy Eliaschewitz, Centro de Pesquisas Clínicas, São Paulo, SP; João
Felício, Hospital Universitário João de Barros Barreto, Universidade Federal do Pará, Belém,
PR; Denise Franco, Centro de Pesquisas Clínicas, São Paulo, SP; Paulo Genestreti, Centro de
Pesquisas Clínicas, São Paulo, SP; Rodrigo Gonçalves, Centro de Pesquisas Clínicas, São
Paulo, SP; Michele Grossman, Centro de Pesquisas Clínicas, São Paulo, SP; Jorge Gross,
Centro de Pesquisas em Diabetes Ltda., Porto Alegre, RS; Cláudia Guimarães, CPQuali
Pesquisa Clínica Ltda, São Paulo, SP; Thaisa Jonasson, Hospital de Clínicas da Universidade
Federal do Paraná, Curitiba, PR; Fernanda Justus, Hospital de Clínicas da Universidade
Federal do Paraná, Curitiba, PR; Suzanny Ladeira, Hospital Universitário João de Barros
Barreto, Universidade Federal do Pará, Belém, PR; Franciane Melo, Hospital Universitário

5 
 
João de Barros Barreto, Universidade Federal do Pará, Belém, PR; Karem Miléo, Hospital
Universitário João de Barros Barreto, Universidade Federal do Pará, Belém, PR; Margareth
Miyahara, Hospital Universitário João de Barros Barreto, Universidade Federal do Pará,
Belém, PR; Lidiane Perlamagna, Centro de Pesquisas Clínicas, São Paulo, SP; Rosangela
Rea, Hospital de Clínicas da Universidade Federal do Paraná, Curitiba, PR; Celia Regina,
Centro de Pesquisas Clínicas, São Paulo, SP; Sylka Rodovalho, Pontifical Catholic University
of Campinas, Hospital e Maternidade Ceiso, Campinas, SP; Augusto Santomauro, CPQuali
Pesquisa Clínica Ltda, São Paulo, SP; José Saraiva, Pontifical Catholic University of
Campinas, Hospital e Maternidade Ceiso, Campinas, SP; Carla Sartori, Centro de Pesquisas
em Diabetes Ltda, Porto Alegre, RS; Flávia Silvia, Pontifical Catholic University of Campinas,
Hospital e Maternidade Ceiso, Campinas, SP; Kátia Siqueira, Centro de Pesquisas Clínicas,
São Paulo, SP; Luiz Turatti, CPQuali Pesquisa Clínica Ltda, São Paulo, SP; Marcelo Uehara,
Centro de Diabetes e Obesidade, Hospital do Rim e Hipertensão, São Paulo, SP; Adriana
Valenti, Centro de Pesquisas em Diabetes Ltda, Porto Alegre, RS; Guilherme Visconti,
Centro de Pesquisas Clínicas, São Paulo, SP; Leila Zanatta, Hospital de Clínicas da
Universidade Federal do Paraná, Curitiba, PR; Maria Teresa Zanella, Centro de Diabetes e
Obesidade, Hospital do Rim e Hipertensão, São Paulo, SP.

Bulgaria: Zhivka Asyova, Medical Institute of Ministry of interior, Sofia; Mila Boyadzhieva,
MHAT Sveta Marina, Varna; Ivona Daskalova, MMA-MHAT Sofia, Clinic of Endocrinology and
Metabolic Diseases, Sofia; Silviya Ganeva-Todorova, UMHAT Dr. Georgi Stranski, Pleven;
Kiril Hristozov, MHAT Sveta Marina, Varna; Galina Kibarova, Medical Institute of Ministry of
interior, Sofia; Veselin Kokareshkov, UMHAT Dr. Georgi Stranski, Pleven; Galina Kolcheva,
Medical Institute of Ministry of interior, Sofia; Ivaylo Lefterov, DCC XII-Sofia EOOD,
Endocrinology Consulting Room, Sofia; Nadezhda Popova, Medical Institute of Ministry of
interior, Sofia; Katya Todorova, UMHAT Dr. Georgi Stranski, Pleven; Antoaneta Toneva,
UMHAT Dr. Georgi Stranski, Pleven; Tzvetelina Totomirova, MMA-MHAT Sofia, Clinic of
Endocrinology and Metabolic Diseases, Sofia; Boyana Trifonova, MHAT Sveta Marina, Varna;
Natalia Veleva, DCC XII-Sofia EOOD, Endocrinology Consulting Room, Sofia.

Canada: Andrew Advani, St. Michael's Hospital, Toronto, Ontario; Simona Burs, C-endo
Diabetes and Endocrinology Clinic, Calgary, Ontario; Sylvain Chouinard, Institut
Universitaire de Cardiologie et de Pneum. de Quebec, Quebec, Ontario; Mei Chu, C-endo
Diabetes and Endocrinology Clinic, Calgary, Ontario; James Conway, Canadian Centre for
Research on Diabetes, Smiths Falls, Quebec; Francois Dube, Institut Universitaire de
Cardiologie et de Pneum. de Quebec, Quebec, Quebec; Fadia El Boreky, Sameh Fikry
Medicine Professional Corporation, Waterloo, Manitoba; Sameh Fikry, Sameh Fikry Medicine
Professional Corporation, Waterloo, Manitoba; Claude Garceau, Institut Universitaire de
Cardiologie et de Pneum. de Quebec, Quebec, Ontario; Benoit Gervais, Rhodin Recherche
Clinique, Drummondville, Ontario; Mahua Ghosh, University of Alberta, Edmonton, Alberta;
Jean-Marc Girard, Medexa Recherche, Victoriaville, Alberta; Amir Hanna, St. Michael's
Hospital, Toronto, Alberta; Thomasz Hruczkowski, University of Alberta, Edmonton,Alberta;
Carmen Hurd, Winnipeg Regional Health Authority, Winnipeg, Alberta; Robert Josse, St.

6 
 
Michael's Hospital, Toronto, Alberta; Tisha Joy, St. Joseph's Health Care, London, Ontario;
Marcel Jutras, Rhodin Recherche Clinique, Drummondville, Ontario; Munish Khosla, C-endo
Diabetes and Endocrinology Clinic, Calgary, Quebec; Isabelle Kirouac, Institut Universitaire
de Cardiologie et de Pneum. de Quebec, Quebec, Quebec; Isabelle Labonte, Institut
Universitaire de Cardiologie et de Pneum. de Quebec, Quebec, Quebec; Lawrence A. Leiter,
St. Michael's Hospital, Toronto, Quebec; Stephanie Li, University of Alberta, Edmonton,
Quebec; Joanne Liutkus, Cambridge, Ontario; Irene M. Hramiak, St. Joseph's Health Care,
London, Ontario; Charlotte McDonald, St. Joseph's Health Care, London, Ontario; Alykhan
Nanji, C-endo Diabetes and Endocrinology Clinic, Calgary, Ontario; Raj Padwal, University of
Alberta, Edmonton, Ontario; Beata Patasi, Canadian Centre for Research on Diabetes Smiths
Falls, Quebec; Terri Paul, St. Joseph's Health Care, London, Quebec; Sue Pedersen, C-endo
Diabetes and Endocrinology Clinic, Calgary, Alberta; Kathleen Raby, Institut Universitaire de
Cardiologie et de Pneum. de Quebec, Quebec, Alberta; Alan Rosenbloom, Scisco Clinical
Research, Cornwall, Alberta; Lorne Scharf, Scisco Clinical Research, Cornwall, Alberta; Peter
Senior, University of Alberta, Edmonton, Alberta; Roya Shaikholeslami, Cambridge, Ontario;
Chandrasekaran Sivakumar, C-endo Diabetes and Endocrinology Clinic, Calgary, Ontario;
Anca Tapardel, University of Alberta, Edmonton, Ontario; Guy Theriault, Medexa Recherche,
Victoriaville, Quebec; George Tsoukas, Applied Medical Informatics Research, Westmount,
Quebec; Michael Tsoukas, Applied Medical Informatics Research, Westmount, Ontario;
Vincent Woo , Winnipeg Regional Health Authority, Winnipeg, Ontario.

Denmark: Lise Tarnow, Trine Boesgaard, Martin Ridderstråle, Sidsel Christensen, Thomas
Dejgaard, Steno Diabetes Center, Gentofte; Søren Gregersen, Aarhus Sygehus THG, Aarhus
C; Anne Grethe, Schioldan, Aarhus Sygehus THG, Aarhus C; Kjeld Hermansen, Aarhus
Sygehus THG, Aarhus C; Mette Larsen, Aarhus Sygehus THG, Aarhus C; Filip K. Knop,
Kristian Mikkelsen, Morten Hansen, Medicinsk afdeling F., Hellerup; Thomas Olesen, Jan Erik
Henriksen, Lena Snogdal, Endokrinologisk afdeling M, Odense; Sten Madsbad, Ole
Snorgaard, Dorte Hansen, Endokrinologisk afdeling, Hvidovre Hospital; Tina Vilsbøll,
Medicinsk afdeling F., Hellerup.

Germany: Dominik Dahl, Wendisch/Dahl Hamburg, Hamburg; Ulrich Deuse, Esser, Essen;
Michael Esser, Esser, Essen, Essen; Katharina Gaede, Wendisch/Dahl Hamburg, Hamburg;
Andreas Hagenow, Zentrum für Klinische Studien Südbrandenburg GmbH, Elsterwerda;
Adam Kilimnik, Lüdemann, Falkensee; Dirk Lammers, Rose, Münster; Katharina Laubner,
Universitätsklinikum Freiburg, Freiburg; Hans-Peter Lüdemann, Lüdemann, Falkensee; Jörg
Lüdemann, Lüdemann, Falkensee, Falkensee; Dirk Mittag, Zentrum für Klinische Studien
Südbrandenburg GmbH, Elsterwerda; Harald Pohlmeier, Rose, Münster; Ludger Rose, Rose,
Münster, Münster; Thomas Schaum, RED-Institut für medizinische Studien und Fortbildung
GmbH, Oldenburg; Jochen Seufert, Universitätsklinikum Freiburg, Freiburg; Julia Thaler,
RED-Institut für Medizinische Studien und Fortbildung GmbH, Oldenburg; Ulrich Wendisch,
Wendisch/Dahl Hamburg, Hamburg.

7 
 
Israel: Mahmud Abo-Salook, Rabin MC Beilinson Campus Endo, Petah-Tikva; Ibrahim
Azzam, Institute of Endocrinology, metabolism and hypertension, Tel-Aviv; Yosefa Bar-
Dayan, Diabetes Clinic Wolfson MC, Holon; Issac Bar-or, Diabetes Clinic Wolfson MC, Holon;
Amir Bashkin, Institute of Diabetes, Western Galilee MC Nahariya, Nahariya; Amir Bashkin,
Institute of Diabetes, Western Galilee MC Nahariya, Nahariya; Carlos Benbassat, Rabin MC
Beilinson Campus Endo, Petah-Tikva; Avivit Cahn, Diabetes Unit Hadasa Ein Karem MC,
Jerusalem; Lea Chananashvili, Diabetes Clinic Wolfson MC, Holon; Yoav Eizenberg, Rabin
MC; Beilinson Campus Endo, Petah-Tikva; Dimitry Feldman, Diabetes Clinic Wolfson MC,
Holon; Svetlana Gershkov, Institute of Diabetes, Western Galilee MC Nahariya, Nahariya;
Alex Gorshtein, Rabin MC Beilinson Campus Endo, Petah-Tikva; Aaron Halabe, Diabetes
Clinic Wolfson MC, Holon; Dania Hirsch, Rabin MC Beilinson Campus Endo, Petah-Tikva;
Israel Hochman, Diabetes Clinic Wolfson MC, Holon; Jacob Ilany, Endrocrinolgy Clinic -
Sheba Medical Center, Tel Hashomer; Uri Inbal, Endrocrinolgy Clinic - Sheba Medical Center,
Tel Hashomer; Elena Izkhakov, Institute of Endocrinology, metabolism and hypertension,
Tel-Aviv; Avraham Karasik, Endrocrinolgy Clinic - Sheba Medical Center, Tel Hashomer;
Elena Kuyantseva, Institute of Diabetes, Western Galilee MC Nahariya, Nahariya; Irena
Leibovitch, Diabetes Clinic Wolfson MC, Holon; Gabriella Segal Lieberman, Endrocrinolgy
Clinic - Sheba Medical Center, Tel Hashomer; Hiba Masri-Iraqi, Rabin MC Beilinson Campus
Endo, Petah-Tikva; Leonid Michael, Endrocrinolgy Clinic - Sheba Medical Center, Tel
Hashomer; Ofri Mosenzon, Diabetes Unit Hadasa Ein Karem MC, Jerusalem; Marina
Nodelman, Institute of Diabetes, Western Galilee MC Nahariya, Nahariya; Ruth Percik,
Endrocrinolgy Clinic - Sheba Medical Center, Tel Hashomer; Marina Potekhin, Diabetes Unit
Hadasa Ein Karem MC, Jerusalem; Itamar Raz, Diabetes Unit Hadasa Ein Karem MC,
Jerusalem; Etal Robenshtok, Rabin MC Beilinson Campus Endo, Petah-Tikva; Merav Serebro,
Institute of Endocrinology, metabolism and hypertension, Tel-Aviv; Sigal Shaklai, Institute
of Endocrinology, metabolism and hypertension, Tel-Aviv; Ilan Shimon, Rabin MC Beilinson
Campus Endo, Petah-Tikva; Daniel Shpitz, Diabetes Clinic Wolfson MC, Holon; Joelle Singer,
Rabin MC Beilinson Campus Endo, Petah-Tikva; Ilana Slutzky, Rabin MC Beilinson Campus
Endo, Petah-Tikva; Naftali Stern, Institute of Endocrinology, metabolism and hypertension,
Tel-Aviv; Yulian Tilis, Diabetes Clinic Wolfson MC, Holon; Amit Tirosh, Rabin MC Beilinson
Campus Endo, Petah-Tikva; Gloria Tsvetov, Rabin MC Beilinson Campus Endo, Petah-Tikva;
Ira Vollach, Endrocrinolgy Clinic - Sheba Medical Center, Tel Hashomer; Julio Wainstein,
Diabetes Clinic Wolfson MC, Holon; Marianna Yaron, Institute of Endocrinology, metabolism
and hypertension, Tel-Aviv; Elena Zvulunov, Diabetes Clinic Wolfson MC, Holon.

Italy: Maria Pompea Antonia Baldassarre, Università degli Studi G. D'Annunzio, Chieti Scalo;
Anna Belligoli, Azienda Ospedaliera di Padova, Padova; Vera Bettini, Azienda Ospedaliera di
Padova, Padova; Rosamaria Di Biagio, Università degli Studi G. D'Annunzio, Chieti Scalo;
Silvia Bianchini, Centro Antidiabetico, Bologna; Ilario Carta, ASL no2 Olbia, OLBIA; Elena
Ceccarelli, Azienda Ospedaliera Universitaria Senese, Siena; Scilla Conci, Azienda
Ospedaliera di Padova, Padova; Agostino Consoli, Università degli Studi G. D'Annunzio,
Chieti Scalo; Giovanni Corona, Centro Antidiabetico, Bologna; Alessandro Roberto Dodesini,
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo; Francesco Dotta, Azienda Ospedaliera
Universitaria Senese, Siena; Roberto Fabris, Azienda Ospedaliera di Padova, Padova;
Fabrizio Febo, Università degli Studi G. D'Annunzio, Chieti Scalo; Patrizia Di Fulvio,

8 
 
Università degli Studi G. D'Annunzio, Chieti Scalo; Serena Isoni, ASL no2 Olbia, OLBIA;
Laura Nigi, Azienda Ospedaliera Universitaria Senese, Siena; Lorenzo Di Pizio, Università
degli Studi G. D'Annunzio, Chieti Scalo; Chiara Dal Prà, Azienda Ospedaliera di Padova,
Padova; Cristiana Scaranna, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo; Roberto
Serra, Azienda Ospedaliera di Padova, Padova; Alessandra Sforza, Centro Antidiabetico,
Bologna; Camilla Tinari, Università degli Studi G. D'Annunzio, Chieti Scalo; Giancarlo
Tonolo, ASL no2 Olbia, Olbia; Vania Torricelli, Azienda Ospedaliera Universitaria Senese,
Siena; Roberto Trevisan, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo; Roberto
Vettor, Azienda Ospedaliera di Padova, Padova; Stela Vujosevic, Azienda Ospedaliera di
Padova, Padova; Eva Zabeo, Azienda Ospedaliera di Padova, Padova; Veronica Zanato,
Azienda Ospedaliera di Padova, Padova.

Malaysia: Wan Azman Wan Ahmad, University Malaya Medical Centre, Kuala Lumpur; Nor
Hanim Amin, Sarawak General Hospital Heart Centre, Kota Samarahan; Yee Ling Cham,
Sarawak General Hospital Heart Centre, Kota Samarahan; Seng Chua, Sarawak General
Hospital Heart Centre, Kota Samarahan; Thurston Erng, Hospital Melaka, Melaka; Alan Yean
Yi Fong, Sarawak General Hospital Heart Centre, Kota Samarahan; Abd Kahar Abd Ghapar,
Hospital Serdang, Serdang; Ning Zan Khiew, Sarawak General Hospital Heart Centre, Kota
Samarahan; Yueh Chien Kuan, Sarawak General Hospital, Kuching; Bik Kiu Lau, Sarawak
General Hospital, Kuching; Gary Lee, Hospital Melaka, Melaka; Kien Chien Lim, Hospital
Melaka, Melaka; Kauthaman A. Mahendran, Hospital Melaka, Melaka; Abdul Muizz Abd
Malek, Hospital Serdang, Serdang; Tiong Kiam Ong, Sarawak General Hospital Heart
Centre, Kota Samarahan; Frederick Rozario, Sarawak General Hospital, Kuching; Asri Said,
Sarawak General Hospital Heart Centre, Kota Samarahan; Nor Ashikin Sari, University
Malaya Medical Centre, Kuala Lumpur; Radhakrishna Sothiratnam, Columbia Asia Medical
Center, Seremban; Ganiga Sridhar, University Malaya Medical Centre, Kuala Lumpur;
Florence Tan, Sarawak General Hospital, Kuching; Sian Kong Tan, Sarawak General Hospital
Heart Centre, Kota Samarahan; Lip Kai Tay, Hospital Serdang, Serdang; Julian Tey, Hospital
Melaka, Melaka; Shalini Vijayasingham, Hospital Melaka, Melaka; Chi Yen Voon, Sarawak
General Hospital Heart Centre, Kota Samarahan; Kuan Leong Yew, Sarawak General
Hospital Heart Centre, Kota Samarahan; Chan, Sarawak General Hospital, Kuching.

Mexico: Aurelia Baez-Campos, Instituto de Diabetes Obesidad y Nutricion S.C., Cuernavaca;

Bertha Martinez-Nolasco, Centro de Investigacion Clinica Endocrinologica de Jalisco,
Guadalajara; Carlos González-Valencia, Centro de Investigacion Clinica Endocrinologica de
Jalisco, Guadalajara; Carlos Villasana-Galeana, Ultimate Medica S.A. de C.V., México D.F.;
Carlos Olvera, Centro de Investigación Médico Biológica y Terapia, Guadalajara; Denisse
Castillo Reveles, Centro de Estudios de Investigación Metabólicos y Cardiovasc, Tampico;
Diana Larios-Mora, Centro de Investigacion Clinica Endocrinologica de Jalisco, Guadalajara;
Efrain Montaño-Gonzalez, Centro de Investigación Médico Biológica y Terapia, Guadalajara;
Elizabeth Pacheco Aranda, Fundacion Cardiovascular de Aguascalientes A.C.,
Aguascalientes; Elvia Hernandez Lopez, Centro de Estudios de Investigación Metabólicos y
Cardiovasc, Tampico; Emma Chavez Manzanera, Instituto Nacional de Ciencias Médicas y

9 
 
Nutrición, Mexico City; Fabián Luna-Martínez, Ultimate Medica S.A. de C.V., México D.F.;
Fernando Lopez-Hernandez, Centro de Investigacion Clinica Endocrinologica de Jalisco,
Guadalajara;

Francister Medina Alemán, Centro de Estudios de Investigación Metabólicos y Cardiovasc,

Tampico; Ignacio Rodriguez Briones, Carioarritmias e Investigación S.C., San Luis Potosi;
Irving Peralta-Cantu, Instituto de Diabetes Obesidad y Nutricion S.C., Cuernavaca; Israel
Olvera-Alvarez, Clínicos Asociados BOCM, S.C., Mexico City; Jose Alfredo Haro Ortiz,
Carioarritmias e Investigación S.C., San Luis Potosi; Jose de Jesus Marin-Lopez, Fundacion
Cardiovascular de Aguascalientes A.C., Aguascalientes; Juan Garcia Garcia, Instituto
Nacional de Ciencias Médicas y Nutrición, Mexico City; Juana Chávez Torres, Centro de
Estudios de Investigación Metabólicos y Cardiovasc, Tampico; Leobardo Sauque-Reyna,
Instituto de Diabetes Obesidad y Nutricion S.C., Cuernavaca; Lilia Aguilar-Parra, Centro de
Investigacion Clinica Endocrinologica de Jalisco, Guadalajara; Luis Virgen-Carrillo, Centro de
Investigacion Clinica Endocrinologica de Jalisco, Guadalajara; Luis Angel Amaya Morante,
Centro de Estudios de Investigación Metabólicos y Cardiovasc, Tampico; Luis Carmona
Furusho, Clínicos Asociados BOCM, S.C., Mexico City; Luz Reynaga, Centro de Estudios de
Investigación Metabólicos y Cardiovasc, Tampico; Maria Montaño-Gonzalez, Centro de
Investigación Médico Biológica y Terapia, Guadalajara; Maria del Carmen Juarez Cervantes,
Fundacion Cardiovascular de Aguascalientes A.C., Aguascalientes; Norma Martinez-Trejo,
Clínicos Asociados BOCM, S.C., Mexico City; Paola Gomez, Instituto Nacional de Ciencias
Médicas y Nutrición, Mexico City; Patricia Diaz De Leon-Reyes, Centro de Investigación
Médico Biológica y Terapia, Guadalajara; Paul-Baron Frenk, Ultimate Medica S.A. de C.V.,
México D.F.; Pedro Sanchez Vargas, Instituto de Diabetes Obesidad y Nutricion S.C.,
Cuernavaca; Rafael Margarito Violante Ortiz, Centro de Estudios de Investigación
Metabólicos y Cardiovasc, Tampico; Raul Estrada Garcia, Carioarritmias e Investigación
S.C., San Luis Potosi; Rocio Rodriguez Briones, Carioarritmias e Investigación S.C., San Luis
Potosi;

Rosa Gonzalez-Perez, Centro de Investigacion Clinica Endocrinologica de Jalisco,

Guadalajara; Rosa Lopez Covarrubias, Fundacion Cardiovascular de Aguascalientes A.C.,
Aguascalientes; Rosalinda Guerrero-Reyes, Fundacion Cardiovascular de Aguascalientes
A.C., Aguascalientes; Sara Chong-Garcia Torres, Centro de Estudios de Investigación
Metabólicos y Cardiovasc, Tampico; Silvia Jimenez-Ramos, Centro de Investigacion Clinica
Endocrinologica de Jalisco, Guadalajara.

Poland: Edyta Cichocka, Kat. i Klin. Chorob Wewnetrznych, Diabetologii i Nefrologii, Zabrze;
Ewa Czernecka, Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa; Magda
Dabrowska, Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa; Izabella Gladysz,
Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa; Janusz Gumprecht, Kat. i Klin.
Chorob Wewnetrznych, Diabetologii i Nefrologii, Zabrze; Katarzyna Jusiak, Synexus Polska
Sp. z o.o. Oddzial w Warszawie, Warszawa; Dorota Knychas, Synexus Polska Sp. z o.o.
Oddzial w Warszawie, Warszawa; Grazyna Laszewska, NSZOZ Osrodek Diabetologiczny
POPULA S.C., Bialystok; Maria Mazerska, NSZOZ Osrodek Diabetologiczny POPULA S.C.,
Bialystok; Katarzyna Nabrdalik, Kat. i Klin. Chorob Wewnetrznych, Diabetologii i Nefrologii,

10 
 
Zabrze; Elzbieta Poplawska, NSZOZ Osrodek Diabetologiczny POPULA S.C., Bialystok;
Andrzej Poplawski, NSZOZ Osrodek Diabetologiczny POPULA S.C., Bialystok; Urszula Puch,
NSZOZ Osrodek Diabetologiczny POPULA S.C., Bialystok; Piotr Romanczuk, NZOZ Gdanska
Poradnia Cukrzycowa, Gdansk; Wojciech Szydlowski, NZOZ CenterMed Lublin Sp. z o.o.,
Lublin; Ewa Szyprowska, NZOZ CenterMed Lublin Sp. z o.o., Lublin; Alina Walczak, Synexus
Polska Sp. z o.o. Oddzial w Warszawie, Warszawa; Bogumil Wolnik, NZOZ Gdanska Poradnia
Cukrzycowa, Gdansk.

Russian Federation: Yulia Arushanova (Matveeva), Academic out-patient clinic No1RAS,

Saint-Petersburg; Kh. Astamirova, Academic out-patient clinic No1 RAS, Saint-Petersburg;
Ekaterina Bukhalova, Clinical Hospital No1 NSMU, Novosibirsk; Veronika Dubova, Yaroslavl
Regional Hospital, Yaroslavl; Irina Dvoryashina, First City Clinical Hospital of the Emergency
Medical Care, Arkhangelsk; Elvira Edemskaya, Clinical Hospital No1 NSMU, Novosibirsk;
Leylya Gaysina, KNMU, RH No1, Kazan; Svetlana Gromova, Saratov regional clinical
hospital, Saratov; Irina Iskhakova (Tyutyunnikova), Clinical Hospital No1 NSMU,
Novosibirsk; Marina Kalashnikova, Setchenov Moscow State Medical University, Moscow;
Olga Kargapoltseva, Clinical Hospital No1NSMU, Novosibirsk; Lubov Kargina, SHI Saratov
City Clinical Hospital No9, Saratov; Kamila Kholmatova, First City Clinical Hospital of the
Emergency Medical Care, Arkhangelsk; Tatiana Kiseleva, KNMU, RH No1, Kazan; Ekaterina
Komissarova, Penza Regional Clinical Hospital named after N.N. Burdenko, Penza; Svetlana
Kovaleva, Penza Regional Clinical Hospital named after N.N. Burdenko, Penza; Elena
Kovalevskaia, Academic out-patient clinic No1 RAS, Saint-Petersburg; Inga Krivosheeva,
Clinical Hospital No1 NSMU, Novosibirsk; Tatiana Kufelkina, KNMU, RH No1, Kazan; Marina
Kunitsyna, Saratov regional clinical hospital, Saratov; Victoria Kurbanova, Academic out-
patient clinic No1 RAS, Saint-Petersburg; Natalia Likhodey, Setchenov Moscow State Medical
University, Moscow; Alena Lomova, Clinical Hospital No1 NSMU, Novosibirsk; Ludmila
Lvova, Academic out-patient clinic No1 RAS, Saint-Petersburg; Tatyana Lysenko, City
Hospital No5, Barnaul; Anna Malceva, City Hospital No5, Barnaul; Alexey Martinovich,
Smolensk State Medical Academy, Smolensk; Evgeniya Ogorodnikova, City Hospital No5,
Barnaul; Olga Osipova, SHI Saratov City Clinical Hospital No9, Saratov; Irina Ostrovskaya,
Saratov regional clinical hospital, Saratov;

Anna Postoeva, First City Clinical Hospital of the Emergency Medical Care, Arkhangelsk;
Natalya Prigoda, City Hospital No5, Barnaul; Dmitry Reshedko, Smolensk State Medical
Academy, Smolensk; Leonid Reshedko, Smolensk State Medical Academy, Smolensk; Galina
Reshedko, Smolensk State Medical Academy, Smolensk; Tatyana Rodionova, SHI Saratov
City Clinical Hospital No9, Saratov; Dmitriy Ruyatkin, Clinical Hospital No1 NSMU,
Novosibirsk; Ludmila Ruyatkina, Clinical Hospital No1 NSMU, Novosibirsk; Irina Samylina,
Penza Regional Clinical Hospital named after N.N. Burdenko, Penza; Ruslan Sardinov,
Academic out-patient clinic No1 RAS, Saint-Petersburg; Marina Sergeeva-Kondrachenko,
Penza Regional Clinical Hospital named after N.N. Burdenko, Penza; Elena Shabanova,
Clinical Hospital No1 NSMU, Novosibirsk; Natalia Shatkovskaya, SHI Saratov City Clinical
Hospital No9, Saratov; Nadezhda Shilina (Kutuzova), Clinical Hospital No1 NSMU,
Novosibirsk; Olga Shimokhina, Penza Regional Clinical Hospital named after N.N. Burdenko,
Penza; Anna Shuvaeva, SHI Saratov City Clinical Hospital No9, Saratov; Ekaterina Sorkina,

11 
 
Setchenov Moscow State Medical University, Moscow; Maxim Sorokin, Clinical Hospital No1
NSMU, Novosibirsk; Larisa Suvorova, Saratov regional clinical hospital, Saratov; Yulia Sych,
Setchenov Moscow State Medical University, Moscow; Natalya Talalaeva, Clinical Hospital
No1 NSMU, Novosibirsk; Alfiya Valeeva, KNMU, RH No1, Kazan; Farida Valeeva, KNMU, RH
No1, Kazan; Valentina Vinokurova, Saratov regional clinical hospital, Saratov; Elena
Yanovskaya, Yaroslavl Regional Hospital, Yaroslavl; Maria Yanovskaya, Yaroslavl Regional
Hospital, Yaroslavl; Tatiana Zakharova, Yaroslavl Regional Hospital, Yaroslavl; Elena
Zhukova, Saratov regional clinical hospital, Saratov; Irina Zimina, Academic out-patient
clinic No1 RAS, Saint-Petersburg; Anastasia Zinenko, SHI Saratov City Clinical Hospital No9,
Saratov; Galina Znamenshchikova, SHI Saratov City Clinical Hospital No9, Saratov.

Spain: Beatriz Pérez Arr Arroyo, Hospital Quirón, Pozuelo de Alarcon; Manuel Beltrán,
Hospital Virgen del Camino, Sanlúcar de Barrameda; Héctor García Bidón, Hospital Infanta
Luisa, Sevilla; Daniel Cepero, Clínica San Pedro, Almería; Jesús María Sedeño Díaz, Hospital
Comarcal de Antequera, Antequera; Javier Elvira, Hospital Virgen del Camino, Sanlúcar de
Barrameda; Margarita Rivas Fernández, Hospital Infanta Luisa, Sevilla; Maria Angels Obiols
Fornells, Centro de Atención Primaria El Remei, Vic (Barcelona); Esteban Jodar, Hospital
Quirón, Pozuelo de Alarcon; Miguel Ángel García Ordóñez, Hospital Comarcal de Antequera,
Antequera; Antonio Bascuñana Quirell, Hospital Virgen del Camino, Sanlúcar de Barrameda;
Pedro Mezquita Raya, Clínica San Pedro, Almería; Rebeca Reyes, Clínica San Pedro, Almería;
Antonio Ruiz Serra, Hospital Comarcal de Antequera, Antequera; Marta Serrarols Soldevila,
Centro de Atención Primaria El Remei, Vic (Barcelona); Alejandro López Suarez, Hospital
Virgen del Camino, Sanlúcar de Barrameda; Manel Terns, Centro de Atención Primaria El
Remei, Vic (Barcelona).

Taiwan: Jeng-Yeou Chen, Chang Gung Medical Foundation - Linko Branch, Taoyuan; Chien-
Wen Chou, Chi Mei Medical Center, Tainan city; Chih-Tsueng He, Tri-Service General
Hospital, Taipei; Chang-Hsun Hsieh, Tri-Service General Hospital, Taipei; Brend Ray-Sea
Hsu, Chang Gung Medical Foundation - Linko Branch, Taoyuan; Shih-Che Hua, Ditmanson
Medical Foundation Chia-Yi Christian Hospital, Chiayi City; Chung-Huei Huang, Chang Gung
Medical Foundation - Linko Branch, Taoyuan; Yu-Yao Huang, Chang Gung Medical
Foundation - Linko Branch, Taoyuan; Yi-Jen Hung, Tri-Service General Hospital, Taipei;
Chien Lee, Tri-Service General Hospital, Taipei; Chen-Wei Lin, Chang Gung Medical
Foundation - Linko Branch, Taoyuan; Chia-Hung Lin, Chang Gung Medical Foundation -
Linko Branch, Taoyuan; Miaw-Jene Liou, Chang Gung Medical Foundation - Linko Branch,
Taoyuan; Wen-Tsung Lu, Chang Gung Medical Foundation - Linko Branch, Taoyuan; Chieh-
Hsiang Lu, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi City; Jui-Hung
Sun, Chang Gung Medical Foundation - Linko Branch, Taoyuan; Tsai-Sung Tai, Ditmanson
Medical Foundation Chia-Yi Christian Hospital, Chiayi City; Kai-Jen Tien, Chi Mei Medical
Center, Tainan city; Kai-Jen Tien, Chi Mei Medical Center, Tainan city; Chih-Ching Wang,
Chang Gung Medical Foundation - Linko Branch, Taoyuan; Ling-Yi Wu, Tri-Service General
Hospital, Taipei; Chwen-Yi Yang, Chi Mei Medical Center, Tainan city; Feng Chieh Yen, Chi

12 
 
Mei Medical Center, Tainan city; Hui-I Yu, Ditmanson Medical Foundation Chia-Yi Christian
Hospital, Chiayi City.

Thailand: Thananya Boonyasirinant, Siriraj Hospital, Bangkok; Apussanee Boonyavarakul,

Phramongkutklao Hospital, Bangkok; Chaicharn Deerochanawong, Rajavithi Hospital,
Bangkok; Wisuit Katekao, Ramathibodi Hospital, Bangkok; Adisak Maneesai, Siriraj Hospital,
Bangkok; Witthawat Naeowong, King Chulalongkorn Memorial Hospital, Bangkok; Satchana
Pumprueg, Siriraj Hospital, Bangkok; Panudda Srichomkwun, King Chulalongkorn Memorial
Hospital, Bangkok; Charn Sriratanasathavorn, Siriraj Hospital, Bangkok; Piyamitr Sritara,
Ramathibodi Hospital, Bangkok; Sarat Sunthornyothin, King Chulalongkorn Memorial
Hospital, Bangkok; Sirakarn Tejavanija, Phramongkutklao Hospital, Bangkok; Varinsawat
Thirawuth, Ramathibodi Hospital, Bangkok; Phanthaboon Wangpatharawanit, Ramathibodi
Hospital, Bangkok; Lalita Wattanachanya, King Chulalongkorn Memorial Hospital, Bangkok;
Nattawut Wongpraparut, Siriraj Hospital, Bangkok.

Turkey: Suleyman Ahbab, Haseki Egitim ve Arastirma Hastanesi, Istanbul; Fulya Akin,
Pamukkale Universitesi Tip Fakultesi, Denizli; Baris Akinci, Dokuz Eylul University Medical
Faculty, Izmir; Ozlem Akyay, Kocaeli Universitesi Tip Fakultesi Hastanesi, Kocaeli; Hasan
Altunbas, Akdeniz University Tip Fakultesi Hastanesi, Antalya; Mahmut Apaydin, Ankara
Diskapi Yildirim Beyazit Egitim-Arastirma Hastanesi, Ankara; Mehmet Asik, 18 Mart
University School of Medicine, Canakkale; Esra Ataoglu, Haseki Egitim ve Arastirma
Hastanesi, Istanbul; Alp Atasoy, Haseki Egitim ve Arastirma Hastanesi, Istanbul; Muzeyyen
Arslan Bahadir, Goztepe Egitim ve Arastirma Hastanesi, Istanbul; Selvihan Beysel, Ankara
Diskapi Yildirim Beyazit Egitim-Arastirma Hastanesi, Ankara; Erman Cakal, Ankara Diskapi
Yildirim Beyazit Egitim-Arastirma Hastanesi, Ankara; Mehmet Calan, Dokuz Eylul University
Medical Faculty, Izmir; Mustafa Caliskan, Ankara Diskapi Yildirim Beyazit Egitim-Arastirma
Hastanesi, Ankara; Umit Cavdar, Dokuz Eylul University Medical Faculty, Izmir;
Abdurrahman Comlekci, Dokuz Eylul University Medical Faculty, Izmir; Tuncay Delibasi,
Ankara Diskapi Yildirim Beyazit Egitim-Arastirma Hastanesi, Ankara; Tevfik Demir, Dokuz
Eylul University Medical Faculty, Izmir; Taner Demirci, Ankara Diskapi Yildirim Beyazit
Egitim-Arastirma Hastanesi, Ankara; Burcu Dogan, Goztepe Egitim ve Arastirma Hastanesi,
Istanbul; Halil Dönmez, Haseki Egitim ve Arastirma Hastanesi, Istanbul; Abdul Ergen,
Haseki Egitim ve Arastirma Hastanesi, Istanbul; Mustafa Eroglu, 18 Mart University School
of Medicine, Canakkale; Mehmet Erturk, Pamukkale Universitesi Tip Fakultesi, Denizli;
Serdar Guler, Ankara Numune Training and Research Hospital, Ankara; Tugba Gumus,
Dokuz Eylul University Medical Faculty, Izmir; Savas Gur, 18 Mart University School of
Medicine, Canakkale; Narin Imga, Ankara Numune Training and Research Hospital, Ankara;
Seyfullah Kan, Ankara Diskapi Yildirim Beyazit Egitim-Arastirma Hastanesi, Ankara; Ersen
Karakilic, Ankara Numune Training and Research Hospital, Ankara; Melia Karakose, Ankara
Diskapi Yildirim Beyazit Egitim-Arastirma Hastanesi, Ankara; Muhammed Kizilgul, Ankara
Diskapi Yildirim Beyazit Egitim-Arastirma Hastanesi, Ankara; Banu Alpaslan Mesci, Goztepe
Egitim ve Arastirma Hastanesi, Istanbul; Aytekin Oguz, Goztepe Egitim ve Arastirma
Hastanesi, Istanbul; Ekrem Orbay, Dr Lutfu Kirdar Kartal Egitim ve Arastirma Hastanesi,

13 
 
Istanbul; Ozgur Ozcelik, Ankara Diskapi Yildirim Beyazit Egitim-Arastirma Hastanesi,
Ankara; Sengul Ozcelik, 18 Mart University School of Medicine, Canakkale; Secil Ozisik,
Dokuz Eylul University Medical Faculty, Izmir; Fatma Saglam, Ankara Numune Training and
Research Hospital, Ankara; Hatice Sagun, Goztepe Egitim ve Arastirma Hastanesi, Istanbul;
Nilay Samanci, Haseki Egitim ve Arastirma Hastanesi, Istanbul; Ramazan Sari, Akdeniz
University Tip Fakultesi Hastanesi, Antalya; Alev Selek, Kocaeli Universitesi Tip Fakultesi
Hastanesi, Kocaeli; Aysun Semerci, Goztepe Egitim ve Arastirma Hastanesi, Istanbul;
Meryem Tahmaz, Haseki Egitim ve Arastirma Hastanesi, Istanbul; Ilhan Tarkun, Kocaeli
Universitesi Tip Fakultesi Hastanesi, Kocaeli; Oya Topaloglu, Ankara Diskapi Yildirim Beyazit
Egitim-Arastirma Hastanesi, Ankara; Senay Topsakal, Pamukkale Universitesi Tip Fakultesi,
Denizli; Fatih Turker, Haseki Egitim ve Arastirma Hastanesi, Istanbul; Esra Tutal, Ankara
Diskapi Yildirim Beyazit Egitim-Arastirma Hastanesi, Ankara; Bekir Ucan, Ankara Diskapi
Yildirim Beyazit Egitim-Arastirma Hastanesi, Ankara; Kubilay Ukinc, 18 Mart University
School of Medicine, Canakkale; Guzin Yaylali, Pamukkale Universitesi Tip Fakultesi, Denizli;
Serkan Yener, Dokuz Eylul University Medical Faculty, Izmir; Mustafa Yenigun, Haseki Egitim
ve Arastirma Hastanesi, Istanbul; Emrah Yerlikaya, Pamukkale Universitesi Tip Fakultesi,
Denizli.

United Kingdom: Prakash Abraham, Aberdeen Royal Infirmary, Aberdeen; Saboor Aftab,
MeDiNova South London Clinical Studies Centre, Sidcup; Saboor Aftab, MeDiNova South
London Clinical Studies Centre, Sidcup; Saboor Aftab, MeDiNova South London Clinical
Studies Centre, Sidcup; Stephen Bain, Morriston Hospital, Swansea; Srikanth Bellary,
Diabetes Centre, Heartlands Hospital, Birmingham, Birmingham; Ann Cadzow, Aberdeen
Royal Infirmary, Aberdeen; Balgit Chhokar, MeDiNova South London Clinical Studies Centre,
Sidcup; Balgit Chhokar, MeDiNova South London Clinical Studies Centre, Sidcup; M
Deshpande, MediNova North London Clinical Studies Centre, Northwood; M Deshpande,
MediNova North London Clinical Studies Centre, Northwood; Louise Devany, Moorfield
House Surgery, Leeds; Louise Devany, Moorfield House Surgery, Leeds; Pratiksha Dokhe,
MediNova North London Clinical Studies Centre, Northwood; Ahmed Elshashai, MediNova
North London Clinical Studies Centre, Northwood; Salvatore Febbraro, Morriston Hospital,
Swansea; Janet Inkster, Aberdeen Royal Infirmary, Aberdeen; Parminderjit Jayia, MeDiNova
South London Clinical Studies Centre, Sidcup; Parminderjit Jayia, MediNova North London
Clinical Studies Centre, Northwood; Uttura Kurup, MeDiNova South London Clinical Studies
Centre, Sidcup; Nadia Lascar, Diabetes Centre, Heartlands Hospital, Birmingham,
Birmingham; Judith MacKay, MediNova North London Clinical Studies Centre, Northwood;
Surya Rajeev, University Hospital Aintree, Liverpool; Ian Seetho, University Hospital
Aintree, Liverpool; Hannah Shiels, Department of Diabetes, Torquay; Urmi Shukla,
MeDiNova South London Clinical Studies Centre, Sidcup; Jamie Smith, Department of
Diabetes, Torquay; Daniela Stanciu, MediNova North London Clinical Studies Centre,
Northwood; Gowri Subramanian, MeDiNova South London Clinical Studies Centre, Sidcup;
Jonathan Taylor, Moorfield House Surgery, Leeds; Davinda Weeraratne, MediNova North
London Clinical Studies Centre, Northwood; John Wilding, University Hospital Aintree,
Liverpool.

14 
 
United States: Marconi Abreu, UT Southwestern Medical Center at Dallas, Dallas; John
Agaiby, Clinical Investigation Specialists Inc, Gurnee; Eva Agaiby, Clinical Investigation
Specialists Inc, Gurnee; Ana Aguillon, Facey Medical Foundation, Mission Hills; Syed Ahmed,
Stanley F. Stockhammer, Jr. D.O. P.A., Deland; Rachid Alaoui, Carl R. Meisner Medical
Clinic, PLLC, Sugarland; Stephanie Alarcon, Carl R. Meisner Medical Clinic, PLLC, Sugarland;
Lori Alexander, St Johns Center For Clinical Research, Ponte Vedra; Asim Ali, St. Louis
Medical Center for Clinical Research, St. Louis; Kay Allen, Dallas Diabetes & Endocrine
Center, Dallas; Thouraya Al-Maliky, Saint Luke's Lipid and Diabetes Research Center,
Kansas City; Madiha Alvi, University of Vermont Medical Center, South Burlington; James
Andersen, Meridien Research, Brooksville; Vincent Anthony, American Institute of Research,
Los Angeles; Sirlys Arcon-Rios, Harold Hamm Diabetes Ctr at the Univ of Oklahoma,
Oklahoma City; David Arkin, Physician Research Associates, LLC, Lawrenceville; Bassam
Arodak, Harold Hamm Diabetes Ctr at the Univ of Oklahoma, Oklahoma City; Sonia Arroyo,
La Porte County Institute For Clinical Research, Michigan City; Imad Asmar, American
Institute of Research, Los Angeles; Susan Attel, Radiant Research Inc. - Dallas, Dallas;
Madona Azar, Harold Hamm Diabetes Ctr at the Univ of Oklahoma, Oklahoma City; Ammara
Aziz, Harold Hamm Diabetes Ctr at the Univ of Oklahoma, Oklahoma City; Masoud Azizad,
Valley Clinical Trials, Northridge; Trista Bachand, Diabetes and Thyroid Center of Fort
Worth, Fort Worth; Mara Baier, Radiant Research Inc., Arizona, Phoenix; Chris Bajaj,
Diabetes and Thyroid Center of Fort Worth, Fort Worth; Claire Baker, Diabetes & Endocrine
Associates PC, Omaha; Chelsea Baker, University of Colorado Denver, Aurora; Constance
Baker, PMG Research of Wilmington, LLC, Wilmington; Tracy Balentine, Meridien Research,
Bradenton; Thomas Ballard, Mountain View Clinical Research Inc, Greer; Salomon Banarer,
Dallas Diabetes & Endocrine Center, Dallas; James Banks, Mercy Health Research, St. Louis;
George Barchini, Chase Medical Research LLC, Waterbury; Joel Barra, American Institute of
Research, Los Angeles; John Barrett, Primary Care Research South, Inc, McMurray; Darlene
Bartilucci, Jacksonville Center For Clinical Research, Jacksonville; Nicole Bauer, Mercy
Health Research, St. Louis; Howard Baum, Diabetes and Obesity Clinical Trials Center,
Nashville; Margaret Baumann, Sterling Research Group, Ltd., Cincinnati; Jessica Bax, Facey
Medical Foundation, Mission Hills; Harold Bays, L-MARC Research Center, Louisville; Karen
Becerra, Carl R. Meisner Medical Clinic, PLLC, Sugarland; Gary Bedel, Prestige Clinical
Research, Franklin; Noreen Behl, L-MARC Research Center, Louisville; Amy Bell, University
Of Tennessee, Memphis; Brenda Benavidez, Briggs Clinical Research, LLC, San Antonio;
William Bender, Amherst Family Practice, Winchester; Katherine Bergamo, University of
North Carolina, UNC Diabetes Care Center, Chapel Hill; Richard Bernstein, Marin Endocrine
Care & Research, Inc., Greenbrae; Martha Berry, Arthritis And Diabetes Clinic, Inc., Monroe;
William Bestermann, Holston Medical Group, Kingsport; Matthew Beyea, Clinical Study
Center Of Asheville LLC, Asheville; Rhajiv Bhambri, MIMA Century Research Associates,
Melbourne; C. Robert Bice, Holston Medical Group, Kingsport; Alistaire Bilas, Anaheim
Clinical Trials, LLC, Anaheim; Keisha Bishop, Radiant Research Inc., Dallas; Lacey Bixler,
Harold Hamm Diabetes Ctr at the Univ of Oklahoma, Oklahoma City; Caitlin Blair, Amherst
Family Practice, Winchester; Otilia Boncu, Midwest CRC, Crystal Lake; Jo Bonner, Mercy
Health Research, St. Louis; Azael Borromeo, Nature Coast Clinical Research - Crystal River,
Crystal River; Emad Botros, Selma Medical Associates, Winchester; Gary Boyd, Achieve
Clinical Research LLC, Birmingham; Charlotte Bragg, Univ of AL Preventive Medicine,
Birmingham; Amber Brassfield, Optimal Research, San Diego; Jeanne Breen, University of

15 
 
Colorado, Aurora; Michael Brennan, Rochester Clinical Research, Inc., Rochester; Shannon
Brewington, Meridien Research, Brooksville; Charles Bricker, Wenatchee Valley Hospital and
Clinics, Wenatchee; Charles Brickner, Wenatchee Valley Hospital and Clinics, Wenatchee;
Monica Brown, Valley Clinical Trials, Northridge; April Brown, Advanced Medical Research,
Maumee; Danielle Bryant, Physician's East Endocrinology, Greenville; Genena Buck,
Physician's East Endocrinology, Greenville; Brandee Buckley, UT Southwestern Medical
Center at Dallas, Dallas; Susan Budzinski, Nature Coast Clinical Research - Crystal River,
Crystal River; Julie Bukowski, Advanced Medical Research, Maumee; Holly Bunyard, Saint
Luke's Lipid and Diabetes Research Center, Kansas City; Tara Burdette, Clinical Study
Center Of Asheville LLC, Asheville; Casey Burgess-Blalock, Asheboro Research Associates,
Asheboro; Anna Burton, Achieve Clinical Research LLC, Birmingham; Robert Busch, Albany
Medical College, Division of Community Endocrinology, Albany; John Buse, University of
North Carolina, UNC Diabetes Care Center, Chapel Hill; Denise Bushong, L-MARC Research
Center, Louisville; Nancy Butler, Primary Care Research South, Inc, McMurray; William
Byars, Mountain View Clinical Research Inc, Greer; Kevin Bybee, Saint Luke's Lipid and
Diabetes Research Center, Kansas City; Kevin Bybee, Saint Luke's Lipid and Diabetes
Research Center, Kansas City; Robin Bye, Tulane University Health Sciences Center, New
Orleans; Joyce Byers, Borgess Diabetes and Endocrine Center, Kalamazoo; Ronald Caldwell,
Clinical Study Center Of Asheville LLC, Asheville; Ronald Caldwell, Clinical Study Center Of
Asheville LLC, Asheville; Krystle Calvin, La Porte County Institute For Clinical Research,
Michigan City; Allison Camacho, Dallas Diabetes & Endocrine Center, Dallas; John Cameron,
Asheboro Research Associates, Asheboro; Melanie Cannon, Harold Hamm Diabetes Ctr at
the Univ of Oklahoma, Oklahoma City; Daniel Cannon, Clinical Study Center Of Asheville
LLC, Asheville; Kevin Cannon, PMG Research of Wilmington, LLC, Wilmington; Jonna
Capuchino, Meridien Research, Brooksville; Sally Cardella, Rochester Clinical Research, Inc.,
Rochester; Lisa Carmolli-Cornette, Southern New Hampshire Diabetes and Endocrinology,
Nashua; Gandahari Carpio, Tulane University Health Sciences Center, New Orleans;
Kimberely Casagni, Chase Medical Research LLC, Waterbury; Bettina Cassell, Heartland
Research Associates LLC, Wichita; Cathleen Castay, Mountain View Clinical Research Inc,
Greer; Victoria Catenacci, University of Colorado, Aurora; Janis Cerullo, Heartland Research
Associates LLC, Wichita; Sushela Chaidarun, Dartmouth-Hitchcock Medical Center, Lebanon;
Joseph Chambers, Facey Medical Foundation, Mission Hills; Louis Chaykin, Meridien
Research, Bradenton; Amanda Cherry, Physician's East Endocrinology, Greenville; Theresa
Cheyne, Diabetes and Thyroid Center of Fort Worth, Fort Worth; Ronald Chochinov, Coastal
Metabolic Research Center, Ventura; James Choe, Harold Hamm Diabetes Ctr at the Univ of
Oklahoma, Oklahoma City; Christopher Chow, Valley Clinical Trials, Northridge; Melanie
Christina, Clinical Investigations Of Texas, Plano; Suzette Christopher, Diabetes And
Endocrinology Specialists Inc., Chesterfield; James Chu, Monterey Endocrine & Diabetes
Institute, Inc, Monterey; Ellie Chuang, Southern New Hampshire Diabetes and
Endocrinology, Nashua; Lara Church, St Johns Center For Clinical Research, Ponte Vedra;
Anthony Ciampa, Primary Care Research South, Inc, McMurray; Erik Cohen, Albany Medical
College, Division of Community Endocrinology, Albany; Neil Cohen, University Physicians
Group, Staten Island; Brittany Collins, Dominion Medical Associates, Richmond; Judy
Combs, Achieve Clinical Research LLC, Birmingham; Richard Comi, Dartmouth-Hitchcock
Medical Center, Lebanon; Brittany Conn, L-MARC Research Center, Louisville; Dorothy Cook,
Renstar Medical Research, Ocala; Cheryl Correll, University Physicians Group, Staten Island;

16 
 
Guadelupe Cortes, Facey Medical Foundation, Mission Hills; Anita Cortez, Oxford Clinical
Research, LLC, Houston; Damian Covington, Dominion Medical Associates, Richmond;
Sharron Critchson, Accelovance, Melbourne; Dawn Culmer, University of North Carolina,
UNC Diabetes Care Center, Chapel Hill; Linda Cunningham, Southgate Medical Group, LLP,
West Seneca; James Curll, Briggs Clinical Research, LLC, San Antonio; Nizar Daboul,
Advanced Medical Research, Maumee; Samuel Dagogo-Jack, University Of Tennessee,
Memphis; Samuel Dagogo-Jack, University Of Tennessee, Memphis; Kristie Daly-Barnes,
Physician's East Endocrinology, Greenville; Andy Dang, Facey Medical Foundation, Mission
Hills; Andy Dang, Facey Medical Foundation, Mission Hills; David Daniels, Meridien
Research, Brooksville; Haley Darlington, Wenatchee Valley Hospital and Clinics, Wenatchee;
Matthew Davis, Rochester Clinical Research, Inc., Rochester; Randall Daynes, Wasatch
Clinical Research, Salt Lake City; Therese Dayton, Rochester Clinical Research, Inc.,
Rochester; John Dean, Clinical Study Center Of Asheville LLC, Asheville; David DeAtkine,
Achieve Clinical Research LLC, Birmingham; Elizabeth Delgado, Anaheim Clinical Trials, LLC,
Anaheim; Michael DeMicco, Anaheim Clinical Trials, LLC, Anaheim; Dina DeSalle, Heritage
Valley Medical Group, Beaver; Cyrus Desouza, University Of Nebraska Medical Center,
Omaha; Deborah Devlin, Diabetes and Thyroid Center of Fort Worth, Fort Worth; Milana
Dezube, University of North Carolina, UNC Diabetes Care Center, Chapel Hill; Nancy
DiCerbo, Albany Medical College, Division of Community Endocrinology, Albany; Maureen
DiDonato, Founders Research Corporation, Philadelphia; Amy Diesburg-Stanwood,
University of Colorado Denver, Aurora; Jennifer Dilembo, Radiant Research Inc. - Arizona,
Phoenix; Philip Diller, Sterling Research Group, Ltd., Cincinnati; Jaime Diner, University of
North Carolina, UNC Diabetes Care Center, Chapel Hill; Dawn Dluge-Aungst, Albany Medical
College, Division of Community Endocrinology, Albany; Regina Dodis, Physician's East
Endocrinology, Greenville; Amanda Donoho, Holston Medical Group, Kingsport; Isaac Dor,
Clinical Investigation Specialists Inc, Gurnee; Nathan Doremus, American Institute of
Research, Los Angeles; David Doriguzzi, First Valley Medical Group, Lancaster; Jean Dostou,
University of North Carolina, UNC Diabetes Care Center, Chapel Hill; Sara Douglass,
University of Colorado Denver, Aurora; Michelle Dowell, Meridien Research, Bradenton;
Brenda Draper, Clinical Study Center Of Asheville LLC, Asheville; Andjela Drincic, University
Of Nebraska Medical Center, Omaha; Haiming Du, University Of Tennessee, Memphis;
Steven Duckor, Anaheim Clinical Trials, LLC, Anaheim; Michelle Duclos, University of North
Carolina, UNC Diabetes Care Center, Chapel Hill; Bobbi Duffy-Hidalgo, Chase Medical
Research LLC, Waterbury; Carol Duma, Albany Medical College, Division of Community
Endocrinology, Albany; Sheri Duncan, Heartland Research Associates LLC, Wichita; Raegan
Durant, Univ of AL Preventive Medicine, Birmingham; Nancy Durham, Mountain View
Clinical Research Inc, Greer; Jaclyn Dusek, Rochester Clinical Research, Inc., Rochester;
Donald Eagerton, Carolina Health Specialists, Myrtle Beach; Kathleen Ebeling, Rochester
Clinical Research, Inc., Rochester; Sotonte Ebenibo, University Of Tennessee, Memphis;
Chimaroke Edeoga, University Of Tennessee, Memphis; Robin Edgett, Rochester Clinical
Research, Inc., Rochester; Gina Edwards, Panacea Clinical Research, San Antonio; Jessica
Edwin, University Physicians Group, Staten Island; Richard Egelhof, Heartland Research
Associates LLC, Wichita; James Ekwensi, University Of Tennessee, Memphis; Theresa
Ohlson Elliott, Southgate Medical Group, LLP, West Seneca; Miles Elmore, Clinical Study
Center Of Asheville LLC, Asheville; Diane Elson, University Of Wisconsin-Madison, Madison;
Laurie Emmert, Meridien Research, Bradenton; Leslie Entriken, Heartland Research

17 
 
Associates LLC, Wichita; Holly Van Epps, AM Diabetes And Endocrinology Center, Bartlett;
Monica Erie, Meridien Research, Brooksville; Brian Everhart, Heritage Valley Medical Group,
Beaver; Mildred Farmer, Meridien Research, Bradenton; Darren Farnesi, Optimal Research,
San Diego; Leora Fernandes, Infinity Medical Research, North Dartmouth; Beth Ferrington,
Arthritis And Diabetes Clinic, Inc., Monroe; Vicky Fink, Rochester Clinical Research, Inc.,
Rochester; Norman Fishman, Diabetes And Endocrinology Specialists Inc., Chesterfield;
Christine Florida, Anaheim Clinical Trials, LLC, Anaheim; Alan Forker, Saint Luke's Lipid and
Diabetes Research Center, Kansas City; Alan Forker, Saint Luke's Lipid and Diabetes
Research Center, Kansas City; John Forward, Internal Medicine Of Morris County, Mine Hill;
Karen Freudemann, Sterling Research Group, Ltd., Cincinnati; Gail Fuller, University of
North Carolina, UNC Diabetes Care Center, Chapel Hill; Gene Fuller, Wasatch Clinical
Research, Salt Lake City; Frank Fusco, Renstar Medical Research, Ocala; Peter Gagianas,
Primary Care Research South, Inc, McMurray; Robert Galagan, Tulane University Health
Sciences Center, New Orleans; Allison Galloway, Harold Hamm Diabetes Ctr at the Univ of
Oklahoma, Oklahoma City; Elizabeth Gansner, Mercy Health Research, St. Louis; Raul
Gaona, Briggs Clinical Research, LLC, San Antonio; Idolina Garcia, Clinical Investigations Of
Texas, Plano; Gabriel Garcia, Coastal Metabolic Research Center, Ventura; Maureen Garvin,
University Of Nebraska Medical Center, Omaha; Linda Gaudiani, Marin Endocrine Care &
Research, Inc., Greenbrae; Jennifer Gault, Wenatchee Valley Hospital and Clinics,
Wenatchee; Miroslav Gavazov, Wake Research Associates, Raleigh; Michael Gawad, Facey
Medical Foundation, Mission Hills; Cassandra Gedbaw, University of Colorado Denver,
Aurora; Carmela Gerace, St Johns Center For Clinical Research, Ponte Vedra; Matthew
Gilbert, University of Vermont Medical Center, South Burlington; Sarah Godwin, Physician's
East Endocrinology, Greenville; Tambra Goebel, Optimal Research, San Diego; April Goley,
University of North Carolina, UNC Diabetes Care Center, Chapel Hill; Laura Golici, UT
Southwestern Medical Center at Dallas, Dallas; M. Antonieta Gonzalez, Briggs Clinical
Research, LLC, San Antonio; Charlene Goodhart, Albert J Weisbrot, Mason; Aidar
Gosmanov, University Of Tennessee, Memphis; Ketan Goswami, Physician Research
Associates, LLC, Lawrenceville; Stephanie Gray, Radiant Research Inc. - Arizona, Phoenix;
Susan Greco, Jacksonville Center For Clinical Research, Jacksonville; Carrie Green, DCOL
Center for Clinical Research, Longview; Craig Greenberg, Borgess Diabetes and Endocrine
Center, Kalamazoo; Craig Greenberg, Borgess Diabetes and Endocrine Center, Kalamazoo;
Julie Griffen, Prestige Clinical Research, Franklin; Peggy Gruenther, Selma Medical
Associates, Winchester; Liliana Guadron-Hernandez, Facey Medical Foundation, Mission
Hills; Lisa Guasp, Rochester Clinical Research, Inc., Rochester; Michael Guice, American
Institute of Research, Los Angeles; David Gunther, Southgate Medical Group, LLP, West
Seneca; Harry Gustin, Amherst Family Practice, Winchester; Haydee Gutierrez, Valley
Clinical Trials, Northridge; Amina Haggag, Anaheim Clinical Trials, LLC, Anaheim; Michelle
Haggar, Tulane University Health Sciences Center, New Orleans; Judy Hammond, Carolina
Health Specialists, Myrtle Beach; April Hanyok, PMG Research of Wilmington, LLC,
Wilmington; Chelsey Hardy, Heartland Research Associates LLC, Wichita; Wayne Harper,
Wake Research Associates, Raleigh; Wendy Harrell, Mountain View Clinical Research Inc,
Greer; Elizabeth Harris, University of North Carolina, UNC Diabetes Care Center, Chapel Hill;
Lindsay Harrison, UT Southwestern Medical Center at Dallas, Dallas; Rebecca Hartsell, La
Porte County Institute For Clinical Research, Michigan City; Myra Haseeb, Pangtay Research
Corporation, MSCI, Irving; Amber Hastings, Heartland Research Associates LLC, Wichita;

18 
 
Denise Hayes, Radiant Research Inc. - Dallas, Dallas; Carolyn Hedrick, Asheboro Research
Associates, Asheboro; Laura Helman, Optimal Research, LLC, Mishawaka; Max Helman,
Optimal Research, LLC, Mishawaka; Ashley Helton, Holston Medical Group, Kingsport; Mary
Hendrick, Meridien Research, Bradenton; Chase Hendrickson, Dartmouth-Hitchcock Medical
Center, Lebanon; Gayle Hennekes, Sterling Research Group, Ltd., Cincinnati; Ashley Herbst,
Radiant Research Inc. - Arizona, Phoenix; Graciela Hernandez, Coastal Metabolic Research
Center, Ventura; Charles Herring, PMG Research of Wilmington, LLC, Wilmington; Erika
Hess, Panacea Clinical Research, San Antonio; Belinda Hilliard, AM Diabetes And
Endocrinology Center, Bartlett; Emily Hoagland, University of Colorado, Aurora; Eric
Hoberman, Southern New Hampshire Diabetes and Endocrinology, Nashua; Lisa Hoffman,
Southgate Medical Group, LLP, West Seneca; Amanda Hoffmann, Advanced Medical
Research, Maumee; Eileen Hogan, Albany Medical College, Division of Community
Endocrinology, Albany; Kristen Hook, Heartland Research Associates LLC, Wichita; David
Van Hoornbeek, St. Louis Medical Center for Clinical Research, St. Louis; Morgan Hope,
Radiant Research Inc. - Arizona, Phoenix; Barbara Hopson, Accelovance, Melbourne; Joan
Horner, Wenatchee Valley Hospital and Clinics, Wenatchee; Catherine Horobetz, University
Of Tennessee, Memphis; Patricia Houser, Amherst Family Practice, Winchester; Wynn Htun,
Tulane University Health Sciences Center, New Orleans; Tina Hudson, DCOL Center for
Clinical Research, Longview; Bobbi Huerta, Clinical Study Center Of Asheville LLC, Asheville;
Sulmarur Huizar, Facey Medical Foundation, Mission Hills; Maggi Hullett, Carolina Health
Specialists, Myrtle Beach; Kimberly Hummer, Harold Hamm Diabetes Ctr at the Univ of
Oklahoma, Oklahoma City; Seol Young Hwang, Gotham Cardiovascular Research, PC, New
York; William Ingram, ActivMed Practice & Research, Methuen; Michelle Ingram, University
Of Nebraska Medical Center, Omaha; Faramarz Ismail-Beigi, University Hospitals of
Cleveland Case Medical Center, Cleveland; Leslie Iverson, Radiant Research Inc. - Arizona,
Phoenix; Tamara Jackson, L-MARC Research Center, Louisville; Timothy Jackson, Heritage
Valley Medical Group, Beaver; Richard Jackson, Dominion Medical Associates, Richmond;
Jeffrey Jacqmein, Jacksonville Center For Clinical Research, Jacksonville; Curtis Jantzi,
Holston Medical Group, Kingsport; Isabelle Joffrion, Univ of AL Preventive Medicine,
Birmingham; Jennifer St. John, Harold Hamm Diabetes Ctr at the Univ of Oklahoma,
Oklahoma City; Mandi Johnson, AM Diabetes And Endocrinology Center, Bartlett; Sheri
Jones, Advanced Medical Research, Maumee; Mario Juarez, Panacea Clinical Research, San
Antonio; Tricia Juergens, Selma Medical Associates, Winchester; Sandra Jutras, ActivMed
Practice & Research, Methuen; Angela Kain, Robley Rex VA Medical Center, Louisville;
Christos Kapogiannis, Infinity Medical Research, North Dartmouth; Laure Kassem, University
Hospitals of Cleveland Case Medical Center, Cleveland; Steven Kaster, Wenatchee Valley
Hospital and Clinics, Wenatchee; Bonnie Katalenich, Tulane University Health Sciences
Center, New Orleans; Ashley Kawa, University Hospitals of Cleveland Case Medical Center,
Cleveland; Sarah Keiran, L-MARC Research Center, Louisville; Michele Ketchum, Infinity
Medical Research, North Dartmouth; Janet Keuchel, Diabetes & Endocrine Associates PC,
Omaha; Poonam Khadka, Dartmouth-Hitchcock Medical Center, Lebanon; Nidaa Khamousia,
Advanced Medical Research, Maumee; Khaleda Khan, American Institute of Research, Los
Angeles; Amna Khan, Tulane University Health Sciences Center, New Orleans; Jaber Khan,
Asheboro Research Associates, Asheboro; Janet Kiester, Optimal Research, LLC, Mishawaka;
Grace Kim, Facey Medical Foundation, Mission Hills; Murray Kimmel, Accelovance,
Melbourne; Kara King, L-MARC Research Center, Louisville; Marian Sue Kirkman, University

19 
 
of North Carolina, UNC Diabetes Care Center, Chapel Hill; Wendy Kniffen, Dallas Diabetes &
Endocrine Center, Dallas; Timothy Koehler, Heartland Research Associates LLC, Wichita;
Sarah Konigsberg, Diabetes & Endocrine Associates PC, Omaha; Michael Koren, Jacksonville
Center For Clinical Research, Jacksonville; Irwin Korngut, Radiant Research Inc. - Dallas,
Dallas; Sathya Krishnasamy, Robley Rex VA Medical Center, Louisville; Kevin Kuettel,
Anaheim Clinical Trials, LLC, Anaheim; Tanya Kulow, University Hospitals of Cleveland Case
Medical Center, Cleveland; Mariananda Kumar, Nature Coast Clinical Research - Crystal
River, Crystal River; Swarooparani Kumar, Nature Coast Clinical Research - Crystal River,
Crystal River; Edward Kunst, Mercy Health Research, St. Louis; Raymond Kwan, Pangtay
Research Corporation, MSCI, Irving; Elise Kwon, Facey Medical Foundation, Mission Hills;
Lauren LaBryer, Harold Hamm Diabetes Ctr at the Univ of Oklahoma, Oklahoma City; Alison
Laliberte, Southern New Hampshire Diabetes and Endocrinology, Nashua; T. Lane, Wake
Research Associates, Raleigh; James Lane, Harold Hamm Diabetes Ctr at the Univ of
Oklahoma, Oklahoma City; Jaqueline Lang, Clinical Study Center Of Asheville LLC, Asheville;
Joseph Largay, University of North Carolina, UNC Diabetes Care Center, Chapel Hill; Patricia
Larrabee, Rochester Clinical Research, Inc., Rochester; David Larsen, Wasatch Clinical
Research, Salt Lake City; Kashif Latif, AM Diabetes And Endocrinology Center, Bartlett;
Brandi Lattinville, Nature Coast Clinical Research - Crystal River, Crystal River; Jereta
Lawrence, Arthritis And Diabetes Clinic, Inc., Monroe; Molly Leonard, University of Colorado
Denver, Aurora; Katie Leonard, Meridien Research, Brooksville; Cora Lewis, Univ of AL
Preventive Medicine, Birmingham; Melissa Lewis, Physician's East Endocrinology, Greenville;
Deborah Licklider, Amherst Family Practice, Winchester; Jonea Lim, Harold Hamm Diabetes
Ctr at the Univ of Oklahoma, Oklahoma City; Ildiko Lingvay, UT Southwestern Medical
Center at Dallas, Dallas; Janie Lipps, Diabetes and Obesity Clinical Trials Center, Nashville;
Svetlana Lisovskiy, NorCal Endocrinology and Internal Medicine, San Ramon; Mon Hsia Liu,
Gotham Cardiovascular Research, PC, New York; Yolanda Livingston, Mountain View Clinical
Research Inc, Greer; Shannon Lloyd, St Johns Center For Clinical Research, Ponte Vedra;
Amanda Loeck, Radiant Research Inc. - Arizona, Phoenix; Ryan Loesch, University of
Colorado Denver, Aurora; Lina Lopez, Mountain View Clinical Research Inc, Greer; Maria
Loreto, Sterling Research Group, Ltd., Cincinnati; Dragana Lovre, Tulane University Health
Sciences Center, New Orleans; Peter Lu, Physician Research Associates, LLC, Lawrenceville;
Kimberley Lucas, Asheboro Research Associates, Asheboro; Gabriela Luevano, American
Institute of Research, Los Angeles; Blanca Luna, Stanley F. Stockhammer, Jr. D.O. P.A.,
Deland; Janet Lung, Sterling Research Group, Ltd., Cincinnati; Mabel De La Luz, Facey
Medical Foundation, Mission Hills; Michael Lynch, Facey Medical Foundation, Mission Hills;
Timothy Lyons, Harold Hamm Diabetes Ctr at the Univ of Oklahoma, Oklahoma City; Debra
Mack, Physicians Research Center LLC, Toms River; Robert Madder, Heritage Valley Medical
Group, Beaver; James Magee, East Coast Institute for Research, LLC, Jacksonville; Aparna
Mahakala, Physician Research Associates, LLC, Lawrenceville; Hiralal Maheshwari, Midwest
CRC, Crystal Lake; Michelle Mallitz, Meridien Research, Bradenton; Barabara Maluchnik,
Jacksonville Center For Clinical Research, Jacksonville; Stacie Malyszko, Meridien Research,
Brooksville; Anastasios Manessis, Gotham Cardiovascular Research, PC, New York; Kara
Mann, Dallas Diabetes & Endocrine Center, Dallas; Annis Marney, University of Vermont
Medical Center, South Burlington; Lisa Marshall, Southern New Hampshire Diabetes and
Endocrinology, Nashua; Steven Marso, Saint Luke's Lipid and Diabetes Research Center,
Kansas City; Melissa Martin, Achieve Clinical Research LLC, Birmingham; Kelli Maw, Meridien

20 
 
Research, Brooksville; Michael May, Diabetes and Obesity Clinical Trials Center, Nashville;
Ronald Mayfield, Mountain View Clinical Research Inc, Greer; Ghazala Mazhar, University Of
Tennessee, Memphis; Caroline Mbogua, Carl R. Meisner Medical Clinic, PLLC, Sugarland;
Michael McCartney, ActivMed Practice & Research, Methuen; Roberta McDuffie, Tulane
University Health Sciences Center, New Orleans; Chi McKendall-Lewis, Tulane University
Health Sciences Center, New Orleans; Leanna McKenzie, Meridien Research, Bradenton; Kim
McKibben, Naidu Clinic, Odessa; Rebecca McNair, Achieve Clinical Research LLC,
Birmingham; Praful Mehta, Heartland Research Associates LLC, Wichita; Carl Meisner, Carl
R. Meisner Medical Clinic, PLLC, Sugarland; Nidia Melchor, American Institute of Research,
Los Angeles; Curtis Mello, Infinity Medical Research, North Dartmouth; Melissa Meredith,
University Of Wisconsin-Madison, Madison; Donna Michael, Heritage Valley Medical Group,
Beaver; Gezina Micklewright, L-MARC Research Center, Louisville; Catherine Midyett,
Arthritis And Diabetes Clinic, Inc., Monroe; Jennifer Miller, Jacksonville Center For Clinical
Research, Jacksonville; Alan Miller, Alta Pharmaceutical Research Center, Inc., Dunwoody;
Todd Miller, Alta Pharmaceutical Research Center, Inc., Dunwoody; Neil Miller, Chase
Medical Research LLC, Waterbury; Kari Miller, Radiant Research Inc. - Arizona, Phoenix;
Dawnmarie Minyon-Sarver, Primary Care Research South, Inc, McMurray; Saritha
Mittadodla, Harold Hamm Diabetes Ctr at the Univ of Oklahoma, Oklahoma City; Jennifer
Moeller, University Of Nebraska Medical Center, Omaha; Adrian Mohammadbhoy, Nature
Coast Clinical Research - Crystal River, Crystal River; Sri Mokshagundam, Robley Rex VA
Medical Center, Louisville; Morgan Moloughney, Radiant Research Inc. - Arizona, Phoenix;
Susan Monaco, Anaheim Clinical Trials, LLC, Anaheim; Charles Montgomery, Jacksonville
Center For Clinical Research, Jacksonville; Kelly Moody, Clinical Study Center Of Asheville
LLC, Asheville; Julie Mooney, Rochester Clinical Research, Inc., Rochester; Melanie Moore,
L-MARC Research Center, Louisville; Emily Morawski, Holston Medical Group, Kingsport;
Cynthia Moreau, Tulane University Health Sciences Center, New Orleans; Demetra Morekas,
Accelovance, Melbourne; David Morin, Holston Medical Group, Kingsport; Theresa Mueller,
Clinical Investigations Of Texas, Plano; Denise Muir, Radiant Research Inc. - Arizona,
Phoenix; Julie Mullen, Sterling Research Group, Ltd., Cincinnati; Daniel Murak, Southgate
Medical Group, LLP, West Seneca; Bahar Naderi, Facey Medical Foundation, Mission Hills;
Jayaram Naidu, Naidu Clinic, Odessa; Ikeadi Ndukwu, La Porte County Institute For Clinical
Research, Michigan City; Lauren Nelson, Wake Research Associates, Raleigh; Laura Nelson,
Mercy Health Research, St. Louis; Claretha Nelson, Dominion Medical Associates, Richmond;
Cari Neuberger, Heartland Research Associates LLC, Wichita; Amy Neumeister, University Of
Nebraska Medical Center, Omaha; Melissa Nichols, Achieve Clinical Research LLC,
Birmingham; Natalie Nickerson, Radiant Research Inc. - Arizona, Phoenix; Nikki Nockerts, L-
MARC Research Center, Louisville; Heather O'Brien, Physician's East Endocrinology,
Greenville; Wendy Oden, DCOL Center for Clinical Research, Longview; Philip O'Donnell,
Selma Medical Associates, Winchester; Adeniyi Odugbesan, Physician Research Associates,
LLC, Lawrenceville; Rachel Oiknine, Diabetes And Endocrinology Specialists Inc.,
Chesterfield; Tansy Olio, Wake Research Associates, Raleigh; Michael Oliver, Heritage Valley
Medical Group, Beaver; Carly Olmeda, Tulane University Health Sciences Center, New
Orleans; Sharon Olsen, Facey Medical Foundation, Mission Hills; Christine O'Neil, Southern
New Hampshire Diabetes and Endocrinology, Nashua; Tania Ortega, American Institute of
Research, Los Angeles; Phillip Ostrowski, Southgate Medical Group, LLP, West Seneca;
Kenneth Otah, Oxford Clinical Research, LLC, Houston; Heydin Otero, Clinical Study Center

21 
 
Of Asheville LLC, Asheville; Kevin Packard, Borgess Diabetes and Endocrine Center,
Kalamazoo; Karolynn Painter, Achieve Clinical Research LLC, Birmingham; Dennis Pangtay,
Pangtay Research Corporation, MSCI, Irving; Sonia Pangtay, Pangtay Research Corporation,
MSCI, Irving; Olivia Papacostea, UT Southwestern Medical Center at Dallas, Dallas; Nancy
Papierniak, Renstar Medical Research, Ocala; Anna Parker, Anaheim Clinical Trials, LLC,
Anaheim; Aileen Pascal, Valley Clinical Trials, Northridge; Aileen Pascal-Doriguzzi, First
Valley Medical Group, Lancaster; Alpa Patel, Jacksonville Center For Clinical Research,
Jacksonville; Christine Patel, University Hospitals of Cleveland Case Medical Center,
Cleveland; Minesh Patel, La Porte County Institute For Clinical Research, Michigan City;
Bhadresh Patel, Nature Coast Clinical Research - Crystal River, Crystal River; Mark
Patterson, Renstar Medical Research, Ocala; Carolyn Paulus, Physician Research Associates,
LLC, Lawrenceville; Michelle Peek, Optimal Research, San Diego; Ashley Pegg, Clinical Study
Center Of Asheville LLC, Asheville; Spencer Phelps, Albany Medical College, Division of
Community Endocrinology, Albany; Bunny Phillips, Mountain View Clinical Research Inc,
Greer; Jeanne Piccola, Sterling Research Group, Ltd., Cincinnati; Alicia Pickett, University
Hospitals of Cleveland Case Medical Center, Cleveland; Gloria Pinero, Wake Research
Associates, Raleigh; Angella Pitts, Renstar Medical Research, Ocala; Jonathan Platt, Chase
Medical Research LLC, Waterbury; Madhuri Poduri, UT Southwestern Medical Center at
Dallas, Dallas; Jennifer Poehls, University Of Wisconsin-Madison, Madison; Gaston Ponte,
MIMA Century Research Associates, Melbourne; Laurentiu Pop, UT Southwestern Medical
Center at Dallas, Dallas; Elisabeth Power, Rochester Clinical Research, Inc., Rochester;
Evelyn Price, Panacea Clinical Research, San Antonio; Diane Priest, Harold Hamm Diabetes
Ctr at the Univ of Oklahoma, Oklahoma City; Mark Quadrel, Internal Medicine Of Morris
County, Mine Hill; Rosylen Quinney, Achieve Clinical Research LLC, Birmingham; Shahed
Quyyumi, University Physicians Group, Staten Island; Muriel Rabalais, St Johns Center For
Clinical Research, Ponte Vedra; Diane Rabideau, Chase Medical Research LLC, Waterbury;
Jennifer Rahman, Diabetes & Endocrine Associates PC, Omaha; Christina Raidl, Accelovance,
Melbourne; Karina Ramirez, Anaheim Clinical Trials, LLC, Anaheim; Stacy Ramsey,
University of North Carolina, UNC Diabetes Care Center, Chapel Hill; Uma Rangaraj, Arthritis
And Diabetes Clinic, Inc., Monroe; Veitla Rao, Harold Hamm Diabetes Ctr at the Univ of
Oklahoma, Oklahoma City; Brian Rasmussen, Wasatch Clinical Research, Salt Lake City;
Neda Rasouli, University of Colorado Denver, Aurora; Ruth Rauch, Borgess Diabetes and
Endocrine Center, Kalamazoo; Shannon Ray, Whiteville Medical Associates, PA, Whiteville;
Bridget Recker, University Physicians Group, Staten Island; John Redding, Asheboro
Research Associates, Asheboro; Scott Redrick, Nature Coast Clinical Research - Crystal
River, Crystal River; Jordan Reheis, Heartland Research Associates LLC, Wichita; Joseph
Reiling, Founders Research Corporation, Philadelphia; Susan Reiling, Founders Research
Corporation, Philadelphia; Lucy Rems, Anaheim Clinical Trials, LLC, Anaheim; Kristin Rettig,
Pangtay Research Corporation, MSCI, Irving; Jane Reusch, University of Colorado Denver,
Aurora; Michele Reynolds, Radiant Research Inc. - Dallas, Dallas; Cassie Ricci, Harold
Hamm Diabetes Ctr at the Univ of Oklahoma, Oklahoma City; Lucian Rice, Clinical Study
Center Of Asheville LLC, Asheville; Heather Rickard, Mountain View Clinical Research Inc,
Greer; Jessica Rios-Santiago, Coastal Metabolic Research Center, Ventura; Barbara Ritchey,
L-MARC Research Center, Louisville; Sylvia Rivera, Briggs Clinical Research, LLC, San
Antonio; Demetrius Rizos, ActivMed Practice & Research, Methuen; Syed Fahad Rizvi,
Oxford Clinical Research, LLC, Houston; Robert Robbins, Asheboro Research Associates,

22 
 
Asheboro; Dawn Robison, Jacksonville Center For Clinical Research, Jacksonville; Sheri
Rocco, Mercy Health Research, St. Louis; Cathy Roche, Univ of AL Preventive Medicine,
Birmingham; Alfredo Rodes, Southgate Medical Group, LLP, West Seneca; Juan Pablo
Perdomo Rodriguez, University of Vermont Medical Center, South Burlington; Maria
Rodriguez, University Of Nebraska Medical Center, Omaha; Martha Rojas, Anaheim Clinical
Trials, LLC, Anaheim; Norma Rokoff, Accelovance, Melbourne; Christopher Roney, Achieve
Clinical Research LLC, Birmingham; Leslie Rooker-Morris, Dallas Diabetes & Endocrine
Center, Dallas; Connie Root, Diabetes and Obesity Clinical Trials Center, Nashville; Cathy
Roozen, Wenatchee Valley Hospital and Clinics, Wenatchee; Julio Rosenstock, Dallas
Diabetes Research Center, Dallas; Irena Ross, Carolina Health Specialists, Myrtle Beach;
Marilynn Roth, University of Vermont Medical Center, South Burlington; Eli Roth, Sterling
Research Group, Ltd., Cincinnati; Jeffrey Rothman, University Physicians Group, Staten
Island; Miguel Roura, East Coast Institute for Research, LLC, Jacksonville; Kathleen Russell,
University Hospitals of Cleveland Case Medical Center, Cleveland; Emily Russell, Amherst
Family Practice, Winchester; Cheryl Rutherford, Saint Luke's Lipid and Diabetes Research
Center, Kansas City; Jennifer Salazar, Harold Hamm Diabetes Ctr at the Univ of Oklahoma,
Oklahoma City; Jorge Salazar, MIMA Century Research Associates, Melbourne; Rebecca
Sanagorski, University of Colorado Denver, Aurora; Amanda Sandy, Wake Research
Associates, Raleigh; Jose Santiago, MIMA Century Research Associates, Melbourne;
Jacqueline Saunders, Mountain View Clinical Research Inc, Greer; Holli Schmidt, Heartland
Research Associates LLC, Wichita; Christopher Schneider, Borgess Diabetes and Endocrine
Center, Kalamazoo; Erich Schramm, St Johns Center For Clinical Research, Ponte Vedra;
Rashi Schramm, St Johns Center For Clinical Research, Ponte Vedra; Richard
Schultzaberger, Physician's East Endocrinology, Greenville; Laurie Schweppe, Meridien
Research, Bradenton; Laurie Schweppe, Meridien Research, Brooksville; Robert Scott,
Asheboro Research Associates, Asheboro; Anita Scribner, DCOL Center for Clinical Research,
Longview; Theresa Seddon, Amherst Family Practice, Winchester; Jennifer Seekford,
Amherst Family Practice, Winchester; Scott Segel, East Coast Institute for Research, LLC,
Jacksonville; Randall Severance, Radiant Research Inc. - Arizona, Phoenix; Megan
Severson, University Of Nebraska Medical Center, Omaha; Kayur Shah, Facey Medical
Foundation, Mission Hills; Jessica Shaw, Harold Hamm Diabetes Ctr at the Univ of
Oklahoma, Oklahoma City; Marc Shay, ActivMed Practice & Research, Methuen; Michelle
Sheets, La Porte County Institute For Clinical Research, Michigan City; Christina Shelton, L-
MARC Research Center, Louisville; Leslie Shelton, Radiant Research Inc. - Arizona, Phoenix;
Sandra Shelton, Cedar-Crosse Research Center, Chicago; James Shikany, Univ of AL
Preventive Medicine, Birmingham; Jeanette Shippey, Southern New Hampshire Diabetes and
Endocrinology, Nashua; Vijay Shivaswamy, University Of Nebraska Medical Center, Omaha;
Yshay Shlesinger, NorCal Endocrinology and Internal Medicine, San Ramon; Tammi
Shlotzhauser, Rochester Clinical Research, Inc., Rochester; Mindy Shook, DCOL Center for
Clinical Research, Longview; David Shore, Physician Research Associates, LLC,
Lawrenceville; Marina Shvarts, Carolina Health Specialists, Myrtle Beach; Muhammad
Siddiqui, UT Southwestern Medical Center at Dallas, Dallas; Robert Silver, Southern New
Hampshire Diabetes and Endocrinology, Nashua; Henry Simon, Physicians Research Center
LLC, Toms River; Manmeet Singh, Tulane University Health Sciences Center, New Orleans;
Mary Jo Sites, Physicians Research Center LLC, Toms River; Dee Sitton, University Hospitals
of Cleveland Case Medical Center, Cleveland; Kanagaratnam Sivalingam, First Valley Medical

23 
 
Group, Lancaster; Danielle Smith, L-MARC Research Center, Louisville; Kristy Smith,
Mountain View Clinical Research Inc, Greer; Nina Smith, Nature Coast Clinical Research -
Crystal River, Crystal River; Timothy Smith, Mercy Health Research, St. Louis; Jennifer
Smith, Physician's East Endocrinology, Greenville; Janice Snyder, Diabetes & Endocrine
Associates PC, Omaha; Brian Snyder, Southgate Medical Group, LLP, West Seneca; Ajay
Sood, University Hospitals of Cleveland Case Medical Center, Cleveland; Jennifer Soon,
American Institute of Research, Los Angeles; Lynn Sorrentino, Renstar Medical Research,
Ocala; Jennifer Sortor, Advanced Medical Research, Maumee; James Sosnowchik, Achieve
Clinical Research LLC, Birmingham; Joseph Soufer, Chase Medical Research LLC, Waterbury;
Jeni Spears, Radiant Research Inc. - Arizona, Phoenix; Linda Spector, Southern New
Hampshire Diabetes and Endocrinology, Nashua; Richard Speicher, Stanley F.
Stockhammer, Jr. D.O. P.A., Deland; Amy Stacey, DCOL Center for Clinical Research,
Longview; Mollie Stafford, Clinical Study Center Of Asheville LLC, Asheville; Jennifer
Stanford, Selma Medical Associates, Winchester; Martha Stayer, Amherst Family Practice,
Winchester; Carol Stell, Tulane University Health Sciences Center, New Orleans; Elizabeth
Stenger, St. Louis Medical Center for Clinical Research, St. Louis; Stanley Stockhammer,
Stanley F. Stockhammer, Jr. D.O. P.A., Deland; Jill Stoneman, Mercy Health Research, St.
Louis; Donna Straatmann, Mercy Health Research, St. Louis; Danny Sugimoto, Cedar-
Crosse Research Center, Chicago; Michael Sugimoto, Cedar-Crosse Research Center,
Chicago; Farah Sultan, Achieve Clinical Research LLC, Birmingham; Sreenija Suryadevara,
Dartmouth-Hitchcock Medical Center, Lebanon; David Sutton, East Coast Institute for
Research, LLC, Jacksonville; Delores Swan, Clinical Investigation Specialists Inc, Gurnee;
Claude Sy, Southgate Medical Group, LLP, West Seneca; Shellie Talley, Achieve Clinical
Research LLC, Birmingham; Mitali Talsania, Harold Hamm Diabetes Ctr at the Univ of
Oklahoma, Oklahoma City; Anjanette Tan, Diabetes and Thyroid Center of Fort Worth, Fort
Worth; Peggy Taylor, Holston Medical Group, Kingsport; Tina Thethi, Tulane University
Health Sciences Center, New Orleans; Shannon Thomas, Heartland Research Associates
LLC, Wichita; Casey Thompson, Physician's East Endocrinology, Greenville; Anna Thottan,
University of Vermont Medical Center, South Burlington; Margaret Tiktin, University
Hospitals of Cleveland Case Medical Center, Cleveland; Renee Tillson, University Of
Nebraska Medical Center, Omaha; Rebecca Timpe, Borgess Diabetes and Endocrine Center,
Kalamazoo; Irene Tinney, Naidu Clinic, Odessa; Reinaldo Tirado-Bernardini, Accelovance,
Melbourne; Cindy Tobias, St. Louis Medical Center for Clinical Research, St. Louis; Timothy
Tobin, DCOL Center for Clinical Research, Longview; Florence Toe, Carl R. Meisner Medical
Clinic, PLLC, Sugarland; Carole Torello, Chase Medical Research LLC, Waterbury; Amanda
Tousson, University Physicians Group, Staten Island; Jennifer Tousson, University
Physicians Group, Staten Island; Julie Toven, Valley Clinical Trials, Northridge; Carolyn
Tran, Jacksonville Center For Clinical Research, Jacksonville; Constance Trantow, University
Of Wisconsin-Madison, Madison; Stefano Travaglini, East Coast Institute for Research, LLC,
Jacksonville; Henry Traylor, Whiteville Medical Associates, PA, Whiteville; Dawn Tripp,
Rochester Clinical Research, Inc., Rochester; Anna Tumyan, UT Southwestern Medical
Center at Dallas, Dallas; Juliana Turner, Clinical Study Center Of Asheville LLC, Asheville;
Melissa Twine, Prestige Clinical Research, Franklin; Treva Tyson, Wake Research Associates,
Raleigh; Chantal Underkofler, University of Colorado Denver, Aurora; Enyibuaku Uzoaga,
Oxford Clinical Research, LLC, Houston; Vanessa Valdivia, Anaheim Clinical Trials, LLC,
Anaheim; Patricia Valencia, Oxford Clinical Research, LLC, Houston; Michael Valitutto,

24 
 
Borgess Diabetes and Endocrine Center, Kalamazoo; Anna Vanderheiden, UT Southwestern
Medical Center at Dallas, Dallas; Raghupathy Varavenkataraman, Southgate Medical Group,
LLP, West Seneca; David Vickery, Clinical Study Center Of Asheville LLC, Asheville; Shari
Vincent, Wake Research Associates, Raleigh; Khurram Wadud, East Coast Institute for
Research, LLC, Jacksonville; Timothy Wahl, Diabetes & Endocrine Associates PC, Omaha;
Frank Walker, L-MARC Research Center, Louisville; Kimberly Walsh, Dartmouth-Hitchcock
Medical Center, Lebanon; Aileen Wang, Tulane University Health Sciences Center, New
Orleans; Karla Wardell, Physician Research Associates, LLC, Lawrenceville; Mark Warren,
Physician's East Endocrinology, Greenville; Kathleen Weindorff, DCOL Center for Clinical
Research, Longview; Maria Weir, Diabetes And Endocrinology Specialists Inc., Chesterfield;
Albert Weisbrot, Albert J Weisbrot, Mason; Sarah Weiss, Meridien Research, Bradenton;
Kathleen Weiter, L-MARC Research Center, Louisville; Matthew Wenker, Sterling Research
Group, Ltd., Cincinnati; Howard Wenocur, Founders Research Corporation, Philadelphia;
Mary West, Naidu Clinic, Odessa; Elizabeth White, Radiant Research Inc. - Dallas, Dallas;
Judith White, Holston Medical Group, Kingsport; Rebecca Whitehead, L-MARC Research
Center, Louisville; Jessica Whittle, Facey Medical Foundation, Mission Hills; Christine Wigley,
University Of Tennessee, Memphis; Francesca Wilkins, Tulane University Health Sciences
Center, New Orleans; Hayes Williams, Achieve Clinical Research LLC, Birmingham; Megan
Williams, Amherst Family Practice, Winchester; Cathi Williamson, St Johns Center For
Clinical Research, Ponte Vedra; Lou Ellen Wilson, Facey Medical Foundation, Mission Hills;
Sheryl Windsor, Saint Luke's Lipid and Diabetes Research Center, Kansas City; Linder
Wingo, Renstar Medical Research, Ocala; Peter Winkle, Anaheim Clinical Trials, LLC,
Anaheim; Lisa Wishard, Rochester Clinical Research, Inc., Rochester; Shanna Wisneski, La
Porte County Institute For Clinical Research, Michigan City; Melanie Witte, University Of
Wisconsin-Madison, Madison; Lindsay Wolfman, University of Colorado, Aurora; James
Wollet, University Of Wisconsin-Madison, Madison; Ruth Wood, Mountain View Clinical
Research Inc, Greer; Holly Wyatt, University of Colorado, Aurora; Patrick Yassini, Optimal
Research, San Diego; Gary Yeoman, Founders Research Corporation, Philadelphia; Dayna
York, Wake Research Associates, Raleigh; Laura Young, University of North Carolina, UNC
Diabetes Care Center, Chapel Hill; Timothy Young, Wasatch Clinical Research, Salt Lake
City; Joel Zaretzky, Chase Medical Research LLC, Waterbury; Maureen Ziboh, Optimal
Research, LLC, Mishawaka; Erin Zimmer, Renstar Medical Research, Ocala.

25 
 
Additional statistical details

Analysis sets

Full Analysis Set (FAS): includes all randomised patients. The statistical evaluation of the

FAS will follow the intention-to-treat (ITT) principle and patients will contribute to the

evaluation “as randomized”.

Safety Analysis Set (SAS): includes all patients exposed to at least one dose of trial product.

Patients in the SAS will contribute to the evaluation based on the trial product received for

the majority of the period where they were on-treatment. This will be referred to as

contributing to the evaluation “as treated”.

Modified ITT: includes all exposed patients. Patients will contribute to the evaluation “as

randomized”.

Data selection and observation periods

Data for analysis will be selected in a two-step manner. In the first step the analysis set will

be selected. In the second step, information on patients in the analysis set will be selected

according to whether or not it belongs to the given observation period used in the analysis.

Information collected with onset date outside the observation period will be treated as

missing and therefore excluded from the corresponding analysis. Information collected after

the end of the most extensive data collection, the in-trial observation period (see below),

and prior to database lock will be evaluated, adjudicated if applicable and summarized

descriptively.

In this trial, two observation periods will be defined, as described below.

26 
 
In-trial: This observation period represents the time period in which patients are considered

trial participants. It will include information collected at or after date of randomization but

not information collected after the last direct patient-site contact, which is scheduled to take

place 5 weeks after the planned date of last dose of trial product at an end-of-trial follow-up

visit, or the death of the patient during the trial which ever happens first. For patients who

withdraw their informed consent, the in-trial observation period will end at the date of

withdrawal. If a patient is lost to follow-up, the end of his/her in-trial period will be defined

as the date of the last direct patient-site contact (site or phone visit).

On-treatment: This observation period is a subset of the in-trial observation period and

represents information collected while patients are considered exposed to trial product and

will accordingly include the scheduled follow-up period of 5 weeks duration with a visit

window of +7 days after the date of last dose of trial product.

Calculation of time-to-event and censoring

For analyses of time-to-event endpoints, patients who do not experience an event will be

censored at the patient-specific end-dates defined by the observation periods. This implies

that the potential censoring time will be the same across different time-to-event endpoints

within an observation period. Time to event or censoring will be calculated as time from the

randomization date in an analysis based on the in-trial observation period and from the date

of first dose of trial product in an analysis based on the on-treatment observation period.

The patient years of observation time used in e.g. the calculation of adverse event rates will

be calculated as the difference between start-date and end-date (both included) of the

observation period used in the given analysis.

27 
 
Analyses of time to event endpoints

The primary analysis was based on FAS using the in-trial observation period. The primary

endpoint was analyzed using a stratified Cox proportional hazards model with treatment

group (semaglutide, placebo) as fixed factor. The model was stratified by all possible

combinations of the three stratification factors used in the randomization procedure (in total

9 levels). From this model the estimated hazard ratio (HR) (semaglutide/placebo) together

with the two-sided 95% confidence interval (CI) was derived. Non-inferiority of semaglutide

versus placebo will be considered confirmed if the upper limit of the two-sided 95% CI for

the hazard ratio is below 1.8 or equivalent if the P value for the one-sided test of

H0: HR >=1.8 against Ha: HR <1.8

is less than 2.5% (or equivalent to 5% for a two-sided test)

The analyses for other time to event endpoints were similar Cox regressions. For these

confidence intervals and P values for null-hypotheses of no-difference (two-sided with 5%

significance level) with no adjustment for multiplicity were calculated.

The time to event analyses of the sub-components of non-fatal myocardial, non-fatal stroke,

revascularization, retinopathy and nephropathy were specified post-hoc. For these an un-

stratified Cox proportional hazards model with treatment group (semaglutide, placebo) as

fixed factor was applied.

Analyses of continuous efficacy and safety endpoints

Continuous efficacy and safety endpoints were analyzed by separate mixed models for

repeated measurements using all post-baseline scheduled visit data irrespective of

premature treatment discontinuation adjusted for treatment (4 levels: semaglutide 0.5 mg,

semaglutide 1.0 mg, placebo 0.5 mg and placebo 1.0 mg), stratification and baseline value,

28 
 
all nested within visit. From the model, pairwise comparisons between volume matched

semaglutide and placebo were conducted (semaglutide 1.0 mg vs placebo 1.0 mg and

semaglutide 0.5 mg vs semaglutide 1.0 mg).

For efficacy, the analyses were based on the full analysis set with all in-trial data. For safety

the analyses were based on the safety analysis set with on-treatment data.

Analyses of hypoglycemia

The number of hypoglycemia (all and noncturnal) were analyzed using separate negative

binomial regression models with a log-link function and the logarithm of the observation

time defined by the in-trial observation period as off-set. The model included treatment

(four levels: semaglutide 0.5 mg, semaglutide 1.0 mg, placebo 0.5 mg and placebo 1.0 mg)

and stratification (9 levels) as fixed factors and baseline HbA1c as covariate.

The number of patients experiencing hypoglycemia (all and nocturnal) were analyzed using

separate logistic regression models with treatment (four levels: semaglutide 0.5 mg,

semaglutide 1.0 mg, placebo 0.5 mg and placebo 1.0 mg) and stratification (9 levels) as

fixed factors and baseline HbA1c as covariate.

Neoplasm Cox regression analysis

Post-hoc analyses of time to first occurrence of EAC-confirmed neoplasm were conducted for

all neoplasms, all benign neoplasms, all pre-malignant/carcinoma in situ/borderline

neoplasms and malignant neoplasms by system of origin. These post-hoc endpoints were

analyzed using an unstratified Cox proportional hazards model with treatment group

(semaglutide, placebo) as fixed factor. The models were based on the full analysis set using

the in-trial observation period. From the models the estimated hazard ratios (HR)

(semaglutide/placebo) together the two-sided 95% confidence intervals (CI) were derived.

29 
 
Sensitivity analyses for primary endpoint

To explore the robustness of the primary analysis results the following sensitivity analyses

will be pre-specified.

Sensitivity analysis 1:

This sensitivity analysis will analyse the primary outcome including all EAC-confirmed

MACEs that are collected while patients are considered to be exposed to trial product.

Specifically, the primary analysis will be repeated based on the SAS using the on-treatment

observation period (i.e. with an ascertainment window of 42 days).

Sensitivity analysis 2:

Sensitivity analysis 1 will be repeated with an ascertainment window of 7 days instead of

the 42 days specified for the on-treatment observation period.

Sensitivity analysis 3:

Sensitivity analysis 1 will be repeated with an ascertainment window of 30 days instead of

the 42 days specified for the on-treatment observation period.

Sensitivity analysis 4:

This sensitivity analysis will be a modified ITT analysis where exposed patients from FAS

contribute to the evaluation as randomized. It will include EAC-confirmed MACEs from the

on-treatment observation period (i.e. with an ascertainment window of 42 days).

Sensitivity analysis 5:

Sensitivity analysis 4 will be repeated with an ascertainment window of 7 days instead of

the 42 days specified for the on-treatment observation period.

30 
 
Sensitivity analysis 6:

Sensitivity analysis 4 will be repeated with an ascertainment window of 30 days instead of

the 42 days specified for the on-treatment observation period.

Sensitivity analysis 7:

This sensitivity analysis will investigate the impact of stratification. The primary outcome

will be analyzed using an unstratified Cox proportional hazards model with treatment group

(semaglutide, placebo) as fixed factor. This analysis will, like the primary analysis, be based

on FAS using the in-trial observation period.

Sensitivity analysis 8:

Based on feedback from FDA the time limit for an acute coronary or cerebrovascular event

prior to randomization was changed from 14 to 90 days in Global Protocol Amendment no. 4

– May 2013. The rationale for this change is that patients who have experienced a recent

CV event are likely to experience another event within the first months following the initial

CV event and these events should not be attributed to treatment. Accordingly, in this

sensitivity analysis the primary analysis will be repeated based on the FAS using the in-trial

observation period where patients experiencing an acute coronary or cerebrovascular event

within 90 days prior to randomization will be excluded.

Sensitivity analysis 9:

This sensitivity analysis investigates the consistency in the treatment effect for the primary

outcome across the two dose levels. The primary outcome will be analyzed using a stratified

Cox proportional hazards model with treatment group (four levels: 0.5 mg semaglutide, 1.0

mg semaglutide, 0.5 mg semaglutide placebo, 1.0 mg semaglutide placebo) as fixed factor.

The model will be stratified by all possible combinations of the three stratification factors

31 
 
used in the randomization procedure (in total 9 levels). From this model the estimated

hazard ratios for (0.5 mg semaglutide/0.5 mg semaglutide placebo) and (1.0 mg

semaglutide/1.0 mg semaglutide placebo) together with the corresponding 2-sided 95% CIs

will be presented. This analysis will, like the primary analysis, be based on FAS using the in-

trial observation period.

Two additional per-protocol sensitivity analyses were specified post-hoc:

Sensitivity analysis 10:

This sensitivity analysis investigates the consistency in the treatment effect for a per-

protocol analysis set defined by exposed patients who complete trial and either do not

discontinue treatment prematurely, or who are exposed for at least 1 year. The primary

outcome will be analysed using an unstratified Cox proportional hazards model with

treatment group (semaglutide, placebo) as fixed factor. This analysis will be based on the

on-treatment observation period.

Sensitivity analysis 11:

The above per-protocol analysis was repeated for the in-trial observation period.

Exploratory subgroup analysis of the primary outcome

The consistency in the treatment effect for the primary outcome will be explored separately

by the below defined subgroups based on baseline information:

 Sex

 Age: <65 years or ≥65 years

 Body mass index (BMI): ≤30 kg/m2 or >30 kg/m2

32 
 
  HbA1c: ≤8.5% or >8.5%

 Duration of diabetes: ≤10 years or >10 years

 Region defined as

o EU (Bulgaria, Denmark, Germany, Italy, Poland, Spain, UK)

o USA

o Rest of the World (Algeria, Argentina, Australia, Brazil, Canada, Israel,

Malaysia, Mexico, Russian Federation, Thailand, Taiwan, Turkey)

 Race defined as White, Black or African-American, Asian, or ‘Other’

 Ethnicity defined as Hispanic or Latino (Yes or No)

 Chronic heart failure New York Heart Association (NYHA) class II–III (Yes or No)

 Cardiovascular disease status (established or risk factors) (stratification factor)

 Insulin treatment (none, basal insulin or pre-mixed insulin) (stratification factor)

 Severe renal impairment with GFR value <30 ml/min/1.73m2 per MDRD (Yes or No)

(stratification factor)

 Severe or moderate renal impairment with GFR value <60 ml/min/1.73m2 per MDRD

(Yes or No)

 Severe renal impairment with GFR value <30 ml/min/1.73m2 per Chronic Kidney

Disease Epidemiology Collaboration (CKD-EPI) (Yes or No)

 Severe or moderate renal impairment with GFR value <60 ml/min/1.73m2 per CKD-

EPI (Yes or No)

 Myocardial infarction or stroke prior to randomization (Yes or No)

All subgroup analyses were pre-specified with the exception of myocardial infarction or

stroke prior to randomization.

33 
 
The sub-group analyses will be based on the FAS using the in-trial observation period. For

each subgroup analysis the primary outcome will be analyzed using an unstratified Cox

proportional hazards model with an interaction between treatment group (semaglutide,

placebo) and the relevant subgroup as fixed factor. From this model the estimated hazard

ratios for (semaglutide/placebo) together with corresponding 2-sided 95% CIs for each

subgroup level will be presented. A forest plot showing the estimated hazard ratios and 95%

CIs by each subgroup level will be presented to explore the consistency of the primary

analysis results across subgroup levels together with a P value for an interaction effect.

Analyses of antihyperglycemic and cardiovascular medication

Post-hoc analyses of binary endpoints for use of antihyperglycemic and cardiovascular

medication at baseline as well as for introduction during trial (with duration of at least 21

days for antihyperglycaemic medication) were conducted for selected groups of medication.

For antihyperglycemic medication the statistical model was a logistic regression with

treatment (four levels: semaglutide 0.5 mg, semaglutide 1.0 mg, placebo 0.5 mg and

placebo 1.0 mg) and stratification (9 levels) as fixed factors and baseline HbA1c as

covariate. For cardiovascular medication the statistical model was a logistic regression with

treatment (four levels: semaglutide 0.5 mg, semaglutide 1.0 mg, placebo 0.5 mg and

placebo 1.0 mg) and stratification (9 levels) as fixed factors

34 
 
Figure S1A. Patient Disposition

Trial completers are defined as patients that either attend the last follow-up visit or who die during trial. FAS denotes full

analysis set.

35 
 
Figure S1B. Reasons for Patients Being Excluded or Leaving the Trial Before Randomization

Reasons for screening failures Number of

patients
(A full list of inclusion and exclusion criteria are provided in Supplementary Table S2)

Total 1049

Inclusion criteria 1: Informed consent obtained before any trial-related activities. Trial-related activities are 8

any procedures that are carried out as part of the trial, including activities to determine suitability for the

trial

Inclusion criteria 3: Age ≥50 years at screening and clinical evidence of cardiovascular disease defined as 86

meeting at least one of the criteria defined in Table S1

Inclusion criteria 4: Antidiabetic drug naive, or treated with one or two OAD(s), or treated with human NPH 8

insulin or long-acting insulin analogue or pre-mixed insulin, alone or in combination with one or two

OAD(s)

Inclusion criteria 5: HbA1c ≥7.0% at screening 668

Exclusion criteria 2: Use of GLP-1 receptor agonist (exenatide [BID or OW], liraglutide, or other) or 2

pramlintide within 90 days prior to screening

36 
 
 Exclusion criteria 3: Use of any DPP-4 inhibitor within 30 days prior to screening 16

Exclusion criteria 4: Treatment with insulin other than basal and pre-mixed insulin, within 90 days prior to 14

screening - except for short-term use in connection with intercurrent illness

Exclusion criteria 5: Acute decompensation of glycaemic control requiring immediate intensification of 2

treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to

screening

Exclusion criteria 6: History of chronic pancreatitis or idiopathic acute pancreatitis 3

Exclusion criteria 7: An acute coronary or cerebro-vascular event within the previous 14 days from visit 2 16

Exclusion criteria 8: Currently planned coronary, carotid or peripheral artery revascularization 4

Exclusion criteria 9: Chronic Heart Failure NYHA Class IV 1

Exclusion criteria 11: End-stage liver disease, defined as the presence of acute or chronic liver disease and 2

recent history of one or more of the following: ascites, encephalopathy, variceal bleeding, bilirubin ≥2.0

mg/dL, albumin level ≤3.5 g/dL, prothrombin time ≥4 seconds prolonged, international normalised ratio

(INR) ≥1.7 or prior liver transplant

Exclusion criteria 13: Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy 20

in the previous 5 years

37 
 
 Exclusion criteria 16: Calcitonin ≥50 ng/l at screening 12

Exclusion criteria 17: Any acute condition or exacerbation of chronic condition that would in the 14

investigator's opinion interfere with the initial trial visit schedule and procedures

Exclusion criteria 19: Known use of non-prescribed narcotics or illicit drugs 1

Exclusion criteria 21: Simultaneous participation in any other clinical trial of an investigational agent. 4

Participation in a clinical trial with investigational stent(s) is allowed

Exclusion criteria 23: Any other factor likely to limit protocol compliance or reporting of AE at the discretion 53

of the investigator

Exclusion criteria 24: Female of childbearing potential who is pregnant, breast-feeding or intend to 3

become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures as

required by local law)

Other 151

38 
 
Figure S2. Forest Plot Showing Sensitivity Analyses for the Primary Outcome

FAS, full analysis set; ITT, intention-to-treat; SAS, safety analysis set. Hazard ratios are estimated using Cox proportional-

hazards models with treatment (semaglutide, placebo) as a fixed factor. The sensitivity analyses used alternative patient

39 
 
selection and censoring strategies for exposure to treatment. No patients changed from active to placebo or vice versa,

resulting in identical sensitivity analyses for the modified ITT as for the safety analysis set. Per-protocol sensitivity analyses

were specified post-hoc.

40 
 
Figure S3. Forest Plot Showing Subgroup Analyses for the Primary Outcome

BMI, Body Mass Index; CI, confidence interval; HbA1c, glycated hemoglobin; eGFR,

estimated glomerular filtration rate; MDRD, Modification of Diet in Renal Disease; MI,

41 
 
myocardial infarction. All subgroup analyses shown were pre-specified with the exception of

prior MI or prior stroke. Hazard ratios and P values are estimated using Cox proportional-

hazards models with an interaction between treatment group (semaglutide, placebo) and

the relevant subgroup as fixed factor. The P values are for test of the interaction effect with

no adjustment for multiplicity.

42 
 
Figure S4. Cardiovascular Outcomes by Individual Treatment Group

Kaplan—Meier plots showing primary outcome (Panel A), Non-fatal myocardial infarction (Panel B), Non-fatal stroke (Panel C)

and Cardiovascular death (Panel D)

A. Primary outcome

43 
 
B. Non-fatal myocardial infarction

44 
 
C. Non-fatal stroke

   

45 
 
D. Cardiovascular death 

46 
 
Figure S5. Microvascular Outcomes

Kaplan—Meier plots showing time to first diabetic retinopathy complications (Panel A) and new or worsening

nephropathy (Panel B)

A. Diabetic retinopathy complications 

47 
 
B. New or worsening nephropathy

48 
 
Figure S6. Changes in Mean Systolic (Panel A) and Diastolic (Panel B) Blood Pressure Over Time

A. Systolic blood pressure

49 
 
B. Diastolic blood pressure

     

50 
 
Figure S7. Changes in Mean Lipase (Panel A) and Amylase (Panel B) Over Time

A. Lipase

51 
 
B. Amylase

52 
 
Data are estimated mean plus or minus standard error of the mean based on in-trial data for scheduled visits for the full

analysis set, analyzed by a mixed model for repeated measures with treatment group (four levels: 0.5 mg semaglutide, 1.0 mg

semaglutide, 0.5 mg semaglutide placebo, 1.0 mg semaglutide placebo) and stratification (9 levels) as fixed factors and the

corresponding baseline value as a covariate, all nested within visit. Lipase and amylase were analyzed on log-scale.

For lipase, the upper limit of normal (ULN) was 63 U/L; for amylase, ULN was 100 U/L. There were 63.8% and 48.1% of

semaglutide- and placebo-treated patients who at some point during the trial had a lipase greater than or equal to the ULN.

Similarly, for amylase there were 39.3% and 31.6%, respectively. There were 12.7% and 9.1% of semaglutide- and placebo-

treated patients who at some point during the trial had a lipase greater than or equal to 3 times ULN. Similarly, for amylase

there were 1.6% and 0.9%, respectively.

   

53 
 
Figure S8. Neoplasms: Total and Malignant by Organ of Origin

  

All events were event adjudication committee-confirmed. CNS, central nervous system. Hazard ratios are estimated using a Cox

proportional-hazards model with treatment (semaglutide, placebo) as a fixed factor.

54 
 
Table S1. Eligible Patients: Criteria for Established Cardiovascular Disease and Risk Factors

Aged 50 years or older with Aged 60 years or older with subclinical

documented clinical evidence of evidence of cardiovascular disease

cardiovascular disease (established (cardiovascular risk factors)*

cardiovascular disease)*

Defined as meeting at least one of the Defined as meeting at least one of the below

below criteria: criteria:

 prior myocardial infarction  persistent microalbuminuria (30‒299

 prior stroke or prior transient mg/g) or proteinuria

ischemic attack  hypertension and left ventricular

 prior coronary, carotid or peripheral hypertrophy by electrocardiogram or

arterial revascularization imaging

 more than 50% stenosis on  left ventricular systolic or diastolic

angiography or imaging of coronary, dysfunction by imaging

carotid or lower extremities arteries  ankle/brachial index less than 0.9

 history of symptomatic coronary

heart disease documented by e.g.

positive exercise stress test or any

cardiac imaging or unstable angina

with ECG changes

 asymptomatic cardiac ischemia

documented by positive nuclear

imaging test or exercise test or

stress echo or any cardiac imaging

 chronic heart failure New York Heart

Association (NYHA) class II-III

55 
 
  chronic renal impairment,

documented (prior to screening) by

estimated glomerular filtration rate

below

60 ml/min/1.73 m2 per MDRD

MDRD, modification of diet in renal disease

*
As determined by the investigator.

56 
 
Table S2. List of Inclusion and Exclusion Criteria

Key inclusion criteria

 Men and women with type 2 diabetes

 Age ≥50 years at screening and clinical evidence of cardiovascular disease

(established cardiovascular disease) or age ≥60 years at screening and

subclinical evidence of cardiovascular disease (cardiovascular risk factors; see

Table S1)

 Antidiabetic drug naïve, or treated with one or two oral antidiabetic drug(s), or

treated with human Neutral Protamine Hagedorn (NPH) insulin or long-acting

insulin analogue or pre-mixed insulin, both types of insulin either alone or in

combination with one or two oral antidiabetic drug(s)

 HbA1c ≥7.0% at screening

Key exclusion criteria

 Type 1 diabetes

 Use of other glucagon-like peptide-1 receptor agonist or pramlintide within 90

days prior to screening

 Use of any dipeptidyl peptidase-4 inhibitor within 30 days prior to screening

 Treatment with insulin, other than basal and pre-mixed insulin, within 90 days

prior to screening (except for short-term use)

 Acute decompensation of glycemic control requiring immediate intensification of

treatment to prevent acute complications of diabetes (e.g. diabetes

ketoacidosis) within 90 days prior to screening

 History of chronic pancreatitis or idiopathic acute pancreatitis

 Acute coronary or cerebrovascular event within 90 days prior to randomization

 Currently planned coronary, carotid or peripheral artery revascularization

57 
 
  Chronic heart failure New York Heart Association class IV

 Chronic hemodialysis or chronic peritoneal dialysis

 End-stage liver disease, defined as the presence of acute or chronic liver

disease and recent history of one or more of the following: ascites,

encephalopathy, variceal bleeding, bilirubin ≥2.0 mg/dl, albumin level ≤3.5

g/dl, prothrombin time ≥4 seconds prolonged, international normalized ratio

≥1.7 or prior liver transplant

 A prior solid organ transplant or awaiting solid organ transplant

 Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin

cancer or squamous cell skin cancer)

 Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or

familial medullary thyroid carcinoma

 Personal history of non-familial medullary thyroid carcinoma

 Screening calcitonin ≥50 ng/l

 Any acute condition or exacerbation of chronic condition that would in the

investigator's

 opinion interfere with the initial trial visit schedule and procedures

 Known or suspected hypersensitivity to trial products or related products

 Known use of non-prescribed narcotics or illicit drugs

 Previous participation in this trial. Participation is defined as randomized

 Simultaneous participation in any other clinical trial of an investigational agent.

Participation in a clinical trial with investigational stent(s) is allowed

 Receipt of any investigational medicinal product within 30 days prior to

screening (Visit 1) or according to local requirements, if longer

58 
 
  Brazil: receipt of any investigational drug within one year prior to screening

visit (Visit 1), unless there is a direct benefit to the research patient at the

investigator’s discretion

 Any other factor likely to limit protocol compliance or reporting of adverse event

at the discretion of the investigator

 Female of childbearing potential who is pregnant, breast-feeding or intends to

become pregnant or is not using an adequate contraceptive method (adequate

contraceptive measure as required by local regulation or practice)

59 
 
Table S3. Glycemic Control in SUSTAIN 6

Actions taken to ensure optimal glycemic control in SUSTAIN 6

 Global newsletter to all sites including blood glucose treatment guidelines (June
2013)a

 Treatment guidancea re-distributed to all Investigators (Dec 2014)

 Global letters distributed to all Investigators (May 2015, Nov 2015)

 Direct contact with sites on patients with inadequate glycemic control (Dec 2014)

 Action for National Investigator/National Study Coordinator Groups to remind their

sites (continuously from March 2015)

 Issue raised at Local Investigator meetings (2015)

 Local and Regional Trial Managers - continuously remind sites during monitoring
visits

Treatment guidelines for SUSTAIN 6

a

Please note that individual patient needs should be taken into consideration, both during
screening and when intensifying a treatment during the trial, similar to the approach
described in ADA and EASD treatment guidelines1,2

Blood glucose

Target

HbA1c ≤ 7.0% (individualized depending on patient). If HbA1c > 7.0%, additional HbA1c
measurement after 3 months. If HbA1c is still > 7.0%, treatment should be intensified to
achieve target if appropriate.

Therapy
Lifestyle modifications and metformin are considered foundational therapy in most
countries.

Add on to metformin: TZDs, SUs, alfa-glucosidase inhibitors, according to local practice

(DPP-4 inhibitors and other incretin based therapies are not allowed in SUSTAIN™ 6).
Insulin therapy should be based on local practice. Basal insulin and pre-mixed insulin can
be added. Bolus insulin could also be added after steady state of the maintenance dose of
semaglutide is reached.
Patients meeting the criteria for intensified treatment under the course of treatment with
maintenance dose of semaglutide, should be offered antihyperglycemic treatment
intensification at the discretion of Investigator.

60 
 
 Intensification
If appropriate glucose control cannot be ensured in the context of the clinical trial
protocol, trial medication should be discontinued permanently. Patients should be
encouraged to continue trial visits and assessments.

References:
1. Standards of Medical Care in Diabetes—2013, American Diabetes Association,
Diabetes Care, Volume 36, Suppl 1, January 2013.

2. Inzucchi SE et al, Management of hyperglycaemia in type 2 diabetes: a patient-

centered approach. Position statement of the American Diabetes Association (ADA)
and the European Association for the Study of Diabetes (EASD). Diabetologia.
2012 Jun;55(6):1577-96.

61 
 
Table S4. Clinical Event Definitions for All Adjudicated Outcomes

Event Definition
Acute Coronary Acute Coronary Syndrome (ACS) conditions include unstable angina
Syndrome pectoris (UAP) requiring hospitalization, non-ST elevation myocardial
infarction (MI) (NSTEMI) and ST elevation MI (STEMI).

Acute Myocardial General Considerations

Infarction The term myocardial infarction (MI) should be used when there is
evidence of myocardial necrosis in a clinical setting consistent with
myocardial ischemia.
In general, the diagnosis of MI requires the combination of:
 Evidence of myocardial necrosis (either changes in cardiac
biomarkers or post-mortem pathological findings); and
 Supporting information derived from the clinical
presentation, electrocardiographic changes, or the
results of myocardial or coronary artery imaging
The totality of the clinical, electrocardiographic, and cardiac biomarker
information should be considered to determine whether or not a MI
has occurred. Specifically, timing and trends in cardiac biomarkers
and electrocardiographic information require careful analysis. The
adjudication of MI should also take into account the clinical setting in
which the event occurs. MI may be adjudicated for an event that has
characteristics of a MI but which does not meet the strict definition
because biomarker or electrocardiographic results are not available.

Criteria for Myocardial Infarction

a. Clinical Presentation
The clinical presentation should be consistent with diagnosis of
myocardial ischemia and infarction. Other findings that might support
the diagnosis of MI should be taken into account because a number of
conditions are associated with elevations in cardiac biomarkers (e.g.,
trauma, surgery, pacing, ablation, congestive heart failure,
hypertrophic cardiomyopathy, pulmonary embolism, severe
pulmonary hypertension, stroke or subarachnoid hemorrhage,
infiltrative and inflammatory disorders of cardiac muscle, drug

62 
 
 toxicity, burns, critical illness, extreme exertion, and chronic kidney
disease). Supporting information can also be considered from
myocardial imaging and coronary imaging. The totality of the data
may help differentiate acute MI from the background disease process.
b. Biomarker Elevations
For cardiac biomarkers, laboratories should report an upper reference
limit (URL). If the 99th percentile of the upper reference limit (URL)
from the respective laboratory performing the assay is not available,
then the URL the laboratory uses to diagnose myocardial infarction
(decision limit) should be used. In general, troponins are preferred
and take precedence over CKMB when both biomarkers are available.
CK-MB should be used if troponins are not available, and total CK may
be used in the absence of CK-MB and troponin.
Since the prognostic significance of different types of myocardial
infarctions (e.g., periprocedural myocardial infarction versus
spontaneous myocardial infarction) may be different, all MI events will
be categorized by subtype as outlined in the third Universal Definition
for Myocardial Infarction.

ESC/ACCF/AHA/WHF Expert Consensus Document:

Third Universal Definition of Myocardial Infarction. K Thygesen, JS.
Alpert, AS. Jaffe, M L. Simoons, B R. Chaitman, H D. White
Circulation. 2012; August 24 2012.

c. Electrocardiogram (ECG) Changes

Electrocardiographic changes can be used to support or confirm a MI.
Supporting evidence may be ischemic changes and confirmatory
information may be new Q waves.
ECG manifestations of acute myocardial ischemia (in absence
of left ventricular hypertrophy [LVH] and left bundle branch
block [LBBB]):
o ST elevation

New ST elevation at the J point in two contiguous leads with the cut-
points: ≥ 0.1 mV in all leads other than leads V2-V3 where the

63 
 
 following cut-points apply: ≥ 0.2 mV in men ≥ 40 years (≥ 0.25 mV
in men < 40 years) or ≥ 0.15 mV in women.

o ST depression and T-wave changes

New horizontal or down-sloping ST depression ≥ 0.05 mV in two
contiguous leads and/or new T inversion ≥ 0.1 mV in two contiguous
leads with prominent R wave or R/S ratio > 1.

The above ECG criteria illustrate patterns consistent with myocardial

ischemia. In patients with abnormal biomarkers, it is recognized that
lesser ECG abnormalities may represent an ischemic response and
may be accepted under the category of abnormal ECG findings.

 Criteria for pathological Q-wave

o Any Q-wave in leads V2-V3 ≥ 0.02 seconds or QS
complex in leads V2 and V3
o Q-wave ≥ 0.03 seconds and ≥ 0.1 mV deep or QS
complex in leads I, II, aVL, aVF, or V4-V6 in any two
leads of a contiguous lead grouping (I, aVL; V1-V6; II,
III, and aVF)a. When considering the lateral leads, lead
V6, I, and aVL are considered contiguous leads.
a
The same criteria are used for supplemental leads V7–V9, and for the
Cabrera frontal plane lead grouping.

 ECG changes associated with prior myocardial infarction

o Pathological Q-waves, as defined above
o R-wave ≥ 0.04 seconds in V1-V2 and R/S ≥ 1 with a
concordant positive T-wave in the absence of a
conduction defect

 Criteria for prior myocardial infarction

Any one of the following criteria meets the diagnosis for prior MI:
o Pathological Q waves (as described above) with or
without symptoms in the absence of non-ischemic
causes

64 
 
 o Imaging evidence of a region of loss of viable
myocardium that is thinned and fails to contract, in
the absence of a non-ischemic cause
o Pathological findings of a prior myocardial infarction
Under these conditions, any one of the following criteria meets the
diagnosis for AMI:
 Type 1: Spontaneous MI related to ischemia due to a primary
coronary event such as plaque fissuring or rupturing.
 Type 2: MI secondary to ischemia due to imbalance between
oxygen demand and supplies, e.g. coronary spasm.
 Type 3: Sudden cardiac death with symptoms of myocardial
ischemia, accompanied by new ST elevation or LBBB, or
verified coronary thrombus by angiography, but death
occurring before blood samples could be obtained.
 Type 4a: MI associated with PCI
 Type 4b: stent thrombosis documented by angiography or
autopsy
 Type 4c: thrombosis not documented but restenosis is found
by angiography or autopsy with no other obvious cause that
explains the MI event.
 Type 5: MI associated with CABG.

Criteria for STEMI:

New ST elevation at the J point in two contiguous leads with the cut-
points: ≥ 0.1 mV in all leads other than leads V2-V3 where the
following cut-points apply: ≥ 0.2 mV in men ≥ 40 years (≥ 0.25 mV
in men < 40 years) or ≥ 0.15 mV in women.

Criteria for NSTEMI: Absence of ECG criteria for STEMI.

In patients with abnormal biomarkers, it is recognized that lesser ECG
abnormalities may represent an ischemic response and may be
accepted under the category of abnormal ECG findings.

65 
 
 Unstable Angina Unstable angina requiring hospitalization is defined as
Pectoris requiring 1. Ischemic discomfort (angina, or symptoms thought to be
hospitalization equivalent) ≥10 minutes in duration occurring
 at rest, or
 in an accelerating pattern with frequent episodes associated
with progressively decreased exercise capacity.
AND
2. Prompting an unscheduled hospitalization within 24 hours of
the most recent symptoms. Hospitalization is defined as an
admission to an inpatient unit or a visit to an emergency
department that results in at least a 24-hour stay (or a change
in calendar date if the hospital admission or discharge times
are not available).
AND
3. At least one of the following:
a. New or worsening ST or T wave changes on resting ECG (in the
absence of confounders, such as LBBB or LVH) Transient ST elevation
(duration <20 minutes)
New ST elevation at the J point in two contiguous leads with the
cut-points: ≥0.1 mV in all leads other than leads V2-V3 where the
following cut-points apply: ≥0.2 mV in men ≥40 years (≥0.25 mV in
men < 40 years) or ≥ 0.15 mV in women.
ST depression and T-wave changes
New horizontal or down-sloping ST depression ≥0.05 mV in two
contiguous leadsand/or new T inversion ≥0.3 mV in two contiguous
leads with prominent R wave or R/S ratio >1.

b. Definite evidence of inducible myocardial ischemia as demonstrated

by:
 an early positive exercise stress test, defined as ST elevation
or ≥2 mm ST depression prior to 5 mets
 OR
 stress echocardiography (reversible wall motion abnormality)
OR
 myocardial scintigraphy (reversible perfusion defect), OR

66 
 
  MRI (myocardial perfusion deficit under pharmacologic stress).

and believed to be responsible for the myocardial ischemic

symptoms/signs.

c. Angiographic evidence of new or worse ≥70% lesion and/or

thrombus in an epicardial coronary artery that is believed to be
responsible for the myocardial ischemic symptoms/signs.

d. Need for coronary revascularization procedure (PCI or CABG) for

the presumed culprit lesion(s). This criterion would be fulfilled if
revascularization was undertaken during the unscheduled
hospitalization, or subsequent to transfer to another institution
without interceding home discharge.
AND
4. Negative cardiac biomarkers and no evidence of acute MI
General Considerations
1. Escalation of pharmacotherapy for ischemia, such as intravenous
nitrates or increasing dosages of β-blockers, should be considered
supportive but not diagnostic of unstable angina. However, a typical
presentation and admission to the hospital with escalation of
pharmacotherapy, without any of the additional findings listed under
category 3, would be insufficient to support classification as
hospitalization for unstable angina.
2. If patients are admitted with suspected unstable angina, and
subsequent testing reveals a non-cardiac or non-ischemic etiology,
this event should not be recorded as hospitalization for unstable
angina. Potential ischemic events meeting the criteria for myocardial
infarction should not be adjudicated as unstable angina.
3. Planned hospitalization or rehospitalization for performance of an
elective revascularization in patients who do not fulfill the criteria for
unstable angina should not be considered a hospitalization for
unstable angina. For example,
 Hospitalization of a patient with stable exertional angina for
coronary angiography and PCI that is prompted by a positive

67 
 
 outpatient stress test should not be considered hospitalization
for unstable angina.
 Rehospitalization of a patient meeting the criteria for unstable
angina who was stabilized, discharged, and subsequently
readmitted for revascularization, does not constitute a second
hospitalization for unstable angina.
4. A patient who undergoes an elective catheterization where
incidental coronary artery disease is found and who subsequently
undergoes coronary revascularization will not be considered as
meeting the hospitalization for unstable angina endpoint.
Heart Failure A Heart Failure Event includes hospitalization for heart failure.
requiring A Heart Failure Hospitalization is defined as an event that meets
hospitalization ALL of the
following criteria:
1) The patient is admitted to the hospital with a primary
diagnosis of HF
2) The patient’s length-of-stay in hospital extends for at least
24 hours (or a change in calendar date if the hospital
admission and discharge times are unavailable)
3) The patient exhibits documented new or worsening symptoms
due to HF on presentation, including at least ONE of the
following:
a. Dyspnea (dyspnea with exertion, dyspnea at rest,
orthopnea, paroxysmal nocturnal dyspnea)
b. Decreased exercise tolerance
c. Fatigue
d. Other symptoms of worsened end-organ perfusion or
volume overload (must be specified and described by
the protocol)
4) The patient has objective evidence of new or worsening HF,
consisting of at least TWO physical examination findings OR
one physical examination finding and at least ONE laboratory
criterion), including:
a. Physical examination findings considered to be due to
heart failure, including new or worsened:

68 
 
 i. Peripheral edema
ii. Increasing abdominal distention or ascites (in
the absence of primary hepatic disease)
iii. Pulmonary rales/crackles/crepitations
iv. Increased jugular venous pressure and/or
hepatojugular reflux
v. S3 gallop
vi. Clinically significant or rapid weight gain thought
to be related to fluid retention
b. Laboratory evidence of new or worsening HF, if
obtained within 24 hours of presentation, including:
i. Increased B-type natriuretic peptide (BNP)/
N-terminal pro-BNP (NT-proBNP) concentrations
consistent with decompensation of heart failure
(such as BNP >500 pg/mL or NT-proBNP
>2,000 pg/mL). In patients with chronically
elevated natriuretic peptides, a significant
increase should be noted above baseline.
ii. Radiological evidence of pulmonary congestion
iii. Non-invasive diagnostic evidence of clinically
significant elevated left- or right-sided
ventricular filling pressure or low cardiac output.
For example, echocardiographic criteria could
include: E/e’ >15 or D-dominant pulmonary
venous inflow pattern, plethoric inferior vena
cava with minimal collapse on inspiration, or
decreased left ventricular outflow tract (LVOT)
minute stroke distance (time velocity integral
(TVI))
OR
iv. Invasive diagnostic evidence with right heart
catheterization showing a pulmonary capillary
wedge pressure (pulmonary artery occlusion
pressure) ≥18 mmHg, central venous pressure
≥12 mmHg, or a cardiac index <2.2 L/min/m2

69 
 
 Note: All results from diagnostic tests should be reported, if
available, even if they do not meet the above criteria, because
they provide important information for the adjudication of
these events.
5) The patient receives initiation or intensification of treatment
specifically for HF, including at least ONE of the following:
a. Augmentation in oral diuretic therapy
b. Intravenous diuretic, inotrope, or vasodilator therapy
c. Mechanical or surgical intervention, including:
i. Mechanical circulatory support (e.g., intra-aortic
balloon pump, ventricular assist device)
ii. Mechanical fluid removal (e.g., ultrafiltration,
hemofiltration, dialysis)
Cerebrovascular Introduction
Events (Stroke These definitions of Transient Ischemic Attack and Stroke apply to a
and TIA) wide range of clinical trials. They are general, overarching, and widely
applicable definitions combined with a specific clinical measurement of
disability. They are flexible in their application and consistent with
contemporary understanding of the pathophysiology of stroke. This
approach enables clinical trials to assess the clinically relevant
consequences of vascular brain injury for determining the safety
or effectiveness of an intervention.
The distinction between a Transient Ischemic Attack and an Ischemic
Stroke is the presence of infarction. Persistence of symptoms is an
acceptable indicator of acute infarction. In trials involving patients
with stroke, evidence of vascular central nervous system injury
without recognized neurological dysfunction may be observed.
Examples include microhemorrhage, silent infarction, and silent
hemorrhage. When encountered, the clinical relevance of these
findings may be unclear. If appropriate for a given clinical trial,
however, they should be precisely defined and categorized.
Subdural hematomas are intracranial hemorrhagic events and not
strokes.
Transient Ischemic Attack

70 
 
 Transient ischemic attack (TIA) is defined as a transient episode of
focal neurological dysfunction <24 hours in duration, caused by brain,
spinal cord, or retinal ischemia, without imaging evidence of acute
infarction.
Stroke
Stroke is defined as an acute episode of focal or global neurological
dysfunction caused by brain, spinal cord, or retinal vascular injury as
a result of hemorrhage or infarction.

Classification:
A. Ischemic Stroke
Ischemic stroke is defined as an acute episode of focal cerebral,
spinal, or retinal dysfunction caused by infarction of central nervous
system tissue.
Hemorrhage may be a consequence of ischemic stroke. In this
situation, the stroke is an ischemic stroke with hemorrhagic
transformation and not a hemorrhagic stroke.
B. Hemorrhagic Stroke
Hemorrhagic stroke is defined as an acute episode of focal or global
cerebral or spinal dysfunction caused by intraparenchymal,
intraventricular, or subarachnoid hemorrhage.
C. Undetermined Stroke
Undetermined stroke is defined as an acute episode of focal or global
neurological dysfunction caused by presumed brain, spinal cord, or
retinal vascular injury as a result of hemorrhage or infarction but with
insufficient information to allow categorization as A or B.
Fatal Events Definition of Cardiovascular Death
Cardiovascular death includes death resulting from an acute
myocardial infarction (MI), sudden cardiac death, death due to heart
failure (HF), death due to stroke, death due to cardiovascular (CV)
procedures, death due to CV hemorrhage, and death due to other
CV causes.

The following definitions will be used:

71 
 
 Death due to Acute Myocardial Infarction refers to a death by
any cardiovascular mechanism (e.g., arrhythmia, sudden death, heart
failure, stroke, pulmonary embolus, peripheral arterial disease)
≤30 days1 after a MI related to the immediate consequences of the
MI, such as progressive heart failure or recalcitrant arrhythmia. We
note that there may be assessable mechanisms of cardiovascular
death during this time period, but for simplicity, if the cardiovascular
death occurs ≤ 30 days of the myocardial infarction, it will be
considered a death due to myocardial infarction.
Acute MI should be verified to the extent possible by the diagnostic
criteria outlined for acute MI or by autopsy findings showing recent MI
or recent coronary thrombosis.
Death resulting from a procedure to treat a MI (percutaneous
coronary intervention (PCI), coronary artery bypass graft surgery
(CABG)), or to treat a complication resulting from MI, should also be
considered death due to acute MI.
Death resulting from an elective coronary procedure to treat
myocardial ischemia (i.e., chronic stable angina) or death due to a MI
that occurs as a direct consequence of a CV investigation/procedure/
operation should be considered as a death due to a CV procedure.

The 30 day cut-off is arbitrary. For example, if a patient that

has a complicated MI requiring intubation and is supported
though 30 days but dies shortly thereafter without an
intervening symptom free interval, the death should be
attributed to the myocardial infarction.
 Sudden Cardiac Death refers to a death that occurs
unexpectedly, not following an acute MI, and includes the
following deaths:
a. Death witnessed and occurring without new or
worsening symptoms
b. Death witnessed within 60 minutes of the onset of new
or worsening cardiac symptoms, unless the symptoms
suggest acute MI

72 
 
 c. Death witnessed and attributed to an identified
arrhythmia (e.g., captured on an electrocardiographic
(ECG) recording, witnessed on a monitor, or
unwitnessed but found on implantable cardioverter-
defibrillator review)
d. Death after unsuccessful resuscitation from cardiac
arrest
e. Death after successful resuscitation from cardiac arrest
and without identification of a specific cardiac or non-
cardiac etiology
f. Unwitnessed death in a patient seen alive and clinically
stable ≤24 hours prior to being found dead without any
evidence supporting a specific non-cardiovascular cause
of death (information regarding the patient’s clinical
status preceding death should be provided, if available)
General Considerations
Unless additional information suggests an alternate specific cause of
death (e.g., Death due to Other Cardiovascular Causes), if a patient is
seen alive ≤ 24 hours of being found dead, sudden cardiac death
(criterion 2f) should be recorded. For patients who were not observed
alive within 24 hours of death, undetermined cause of death should
be recorded (e.g., a patient found dead in bed, but who had not been
seen by family for several days).
 Death due to Heart Failure refers to a death in association
with clinically worsening symptoms and/or signs of heart
failure regardless of HF etiology. Deaths due to heart failure
can have various etiologies, including single or recurrent
myocardial infarctions, ischemic or non-ischemic
cardiomyopathy, hypertension, or valvular disease.
 Death due to Stroke refers to death after a stroke that is
either a direct consequence of the stroke or a complication of
the stroke. Acute stroke should be verified to the extent
possible by the diagnostic criteria outlined for stroke.
 Death due to Cardiovascular Procedures refers to death
caused by the immediate complications of a cardiac procedure.

73 
 
  Death due to Cardiovascular Hemorrhage refers to death
related to hemorrhage such as a non-stroke intracranial
hemorrhage, non-procedural or non-traumatic vascular rupture
(e.g., aortic aneurysm), or hemorrhage causing cardiac
tamponade.
 Death due to Other Cardiovascular Causes refers to a CV
death not included in the above categories but with a specific,
known cause (e.g., pulmonary embolism or peripheral arterial
disease).

Definition of Non-Cardiovascular Death

Non-cardiovascular death is defined as any death with a specific
cause that is not thought to be cardiovascular in nature. Detailed
recommendations on the classification of non-CV causes of death are
beyond the scope of this document.
Non-CV causes of death:
 Pulmonary
 Renal
 Gastrointestinal
 Hepatobiliary
 Pancreatic
 Infection (includes sepsis)
 Non-infectious (e.g., systemic inflammatory response
syndrome (SIRS))
 Hemorrhage that is neither cardiovascular bleeding or a stroke
(see
 Non-CV procedure or surgery
 Trauma
 Suicide
 Non-prescription drug reaction or overdose
 Prescription drug reaction or overdose
 Neurological (non-cardiovascular)
 Malignancy
 Other non-CV, specify: _________________

74 
 
 The definitions of classifications for CV and non-CV death are as
follows:
 Documented—There is documented evidence for classification
 Probable/Possible —There is good reason and sufficient
documentation. Conceivable and cannot be dismissed

Definition of Undetermined Cause of Death

Undetermined Cause of Death refers to a death not attributable to

one of the above categories of CV death or to a non-CV cause.
Inability to classify the cause of death may be due to lack of
information (e.g., the only available information is “patient died”) or
when there is insufficient supporting information or detail to assign
the cause of death. In general, most deaths should be classifiable as
CV or non-CV, and the use of this category of death, therefore, should
be used sparingly unless there is absolutely no information that allows
the adjudicator to determine causality.
All deaths attributed to the category “Undetermined Cause of death”
are presumed cardiovascular deaths and as such will be part of the
cardiovascular death endpoint.
Pancreatitis or Pancreatitis is an inflammatory process of the pancreas.
clinical suspicion Two of following diagnostic criteria fulfilling the diagnosis of acute
of pancreatitis pancreatitis:
 gradual or sudden severe pain in the central part of the
abdomen that moves around to the back
 elevated blood levels of pancreatic enzymes (lipase, amylase)
> 3xUNR
 characteristic imaging finding (ultrasound, CT, MRI)

Events of acute pancreatitis will be further classified according to

degree of severity based on revised Atlanta criteria.
 Mild acute pancreatitis (no organ failure and no local or
systemic complications)

75 
 
  Moderately severe acute pancreatitis (organ failure that
resolves within 48 h (transient organ failure) and/or local or
systemic complications without persistent organ failure)
 Severe acute pancreatitis (persistent organ failure (>48 h)
(single/multiple organs))
Reference: Banks PA, et al. Classification of acute pancreatitis -2012:
revision of the Atlanta classification and definitions by international
consensus. Gut 2013;62:102-111

Chronic pancreatitis will be defined by characteristic imaging finding

(ultrasound, CT, MRI) with abnormal pancreatic function tests or
characteristic histological findings.
Neoplasm Neoplasm is defined as an abnormal growth of tissue. All neoplasms
(malignant and will be captured.
benign)
(excluding Neoplasms will be classified according to the tissue of origin, the
thyroid organ system and to the malignancy status:
neoplasm) • Benign
• Malignant
• Pre-malignant/Carcinoma in situ/borderline
• Unclassified
Nephropathy New or worsening nephropathy defined as a new onset of persistent
macroalbuminuria, or persistent doubling of serum creatinine level
and creatinine clearance per MDRD <45 mL/min/1.73 m2, or the need
for continuous renal replacement therapy (in the absence of an acute
reversible cause) or death due to renal disease.

Macroalbuminuria is defined either as a 24-hour urine collection above

300 mg, or as an elevated ratio in a spot sample above 300 mg
albumin/g creatinine.

To confirm persistent macroalbuminuria or persistent doubling of

serum creatinine, a confirmatory measurement should be performed
within 12 weeks.

76 
 
 Diabetic Diabetic retinopathy defined as need for retinal photocoagulation or
retinopathy treatment with intravitreal agents or vitreous hemorrhage or
diabetes-related-blindness (defined as Snellen visual acuity of 20/200
[6/60] or less or visual field of less than 20 degrees, in the better eye
with best correction possible).

Thyroid Disease All thyroid diseases requiring thyroidectomy, including partial

(if thyroid thyroidectomy (e.g. lobectomy, partial lobectomy) will be adjudicated.
neoplasm or
All thyroid neoplasms will be adjudicated.
resulting in
thyroidectomy) 
Medullary carcinoma of the thyroid (MTC) is defined as a distinct
thyroid carcinoma that originates in the calcitonin producing
parafollicular C cells of the thyroid gland. According to the pathology
report, thyroid neoplasms deriving from the C cells will be classified
as C-cell hyperplasia, medullary microcarcinoma (carcinoma in situ)
and medullary carcinoma.
Coronary A coronary revascularization procedure is a percutaneous coronary
Revascularization intervention (PCI) or an open surgical procedure designed to improve
Procedure myocardial blood flow. Percutaneous Coronary Intervention (PCI):
Placement of an angioplasty guide wire, balloon, or other device (e.g.,
stent, atherectomy catheter, brachytherapy delivery device, or
thrombectomy catheter) into a native coronary artery or coronary
artery bypass graft for the purpose of mechanical coronary
revascularization. In the assessment of the severity of coronary
lesions with the use of intravascular ultrasound, CFR, or FFR, insertion
of a guide wire will NOT be considered PCI.

77 
 
 

Table S5. Premature Treatment Discontinuation

Semaglutide Semaglutide Placebo Placebo Total

0.5 mg 1.0 mg 0.5 mg 1.0 mg

N (%) N (%) N (%) N (%) N (%)

Premature treatment discontinuation 164 (19.9) 186 (22.6) 151 (18.3) 159 (19.3) 660 (20.0)

Gastrointestinal tolerability 47 (5.7) 77 (9.4) 10 (1.2) 8 (1.0) 142 (4.3)

Withdrawal of informed consent 1 (0.1) 1 (0.1) 1 (0.1) 1 (0.1) 4 (0.1)

Adverse event other than related to 51 (6.2) 41 (5.0) 38 (4.6) 55 (6.7) 185 (5.6)

gastrointestinal tolerability

Introduction of disallowed medication 3 (0.4) 3 (0.4) 8 (1.0) 8 (1.0) 22 (0.7)

Suspicion of placebo 3 (0.4) 3 (0.4) 15 (1.8) 10 (1.2) 31 (0.9)

Randomized in error 12 (1.5) 13 (1.6) 16 (1.9) 6 (0.7) 47 (1.4)

Resistance to injections 2 (0.2) 0 2 (0.2) 0 4 (0.1)

78 
 
 

Trial fatigue 5 (0.6) 5 (0.6) 15 (1.8) 11 (1.3) 36 (1.1)

Other 40 (4.8) 43 (5.2) 46 (5.6) 60 (7.3) 189 (5.7)

Data shown are primary reasons for treatment discontinuation as reported by the investigator.

   

79 
 
 

Table S6. Baseline Characteristics (Expanded)

Semaglutide Semaglutide Placebo Placebo Total

0.5 mg 1.0 mg 0.5 mg 1.0 mg

(n=826) (n=822) (n=824) (n=825) (N=3297)

Age (year)a 64.6 (7.3) 64.7 (7.1) 64.8 (7.6) 64.4 (7.5) 64.6 (7.4)

Sex (N, %)

Male 495 (59.9) 518 (63.0) 482 (58.5) 507 (61.5) 2002 (60.7)

Ethnicity (N, %)

Hispanic or Latino 132 (16.0) 124 (15.1) 117 (14.2) 137 (16.6) 510 (15.5)

Not Hispanic or
694 (84.0) 698 (84.9) 707 (85.8) 688 (83.4) 2787 (84.5)
Latino

Race (N, %)

White 693 (83.9) 691 (84.1) 676 (82.0) 676 (81.9) 2736 (83.0)

Black or African
54 (6.5) 54 (6.6) 54 (6.6) 59 (7.2) 221 (6.7)
American

80 
 
 

Asian 63 (7.6) 58 (7.1) 80 (9.7) 72 (8.7) 273 (8.3)

Other 16 (1.9) 19 (2.3) 14 (1.7) 18 (2.2) 67 (2.0)

Body weight 91.8 92.9 91.8 91.9 92.1

(kg)a (20.25) (21.05) (20.35) (20.75) (20.60)

32.7 32.9 32.9 32.7 32.8

BMI (kg/m2)a
(6.29) (6.18) (6.35) (5.97) (6.20)

Type 2 diabetes,

mean (SD)

Diabetes 14.3 14.1 14.0 13.2 13.9

duration (years) (8.21) (8.17) (8.54) (7.44) (8.11)

Glycated 8.7 8.7 8.7 8.7 8.7

hemoglobin (%) (1.39) (1.51) (1.49) (1.45) (1.46)

Cardiovascular

risk factors

81 
 
 

Systolic/diastolic
136.1 77.1 135.8 76.9 135.8 77.5 134.8 76.7 135.6 77.0
blood pressure
(17.97) (9.78) (16.96) (10.21) (16.16) (9.85) (17.45) (10.21) (17.15) (10.02)
(mmHg)a

Pulse (beats per 72.7 71.5 72.0 72.0 72.0

minute)a (11.22) (10.86) (10.62) (10.92) (10.91)

LDL cholesterol 81.6 83.3 80.9 83.6 82.3

(mg/dl)b (47.05) (41.17) (48.10) (45.89) (45.61)

HDL cholesterol 44.2 43.4 44.2 43.1 43.7

(mg/dl)b (27.76) (26.9) (27.3) (26.3) (27.1)

Never smokedc 390 (47.2) 364 (44.3) 391 (47.5) 348 (42.2) 1493 (45.3)

History of

cardiovascular

disease (N, %)

Ischemic heart
493( 59.7) 495( 60.2) 510( 61.9) 496( 60.1) 1994( 60.5)
disease

82 
 
 

Myocardial
266 (32.2) 264 (32.1) 267 (32.4) 275 (33.3) 1072 (32.5)
infarction

Heart failure 201 (24.3) 180 (21.9) 190 (23.1) 206 (25.0) 777 (23.6)

Ischemic stroke 89 (10.8) 89 (10.8) 96 (11.7) 109 (13.2) 383 (11.6)

Hemorrhagic
28 (3.4) 24 (2.9) 27 (3.3) 29 (3.5) 108 (3.3)
stroke

Hypertension 772 (93.5) 771 (93.8) 756 (91.7) 760 (92.1) 3059 (92.8)

Renal function

(N, %)

Normal (eGFR
247 (29.9) 246 (29.9) 245 (29.7) 252 (30.5) 990 (30.0)
≥90)

Mild renal

impairment 329 (39.8) 357 (43.4) 336 (40.8) 346 (41.9) 1368 (41.5)

(eGFR 60 ‒ <90)

83 
 
 

Moderate renal

impairment 229 (27.7) 194 (23.6) 215 (26.1) 194 (23.5) 832 (25.2)

(eGFR 30 ‒ <60)

Severe renal

impairment 20 (2.4) 21 (2.6) 25 (3.0) 29 (3.5) 95 (2.9)

(eGFR 15 ‒ <30)

End-stage renal

disease (eGFR 1 (0.1) 4 (0.5) 3 (0.4) 4 (0.5) 12 (0.4)

<15)

Renal function is based on estimated glomerular filtration rate (MDRD) (ml/min/1.73 m2). aMeans and standard deviations;

b
Geometric means and coefficients of variation; cNumber of patients (N) and percentage (%).

Note: mmol/l = mg per deciliter/18.

BMI, body mass index; LDL, low-density lipoprotein; MDRD, modification of diet in renal disease; SD, standard deviation.

   

84 
 
 

Table S7A. Antihyperglycemic Medication at Baseline

Semaglutide Semaglutide Placebo Placebo Total

0.5 mg 1.0 mg 0.5 mg 1.0 mg

N (%) N (%) N (%) N (%) N (%)

Glucose-lowering 817 (98.9) 808 (98.3) 806 (97.8) 814 (98.7) 3245 (98.4)

medication

No glucose-lowering 9 (1.1) 14 (1.7) 18 (2.2) 11 (1.3) 52 (1.6)

medication

Insulin 479 (58.0) 477 (58.0) 478 (58.0) 479 (58.1) 1913 (58.0)

Basal insulin 256 (31.0) 259 (31.5) 259 (31.4) 272 (33.0) 1046 (31.7)

Basal+bolus insulin/pre-mix 223 (27.0) 218 (26.5) 219 (26.6) 207 (25.1) 867 (26.3)

Bolus insulin NA NA NA NA NA

Non-insulin glucose- 695 (84.1) 684 (83.2) 696 (84.5) 701 (85.0) 2776 (84.2)

lowering medication

Alpha-glucosidase inhibitors 9 (1.1) 7 (0.9) 16 (1.9) 10 (1.2) 42 (1.3)

85 
 
 

Biguanides 617 (74.7) 594 (72.3) 586 (71.1) 617 (74.8) 2414 (73.2)

Glucose-lowering 1 (0.1) 1 (0.1) – 1 (0.1) 3 (0.1)

combination therapya

DPP-4 inhibitorsb 1 (0.1) 2 (0.2) 2 (0.2) – 5 (0.2)

Meglitinides 25 (3.0) 23 (2.8) 24 (2.9) 15 (1.8) 87 (2.6)

SGLT-2 – 1 (0.1) 2 (0.2) 2 (0.2) 5 (0.2)

Sulfonylurea 349 (42.3) 349 (42.5) 363 (44.1) 349 (42.3) 1410 (42.8)

Thiazolidinedione 14 (1.7) 21 (2.6) 18 (2.2) 23 (2.8) 76 (2.3)

a
Fixed-dose combination; bDPP-4 (dipeptidyl peptidase-4) use was listed as an exclusion criterion, patients were randomized in

error; NA, not allowed at baseline. Data are reported use of antihyperglycemic medication ongoing at baseline.

86 
 
 

Table S7B. Introduction of Antihyperglycemic Medication During the Trial

Semaglutide Semaglutide Placebo Placebo Total

Addition of 0.5 mg 1.0 mg 0.5 mg 1.0 mg

N (%) N (%) N (%) N (%) N (%)

Glucose-lowering
172 (20.8)*** 160 (19.5)*** 345 (41.9) 325 (39.4) 1002 (30.4)
medication

Insulin 85 (10.3)*** 70 (8.5)*** 204 (24.8) 191 (23.2) 550 (16.7)

Basal insulin 31 (3.8)*** 20 (2.4)*** 98 (11.9) 93 (11.3) 242 (7.3)

Basal+bolus insulin/ 60 (7.3)*** 50 (6.1)*** 123 (14.9) 118 (14.3) 351 (10.6)

pre-mix

Bolus insulin 2 (0.2) 5 (0.6) 7 (0.8) 1 (0.1) 15 (0.5)

Non-insulin glucose- 104 (12.6)*** 111 (13.5)*** 199 (24.2) 197 (23.9) 611 (18.5)

lowering medication

Alpha glucosidase 1 (0.1)* 4 (0.5) 8 (1.0) 11 (1.3) 24 (0.7)

medication

87 
 
 

Biguanides 30 (3.6) 21 (2.6) 46 (5.6) 29 (3.5) 126 (3.8)

Glucose-lowering 4 (0.5) – 4 (0.5) 2 (0.2) 10 (0.3)

combination therapya

DPP4-inhibitors 14 (1.7)* 22 (2.7) 32 (3.9) 21 (2.5) 89 (2.7)

GLP-1 receptor agonists 8 (1.0)* 15 (1.8) 7 (0.8) 9 (1.1) 39 (1.2)

Meglitinides 7 (0.8) 4 (0.5)* 14 (1.7) 13 (1.6) 38 (1.2)

SGLT-2 21 (2.5)* 23 (2.8)** 40 (4.9) 53 (6.4) 137 (4.2)

Sulfonylureas 29 (3.5)** 32 (3.9)** 60 (7.3) 67 (8.1) 188 (5.7)

Thiazolidinediones 7 (0.8)** 7 (0.9)** 30 (3.6) 28 (3.4) 72 (2.2)

*P<0.05; **P<0.001; ***P<0.0001 for volume-matched comparison using logistic regression with treatment (four levels:

semaglutide 0.5 mg, semaglutide 1.0 mg, placebo 0.5 mg and placebo 1.0 mg) and stratification (9 levels) as fixed factors and

baseline HbA1c as covariate. Introduction of antihyperglycemic medication is defined as use of a new medication as compared to

baseline for at least 21 consecutive days. aFixed-dose combination.

88 
 
 

Table S8A. Cardiovascular Medication at Baseline

Semaglutide Semaglutide Placebo Placebo

Total
0.5 mg 1.0 mg 0.5 mg 1.0 mg

N (%) N (%) N (%) N (%) N (%)

Cardiovascular
806 (97.6) 809 (98.4) 809 (98.2) 810 (98.2) 3234 (98.1)
medication

Antihypertensives 773 (93.6) 780 (94.9) 757 (91.9) 772 (93.6) 3082 (93.5)

Beta blockers 475 (57.5) 459 (55.8) 475 (57.6) 485 (58.8) 1894 (57.4)

Calcium-channel blockers 273 (33.1) 246 (29.9) 266 (32.3) 270 (32.7) 1055 (32.0)

ACE inhibitors 420 (50.8) 409 (49.8) 402 (48.8) 411 (49.8) 1642 (49.8)

Angiotensin-receptor
274 (33.2) 274 (33.3) 266 (32.3) 297 (36.0) 1111 (33.7)
blockers

89 
 
 

Other antihypertensives 63 (7.6) 60 (7.3) 67 (8.1) 68 (8.2) 258 (7.8)

Diuretics 318 (38.5) 306 (37.2) 306 (37.1) 330 (40.0) 1260 (38.2)

Loop diuretics 146 (17.7) 134 (16.3) 133 (16.1) 143 (17.3) 556 (16.9)

Thiazides 114 (13.8) 119 (14.5) 107 (13.0) 129 (15.6) 469 (14.2)

Thiazide-like diuretics 60 (7.3) 58 (7.1) 61 (7.4) 55 (6.7) 234 (7.1)

Aldosterone antagonists 52 (6.3) 45 (5.5) 55 (6.7) 42 (5.1) 194 (5.9)

Lipid-lowering 634 (76.8) 629 (76.5) 618 (75.0) 640 (77.6) 2521 (76.5)

Statins 600 (72.6) 599 (72.9) 590 (71.6) 610 (73.9) 2399 (72.8)

Ezetimibe 32 (3.9) 31 (3.8) 34 (4.1) 32 (3.9) 129 (3.9)

Other lipid-lowering drugs 94 (11.4) 95 (11.6) 68 (8.3) 100 (12.1) 357 (10.8)

90 
 
 

Anti-thrombotic 625 (75.7) 627 (76.3) 625 (75.8) 637 (77.2) 2514 (76.3)

Vitamin K agonists 48 (5.8) 40 (4.9) 40 (4.9) 36 (4.4) 164 (5.0)

Direct thrombin inhibitors 5 (0.6) 4 (0.5) 4 (0.5) 5 (0.6) 18 (0.5)

Direct factor Xa inhibitors 2 (0.2) 1 (0.1) 9 (1.1) 1 (0.1) 13 (0.4)

ADP receptor inhibitors

(excluding acetylsalicylic 175 (21.2) 164 (20.0) 168 (20.4) 189 (22.9) 696 (21.1)

acid)

Acetylsalicylic acid 509 (61.6) 542 (65.9) 522 (63.3) 535 (64.8) 2108 (63.9)

ACE, angiotensin-converting-enzyme; ADP, adenosine diphosphate. Data are reported use of cardiovascular medication ongoing

at baseline.

91 
 
 

Table S8B. Introduction of Cardiovascular Medication During the Trial

Semaglutide Semaglutide Placebo Placebo Total

Addition of 0.5 mg 1.0 mg 0.5 mg 1.0 mg

N (%) N (%) N (%) N (%) N (%)

Cardiovascular
305 (36.9)** 291 (35.4)* 372 (45.1) 346 (41.9) 1314 (39.9)
medication

Antihypertensives 168 (20.3)* 151 (18.4)* 202 (24.5) 198 (24.0) 719 (21.8)

Beta blockers 45 (5.4) 48 (5.8) 57 (6.9) 50 (6.1) 200 (6.1)

Calcium channel
45 (5.4)* 46 (5.6)* 74 (9.0) 79 (9.6) 244 (7.4)
blockers

ACE inhibitors 42 (5.1) 40 (4.9) 42 (5.1) 37 (4.5) 161 (4.9)

92 
 
 

Angiotensin II receptor
46 (5.6) 42 (5.1) 56 (6.8) 54 (6.5) 198 (6.0)
blockers

Other antihypertensives 38 (4.6) 20 (2.4) 28 (3.4) 33 (4.0) 119 (3.6)

Diuretics 103 (12.5)* 87 (10.6)* 150 (18.2) 130 (15.8) 470 (14.3)

Loop diuretics 53 (6.4)* 37 (4.5)** 83 (10.1) 76 (9.2) 249 (7.6)

Thiazides 28 (3.4) 26 (3.2) 40 (4.9) 26 (3.2) 120 (3.6)

Thiazide-like diuretics 15 (1.8) 10 (1.2)* 18 (2.2) 28 (3.4) 71 (2.2)

Aldosterone antagonists 23 (2.8) 22 (2.7) 34 (4.1) 36 (4.4) 115 (3.5)

Lipid-lowering 87 (10.5) 67 (8.2)* 98 (11.9) 107 (13.0) 359 (10.9)

medication

Statins 58 (7.0) 51 (6.2)* 70 (8.5) 75 (9.1) 254 (7.7)

93 
 
 

Ezetimibe 7 (0.8) 4 (0.5) 8 (1.0) 12 (1.5) 31 (0.9)

Other lipid-lowering
31 (3.8) 16 (1.9) 31 (3.8) 26 (3.2) 104 (3.2)
drugs

Anti-thrombotic
108 (13.1)* 118 (14.4) 137 (16.6) 118 (14.3) 481 (14.6)
medication

Vitamin K agonists 15 (1.8) 24 (2.9) 16 (1.9) 13 (1.6) 68 (2.1)

Direct thrombin
5 (0.6) 5 (0.6) 5 (0.6) 6 (0.7) 21 (0.6)
inhibitors

Direct factor Xa inhibitors 20 (2.4) 15 (1.8) 25 (3.0) 18 (2.2) 78 (2.4)

ADP receptor inhibitors

(excluding acetylsalicylic 45 (5.4) 54 (6.6) 58 (7.0) 58 (7.0) 215 (6.5)

acid)

Acetylsalicylic acid 42 (5.1) 37 (4.5) 52 (6.3) 44 (5.3) 175 (5.3)

94 
 
 

*P<0.05; **P<0.001; ***P<0.0001 for volume-matched comparison using logistic regression with treatment (four levels:

semaglutide 0.5 mg, semaglutide 1.0 mg, placebo 0.5 mg and placebo 1.0 mg) and stratification (9 levels) as fixed factors.

Introduction of cardiovascular medication is defined as use of a new medication as compared to baseline.

ACE, angiotensin-converting-enzyme; ADP, adenosine diphosphate

95 
 
 

Table S9. Primary and Secondary Cardiovascular and Microvascular Outcomes (Expanded)

Semaglutide Placebo Hazard Ratio P value

(n=1648) (n=1649) (95% CI)

Incidence Incidence

rate rate
No. (%) No. (%)
per 100 per 100

PYR PYR

Primary composite <0.001

outcome† (non-

108 (6.6) 3.24 146 (8.9) 4.44 0.74 0.58 ; 0.95 inferiority)

0.02

(superiority)

Expanded composite
199 (12.1) 6.17 264 (16.0) 8.36 0.74 0.62 ; 0.89 0.002
outcome‡

All-cause death, non-

122 (7.4) 3.66 158 (9.6) 4.81 0.77 0.61 ; 0.97 0.03
fatal myocardial

96 
 
 

infarction, or non-

fatal stroke‡

All-cause death 62 (3.8) 1.82 60 (3.6) 1.76 1.05 0.74 ; 1.50 0.79

Cardiovascular death 44 (2.7) 1.29 46 (2.8) 1.35 0.98 0.65 ; 1.48 0.92

Non-fatal myocardial

infarction (including 47 (2.9) 1.40 64 (3.9) 1.92 0.74 0.51 ; 1.08 0.12

silent)

Acute myocardial
51 (3.1) 1.52 60 (3.6) 1.80 0.85 0.58; 1.23 0.38
infarction

Silent myocardial
4 (0.2) 0.12 7 (0.4) 0.21 0.57 0.17; 1.94 0.37
infarction

Non-fatal stroke 27 (1.6) 0.80 44 (2.7) 1.31 0.61 0.38 ; 0.99 0.044

Hemorrhagic stroke 2 (0.1) 0.06 4 (0.2) 0.12 0.50 0.09; 2.72 0.42

Ischemic stroke 25 (1.5) 0.74 37 (2.2) 1.10 0.67 0.40; 1.11 0.12

Unclassified stroke 0 0.00 3 (0.2) 0.09

97 
 
 

Hospitalization for

unstable angina 22 (1.3) 0.65 27 (1.6) 0.80 0.82 0.47 ; 1.44 0.49

pectoris

Revascularization 83 (5.0) 2.50 126 (7.6) 3.85 0.65 0.50 ; 0.86 0.003

Peripheral 16 (1.0) 0.47 25 (1.5) 0.74 0.64 0.34 ; 1.20 0.16

Coronary 70 (4.2) 2.10 103 (6.2) 3.13 0.67 0.50 ; 0.91 0.010

Hospitalization for
59 (3.6) 1.76 54 (3.3) 1.61 1.11 0.77 ; 1.61 0.57
heart failure

Retinopathy
50 (3.0) 1.49 29 (1.8) 0.86 1.76 1.11 ; 2.78 0.02
complications

Need for retinal

38 (2.3) 1.13 20 (1.2) 0.59 1.91 1.11 ; 3.28 0.02
photocoagulation

Vitreous
16 (1.0) 0.47 7 (0.4) 0.21 2.29 0.94 ; 5.57 0.07
hemorrhage

98 
 
 

Need for

treatment with 16 (1.0) 0.47 13 (0.8) 0.38 1.23 0.59 ; 2.56 0.58

intravitreal agent

Onset of diabetes-
5 (0.3) 0.15 1 (0.1) 0.03 5.01 0.59 ; 42.88 0.14
related blindness

New or worsening
62 (3.8) 1.86 100 (6.1) 3.06 0.64 0.46 ; 0.88 0.005
nephropathy

Persistent
44 (2.7) 1.31 81 (4.9) 2.47 0.54 0.37 ; 0.77 0.001
macroalbuminuria

Persistent

doubling of serum

creatinine level

and creatinine 18 (1.1) 0.53 14 (0.8) 0.41 1.28 0.64 ; 2.58 0.48

clearance per

MDRD <45

ml/min/1.73m2

99 
 
 

Need for

continuous renal-
11 (0.7) 0.32 12 (0.7) 0.35 0.91 0.40 ; 2.07 0.83
replacement

therapy

†
The primary composite outcome in the time-to-event analysis consisted of the first occurrence of either death from

cardiovascular causes, non-fatal myocardial infarction or non-fatal stroke. ‡The expanded composite outcome included death

from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, revascularization (coronary and peripheral),

hospitalization for unstable angina or heart failure. MDRD, modification of diet in renal disease; PYR, patient years of risk time

(time from randomization until first event or censoring). Hazard ratios and P values are estimated using a Cox proportional-

hazards model with treatment (semaglutide, placebo) as a fixed factor. For the pre-specified time to event endpoints, the

model was stratified by all combinations of stratification factors used in the randomization. For the sub-components of non-fatal

myocardial infarction, non-fatal stroke, revascularization, retinopathy and nephropathy specified post-hoc, an un-stratified Cox

proportional hazards model was applied. All P values are two-sided with 5% significance level. Other P values than for the

primary hypothesis are unadjusted for multiplicity and test null-hypotheses of no difference.

All analyses are based on the in-trial observation period. Thus, patients not experiencing an event are censored at their end-of-

trial visit (scheduled at Week 109), death or last direct patient-site contact, whichever came first.

100 
 
 

Table S10. Change from Baseline at Week 104 for Glycated Hemoglobin, Body Weight, Blood Pressure and Pulse, and Ratio to

Baseline at Week 104 for Lipids

Total mean at Semaglutide Semaglutide Placebo Placebo

baseline 0.5 mg 1.0 mg 0.5 mg 1.0 mg

Number of patients 826 822 824 825

Glycated hemoglobin, % 8.7 –1.1 –1.4 –0.4 –0.4

- –0.66*** –1.05***
ETD vs placebo (95% CI)
(–0.80 ; –0.52) (–1.19 ; –0.91)

Glycated hemoglobin,
71.6 –11.9 –15.4 –4.8 –3.9
mmol/mol

- –7.17*** –11.48***
ETD vs placebo (95% CI)
(–8.67 ; –5.66) (–12.99 ; –9.97)

Body weight, kg 92.1 –3.6 –4.9 –0.7 –0.5

- –2.87*** –4.35***
ETD vs placebo (95% CI)
(–3.47 ; –2.28) (–4.94 ; –3.75)

101 
 
 

Blood pressure

Systolic blood pressure,

135.6 –3.44 –5.37 –2.17 –2.78
mmHg

–1.27 –2.59**
ETD vs placebo (95% CI)
(–2.77 ; 0.23) (–4.09 ; –1.08)

Diastolic blood pressure,

77.0 –1.37 –1.57 –1.42 –1.71
mmHg

0.04 0.14
ETD vs placebo (95% CI)
(–0.83 ; 0.92) (–0.74 ; 1.03)

Pulse rate, bpm 72.0 2.12 2.41 0.09 –0.07

2.02*** 2.47***
ETD vs placebo (95% CI)
(1.07 ; 2.98) (1.52 ; 3.43)

Lipids

Total cholesterol, 165.17

0.97 0.97 1.00 0.99  
ratio to baseline mg/dl

102 
 
 

0.97* 0.99
ETR vs placebo (95% CI)  
(0.95 ; 1.00) (0.97 ; 1.01)

LDL cholesterol, 82.32

0.97 0.98 1.01 0.99  
ratio to baseline mg/dl

0.96* 0.99
ETR vs placebo (95% CI)  
(0.93 ; 0.99) (0.96 ; 1.03)

HDL cholesterol, ratio to 43.73

0.99 1.01 0.99 0.97  
baseline mg/dl

1.00 1.04***
ETR vs placebo (95% CI)  
(0.99 ; 1.02) (1.02 ; 1.06)

Triglycerides, 161.96
0.93 0.92 0.96 0.98  
ratio to baseline mg/dl

0.97 0.93**
ETR vs placebo (95% CI)  
(0.93 ; 1.01) (0.89 ; 0.97)

Free fatty acids, 0.82

0.95 0.91 0.96 0.99  
ratio to baseline mmol/l

103 
 
 

0.99 0.92**
ETR vs placebo (95% CI)  
(0.95 ; 1.04) (0.88 ; 0.96)

Data are estimated mean changes/ratios from/to baseline, and treatment differences/ratios with confidence intervals, based on

in-trial data for scheduled visits for the full analysis set.

Each parameter was analyzed by a mixed model for repeated measures with treatment group (four levels: 0.5 mg semaglutide,

1.0 mg semaglutide, 0.5 mg semaglutide placebo, 1.0 mg semaglutide placebo) and stratification (9 levels) as fixed factors and

the corresponding baseline value of the parameter as a covariate, all nested within visit.

Lipid parameters were analyzed on log-scale with means at baseline presented as geometric means.

bpm, beats/minute; CI, confidence interval; ETD, estimated treatment difference; ETR, estimated treatment ratio; HDL, high-

density lipoprotein cholesterol; LDL, low-density lipoprotein cholesterol; MMRM, mixed models for repeated measurements.

*P<0.05; **P<0.001; ***P<0.0001.

104 
 
 

Table S11. Serious Adverse Events by System Organ Class

Semaglutide Semaglutide Placebo Placebo

0.5 mg 1.0 mg 0.5 mg 1.0 mg

N (%) R N (%) R N (%) R N (%) R

Serious adverse

events by system 289 (35.0) 43.5 276 (33.6) 36.7 329 (39.9) 44.8 298 (36.1) 41.1

organ class

Cardiac disorders 110 (13.3) 10.5 91 (11.1) 9.0 122 (14.8) 10.0 108 (13.1) 10.0

Infections and
69 (8.4) 5.5 55 (6.7) 3.9 81 (9.8) 6.3 67 (8.1) 4.9
infestations

Surgical and medical

47 (5.7) 3.3 40 (4.9) 2.6 65 (7.9) 4.1 62 (7.5) 4.4
procedures

Nervous system
41 (5.0) 3.0 33 (4.0) 2.7 56 (6.8) 4.0 39 (4.7) 3.0
disorders

Renal and urinary

45 (5.4) 3.2 27 (3.3) 1.9 39 (4.7) 2.6 35 (4.2) 2.5
disorders

105 
 
 

Neoplasms benign,

malignant and
22 (2.7) 1.6 39 (4.7) 2.8 35 (4.2) 2.2 29 (3.5) 1.8
unspecified (including

cysts and polyps)

Gastrointestinal
40 (4.8) 2.6 35 (4.3) 2.6 22 (2.7) 1.5 28 (3.4) 2.2
disorders

Respiratory, thoracic

and mediastinal 26 (3.1) 2.0 24 (2.9) 2.0 25 (3.0) 1.8 26 (3.2) 2.0

disorders

Injury, poisoning and

procedural 27 (3.3) 1.8 23 (2.8) 1.5 28 (3.4) 2.1 26 (3.2) 1.8

complications

Metabolism and
26 (3.1) 1.8 16 (1.9) 1.0 27 (3.3) 2.2 22 (2.7) 1.4
nutrition disorders

Musculoskeletal and

connective tissue 15 (1.8) 1.0 21 (2.6) 1.3 23 (2.8) 1.8 23 (2.8) 1.5

disorders

106 
 
 

General disorders and

administration-site 19 (2.3) 1.1 15 (1.8) 1.1 23 (2.8) 1.5 17 (2.1) 1.1

conditions

Vascular disorders 22 (2.7) 1.5 11 (1.3) 0.9 17 (2.1) 1.0 17 (2.1) 1.1

Eye disorders 12 (1.5) 0.9 11 (1.3) 0.7 7 (0.8) 0.4 13 (1.6) 0.9

Hepatobiliary
13 (1.6) 0.8 6 (0.7) 0.4 16 (1.9) 1.2 9 (1.1) 0.6
disorders

Skin and

subcutaneous 13 (1.6) 1.0 4 (0.5) 0.3 7 (0.8) 0.4 6 (0.7) 0.6

tissue disorders

Investigations 5 (0.6) 0.6 5 (0.6) 0.4 6 (0.7) 0.5 7 (0.8) 0.4

Blood and lymphatic

9 (1.1) 0.5 8 (1.0) 0.5 3 (0.4) 0.2 6 (0.7) 0.4
system disorders

Psychiatric disorders 3 (0.4) 0.2 7 (0.9) 0.4 7 (0.8) 0.5 4 (0.5) 0.2

Reproductive system
5 (0.6) 0.3 7 (0.9) 0.4 4 (0.5) 0.3 3 (0.4) 0.2
and breast disorders

Endocrine disorders 1 (0.1) 0.1 2 (0.2) 0.1 2 (0.2) 0.1 2 (0.2) 0.1

107 
 
 

Ear and labyrinth

1 (0.1) 0.1 0 – – 3 (0.4) 0.2 0 – –
disorders

Immune system
3 (0.4) 0.2 1 (0.1) 0.1 1 (0.1) 0.1 1 (0.1) 0.1
disorders

Congenital, familial
0 – – 1 (0.1) 0.1 0 – – 0 – –
and genetic disorders

R: event rate per 100 observation years.

108