Ryzodeg Presentation in Ramadan by DR Shahjada Selim

2/22/2021 Ryzodeg presentation in ramadan by dr shahjada selim
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Bangabandhu Sheikh Mujib Medical University

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Published on Jun 14, 2015
Insulin degludec/insulin aspart- an overview of co-formulation insulin
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Ryzodeg presentation in ramadan by dr shahjada selim
1. 1. Insulin degludec/insulin aspart- an overview of co-formulation insulin analogue and use in Ramadan
Dr Shahjada Selim Assistant Professor Department of Endocrinology Bangabandhu Sheikh Mujib
Medical University, Dhaka Presentation title Date 1
2. 2. Diabetes is a huge and growing problem, and the costs to society are high and escalating 382 million
people have diabetes By 2035, this number will rise to 592 million
3. 3. Diabetes: Facts and figures Almost half of all people with diabetes live in just three countries China
Indian Subcontinent USA About 6 Million people of Bangladesh are affected by Diabetes (5.9 million
as per IDF 2014) Source: IDF Diabetes Atlas Sixth Edition, International Diabetes Federation 2013
4. 4. 4 Better HbA1c control is associated with reductions in long-term health complications Every 1%
drop HbA1c
4 Better in HbA1c can reduce
control long-term
is associated withdiabetes complications
reductions in long-term43% Lower
health extremity amputation
complications or fatal
Every 1% drop in
peripheral vascular disease 37% Microvascular disease 19% Cataract extraction 14% Myocardial
infarction 16% Heart failure 12% Stroke UKPDS 35: Stratton et al. BMJ 2000;32:405–12
5. 5. 5 The worldwide challenge of glycaemic control: mean HbA1C in type 2 diabetes Canada 7.36–
8.7%11 Latin America 7.6%1 US 7.2%7 China 9.5%11 India 8.7–9.6%9,11 Japan 7.05–9.6%11 Korea
7.9–8.7%4 Russia 9.6%11 Spain 9.2%8 Sweden 8.7%3 Turkey 10.6%3 UK 8.510–9.8%2 Germany
8.42–9.2%8 Greece 8.911–9.7%3,8 Italy 8.4%11 Poland 9.0%11 Portugal 9.7%3 Romania 9.9%3 1.
Lopez Stewart et al. Rev Panam Salud Publica 2007;22:12–20; 2. Kostev & Rathmann Primary Care
Diabetes 2013;7:229–33; 3. Oguz et al. Curr Med Res Opin 2013;29:911–20; 4. Ko et al. Diabet Med
2007;24:55–62; 5. Arai et al. Diabetes Res Clin Prac 2009;83:397–401; 6. Harris et al. Diabetes Res
Clin Pract 2005;70:90–7; 7. Hoerger et.al. Diabetes Care 2008;31:81–6; 8. Liebl et al. Diabetes Ther
2012;3:e1–10; 9. Shah et al. Adv Ther 2009;26:325–35; 10. Blak et al. Diabet Med 2012;29:e13–20;
11. Valensi et al. Int J Clin Pract 2008;62:1809–19
6. 6. Progressive treatment should follow progressive disease
7. 7. 7 Type 2 diabetes is a progressive disease HOMA, homeostasis model assessment Adapted from:
UKPDS 16. Diabetes 1995;44:1249–58
8. 8. 8 30 49 55 60 70 70 51 45 40 30 <7.3 7.3-6.4 8.5-9.2 9.3-10.2 >10.2 Recommended insulin therapy
considers the contribution of FPG and PPG in driving HbA1c levels Contributiontooverall
hyperglycaemia(%) HbA1c value quintiles (%) FPG PPG • The relative contribution of PPG becomes
increasingly important for maintaining overall glycaemic control with lower HbA1c 1 • When
HbA1cglycaemic
can reducegoals
l... are not obtained despite successful basal insulin dose titration, treatment should be
intensified by the addition of a prandial or biphasic insulin2 FPG, fasting plasma glucose; PPG,
postprandial glucose 1. Monnier et al. Diabetes Care 2003;26:881-5; 2. Swinnen et al Diabetes Care
2009;32 (Suppl. 2):S253-9
9. 9. 9 The addition of mealtime coverage is needed when basal insulin is no longer enough 8:00 75
8:004:00 12:00 16:00 20:00 24:00 4:00 50 25 0 Time PlasmaInsulin (μU/mL) Basal Insulin
DinnerLunch Breakfast This may lead to hypoglycaemia if food changes or meals are missed Mealtime
insulin response is missing; high postprandial readings at every meal Garber et al. DOM
2009;11(Suppl. 5):14-8
10. 10. 10 Insulin optimisation and intensification should follow disease progression Betacell function(%)
Treatment optimisation and intensification Lifestyle + OADs Basal and 1-4 bolus Or Premix Basal
insulin + OADs Titrate dose to reach/maintain glycaemic targets Intensify for mealtime insulin
coverage Initiate Optimise Intensify Schematic diagram adapted from Kahn et al. Diabetologia
2003;46:3–19; Inzucchi et al. Diabetologia 2012;55:1577-96
11. 11. ADA/EASD 2015 – guidelines for managing hyperglycaemia
12. 12. Rationale for combining basal and bolus insulin in a single injection • Type 2 diabetes is a
progressive disease • The addition of insulin to provide mealtime coverage is needed when basal
insulin is no longer enough1 • Existing basal and bolus regimens offer basal and precise postprandial
glucose control but as separate injections2,3 • A combination of basal and bolus insulin could allow for
a simple regimen with fewer injections 2 1. Garber et al. Diabetes Obes Metab 2009;11(suppl 5):14–
18; 2. Inzucchi et al. Diabetes Care 2012;35:1364–1379; 3. Nathan et al. Diabetes Care 2009;32:193–
203
13. 13. 1. Summary of Product Characteristics (SPC) 2. Jonassen I et al., Ultra-long acting insulin degludec
can be combined with rapid-acting insulin aspart in a soluble co-formulation (Abstract). J Pept Sci
2010;16:32 3. De Rycke A et al., Degludec – First of a New Generation of Insulins. European
Endocrinology 2011;7(2):84–7 …basal insulin with an ultra-long duration of action, degludec, and a
well-established mealtime insulin, aspart 1,2,3 In one pen, for people with type 2 diabetes IDegAsp is
the first combination of two Insulin analogues…
14. 14. Co-formulation vs premixed preparation Preparation Co-formulation Premixed preparation

Definition Formulation of two separate components, which maintain distinct identity Mixture of two
components, which are unable to maintain distinct identity Appearance Clear Cloudy Proportion Pre-
determined Pre-determined Kinetics/Dynamics Both components maintain distinct PK/PD profiles
PK/PD profile of both components may merge Scope Allows co-formulation of separate classes of
drugs Does not allow mixing of different classes of drugs Examples degludec+ aspart;
degludec+liraglutide; glargine+lixisenatide Biphasic human Insulin / Insulin aspart/ lispro
15. 15. Insulin detemir and insulin glargine cannot be co-formulated with commercially available rapid-
acting analogues 1. Lantus® US Prescribing Information. Sanofi April 2010; 2. Jonassen et al. Pharm
Resworldwide
5 The 2012;29:2104–2114
challenge ofInsulin detemir2
glycaemic Insulin
control: detemir
mean HbA1C Insulin aspart
in type Mixed Canada
2 diabetes hexamers pH 7.00.0
7.36–8.7%11
14.0 Insulin glargine is soluble at pH 4 Rapid-acting analogues soluble at pH 7.4 Insulin glargine1
16. 16. • Forms stable dihexamers and does not interact with hexamers of insulin aspart • Has a flat and
stable glucose-lowering effect at steady state • Formulated at neutral PH similar to rapid-acting insulin
analogues Ultra-long-acting insulin degludec- candidate for co-formulation
17. 17. Half-life of insulin degludec is twice as long as that of insulin glargine 1. Heise et al. Diabetes Obes
Metab 2012;14:944–950; 2. Heise et al. Diabetes 2012;61(suppl 1):A259; 3. Heise et al. Diabetes Obes
Metab 2012;14:859–864 Flat time-action profile in type 2 diabetes at steady state1 Day-to-
dayvariability (coefficientofvariation%) Variability in glucose-lowering effect over 24 hours at steady
state3 IDeg variability is four-fold lower than IGlar 54320 1 6 Days since first dose
IDegserumconcentration ProportionofDay6level (%) 0 Type 2 diabetes 0 1 2 3 4
ProportionofDay4level (%) 120 0 Days since first dose Type 1 diabetes Insulin degludec concentration
reaches steady state in 3 days2 120 The mean half-life of insulin degludec is 25.4 hours compared with
insulin glargine, which has a half- life of 12.1 hours1
18. 18. IDegAsp A soluble co-formulation of insulin degludec and insulin aspart Havelund et al. Pharm
Res 2015 Jan 8 [Epub ahead of print] IAsp hexamers Phenol1 IDeg dihexamers IDeg multihexamers
IAsp monomers No phenol1 Slow dissociation Subcutis Capillary Rapid dissociation IDeg IAsp In
subcutaneous depot IDeg di-hexamers (70%) IAsp hexamers (30%) Formulation It is not a premix
insulin
19. 19. 19 Ryzodeg® 0.3 U/kg BID Injections The flat and stable basal coverage beyond 24 hours of
Latin America
insulin degludec
7.6%1 US Time
7....(in hours) Glucoseinfusionrate (mg/kg*min)intype1patients The mealtime
control of insulin aspart 8 6 4 2 0 0 24 Ryzodeg® dosed twice daily for type 2 patients provides basal
coverage and control for two main meals13,14,19 Simulation of glucose-lowering effect of Ryzodeg®
dosed twice daily19 Please see study design 1 on slide 26
20. 20. IDegAsp shows distinct prandial and basal glucose lowering effects compared with BIAsp30 n=22
for IDegAsp; n=24 for BIAsp 30 T1DM, type 1 diabetes 1. Heise et al. Diabetes Ther 2014;5:255–265;
2. Heise et al. Diabetes 2013;62 (suppl 1):A241 (abstract 947-P) Mean glucose infusion rates for
IDegAsp and BIAsp 30 in subjects with T1DM Dose: 0.6 U/kg IDegAsp (steady state)110 0
Glucoseinfusionrate(mg/([kg•min]) 4 8 12 16 8 6 4 0 2 Time since injection (hours) 20 24
Glucoseinfusionrate(mg/[kg•min]) Time since injection (hours) BIAsp 30 (single dose)210 0 4 8 12 16
8 6 4 0 2 20 24 Shoulder effect
21. 21. 21Results from studies NN2004-1418 and NN5401-1959 in patients with T1DM Profile: IDegAsp
vs BIAsp 30 & BHI30 BHI 30 IDegAsp 11 Nominal time (h) 0 1 2 3 4 5 6 7 8 9 10 12 13 14 15 16 17
18 19 20 21 22 23 24 Glucoseinfusionrate (mg/kg/min) 0 1 2 3 4 5 6 7 8 9 10 BIAsp 30
22. 22. PK profiles of IDeg were similar for subjects with normal and impaired renal function • Kiss I et al.
Clin Pharmacokinet. 2014; 53: 175–183 Mean total exposure to IDeg (AUCIDeg,0-120) following
single dose of IDeg in different renal function groups 1,000,000 100,000 10,000 Normal Renal
function group Mild Moderate Severe Creatinine clearance (mL/min) 10 100 1000 AUCIDeg,0–
120h,SD
23. 23. IDeg pharmacokinetics at steady state are similar to simulated data from hepatic and renal
impairment studies • 1. Kiss I et al. Clin Pharmacokinet. 2014; 53: 175–1832. Arold G et al. Clin Drug
Investig. 2014 Feb;34(2):127-3 IDeg at steady state1 Simulated steady state in renal impairment1
Simulated steady state in hepatic impairment2 0 0 4 8 12 16 20 24 2000 4000 6000 8000 10000 Renal
function group Normal Mild Moderate Severe Hepatic function group Normal Child–Pugh A Child–
Pugh B Child–Pugh C Time since injection (hours) 0 0 4 8 12 16 20 24 2000 4000 6000 8000 10000
Insulindegludecserumconcentration(pmol/L) 0 0 4 8 12 16 20 24 2000 4000 6000 8000 10000 IDeg 0.4
U/kg
24. 24. Total daily starting dose for IDegAsp is 10 units with main meal(s) followed by individual dosage
adjustments Type 2 diabetes Type 1 diabetes The recommended starting dose of IDegAsp is 60–70% of
the total daily insulin requirements IDegAsp should be used once daily with the main meal and
short-/rapid-acting insulin should be used at the remaining meals, followed by individual dosage
adjustments Dosing of IDegAsp: Initiation Ryzodeg® Summary of Product Characteristics 2013
25. 25. Patients can be converted to IDegAsp at the same total insulin dose as the patient’s previous total
daily dose1 Patients can be converted unit-to-unit to IDegAsp dosed twice daily at the same total
insulin dose as the patient’s previous total daily dose1 OD 1:1 OD Basal/Premix IDegAsp BID 1:1
≥BID Basal/Premix IDegAsp Dosing of IDegAsp: Transfer from other insulins Ryzodeg® Summary of
Product Characteristics 2013
26. 26. Phase 3 BID: Titration algorithm1,2 Pre-breakfast/pre-main evening meal plasma glucose*
Adjustment
Progressive mmol/L
treatment mg/dL
should U <3.1†
follow <56† –4disease
progressive (If dose >45U, reduce by 10%) 3.1–3.9† 56–69† –2 (If
dose >45U, reduce by 5%) 4.0–4.9 70–89 0 5.0–6.9 90–125 +2 7.0–7.9 126–143 +4 8.0–8.9 144–161
+6 ≥9.0 ≥162 +8 *Mean of three consecutive days’ measurements; †Unless there is an obvious
explanation for the low value, such as a missed meal 1. Fulcher et al. IDF 2013. Poster P-1399; 2.
Christiansen et al. IDF 2013. Poster P-1395
27. 27. Ramadan Guidelines for Patients with Diabetes Mellitus
28. 28. Fasting is a worldwide custom practiced for religious and cultural reasons122 28 Religion
Examples of fasting practices2–5 Muslim Ramadan: fasting during daylight hours for 29–30 days2,3
Jewish Yom Kippur and Tish’ah B’av: single days of fasting4 Hinduism Single days of fasting4
Christianity Ash Wednesday and Good Friday: single days of fasting4 Mormon Fasting once a month
for a single day5 Healthy adult Muslims fasting during the month of Ramadan abstain from food,
water, or use of oral medications between dawn and sunset for 29–30 days every year2,3 1Fasting can
range from restricting certain foods to complete abstinence from all food and drink: 1Fazel M . J R Soc
Med 1998;91:260–63; 2Al-Arouj M et al. Diabetes Care 2010;33:1895–902; 3Salti I et al. Diabetes
Care 2004;27:2306–11; 4Green V. Br J Nursing 2004;13:658– 62; 5Horne BD et al. Am J Cardiol
2008; 102:814–19.
29. 29. A large number of Muslim patients with diabetes fast during Ramadan 29 • The global prevalence
of diabetes is projected to increase in emerging economies, including those with large Muslim
populations4,5 • The pattern of daytime fasting and night-time meals and use of anti-diabetic treatment
increases the risk of complications, including hypoglycaemia in patients with diabetes2,3 • Although
the consensus from religious and medical leaders is that Muslims with diabetes are generally not
obliged to fast6 many choose to do so2,3 1.6 billion (2010) 2.2 billion (2030) Global Muslim
population1 1The Pew Forum on Religion & Public Life. http://www.pewforum.org/The-Future-of-the-
Global-Muslim-Population.aspx (Accessed March 2013); 2Al-Arouj M et al. Diabetes Care
2010;33:1895–902; 3Salti I et al. Diabetes Care 2004;27:2306–11; 4IDF Diabetes Atlas 5th edition.
www.idf.org/diabetesatlas/5e/the-global-burden (Accessed March 2013); 5Whiting DR et al. Diabetes
Res Clin Pract 2011; 94: 311–21; 6Beshyah SA. Ibnosina J Med Biomed Sci 2009;1:58–60
30. 30. There are risks associated with fasting in patients with diabetes 30 Hypoglycaemia: due to
decreased or irregular food intake together with the use of antidiabetic medication;1–3 this has a
negative impact on patient morbidity, mortality & QoL3–9 Hyperglycaemia: due to excessive glycogen
breakdown, increased gluconeogenesis and reduced doses of antidiabetic medication1,2 Dehydration:
caused by limited fluid intake, as well as osmotic diuresis produced by hyperglycaemia1 Ketoacidosis:
due to increased ketogenesis1,2 Risks of fasting in patients with diabetes : 21 3 4 1Al-Arouj M et al.
Diabetes Care 2010;33:1895–902;2Salti I et al. Diabetes Care 2004;27:2306–11; 3Amiel SA et al.
Diabet Med 2007;25:245–54; 4Whitmer RA et al. JAMA 2009;301:1565–72; 5Bonds DE et al. BMJ
2010;340:b4909; 6Barnett AH. Curr Med Res Opin 2010;26:1333–42; 7Foley JE et al. Vasc Health
Risk Manag 2010;6:541–8; 8Begg IS et al. Can J Diabetes 2003;27:128–40;
31. 31. 31 1Begg IS et al. Can J Diabetes 2003;27:128–40 2Bonds DE et al. BMJ 2010;340:b4909;
3Barnett AH. Curr Med Res Opin 2010;26:1333–42; 4Jönsson L et al. Value Health 2006;9:193–8;
5Foley JE et al. Vasc Health Risk Manag 2010;6:541–8; 6Whitmer RA et al. JAMA 2009;301:1565–
72; 7McEwan P et al. Diabetes Obes Metab 2010;12:431–6 The consequences of hypoglycaemia
Hypoglycaemia Cardiovascular complications3 Weight gain by defensive eating5 Coma3 Increased
risk of dementia6 Hospitalization costs4 Loss of consciousness3 Increased risk of seizures3 Death2,3
Increased risk of car accident1 Reduced quality of life7 31
32. 32. Ramadan Guidelines for patient with Type I Diabetes mellitus Very High Risk : • Brittle DM. •
Patients on insulin pump • Patients on multiple insulin injections per day • Ketoacidosis or severe
hypoglycaemia • Advance micro vascular or macro vascular complication.
33. 33. Consensus From International Meetings On Fasting TYPE 1 DIABETES • Do not have to fast • If
insistent on fasting require very careful supervision if on Basal Bolus. (Someone experienced and
knowledgeable in Diabetes Management.)

34. 34. Fast with risk • Well controlled DM • No DKA • No Recent hypoglycemia • Not more than 2
injections per day
35. 35. Ramadan guidelines for Type 2 DM Very high risk: • Severe hypoglycemia within the Last 3
months prior to Ramadan patient with a history of recurrent hypoglycemia. • Patient with
hypoglycemia unawareness/alertness problem. • Patient with sustained poor glycemic control . •
Ketoacidosis within the last 3 months prior to Ramadan. • Hyperosmolar hyperglycemic coma within
the last 3 months prior to Ramadan & Acute illness. • Patient on dialysis.
36. 36. High Risk: • Patient with renal insufficiency • Patient with advance macrovascular complications -
Coronary,
7 Type cerebrovascular
2 diabetes & severe
is a progressive diseaseretinopathy • Autonomicmodel
HOMA, homeostasis neuropathy- Gastro
assessment paresisfrom:
Adapted and postural
UKPDS
hypotension • Patient living alone and treated with multiple insulin injection or sulfonylureas. • Old age
with ill health. Ramadan guidelines for Type 2 DM
37. 37. Categories of risks in patients with type 1 or type 2 diabetes who fast during Ramadan (ADA
Position Statement on Ramadan ) Moderate risk • Well-controlled patients treated with short-acting
insulin, secretagogues such as repaglinide or nateglinide Low risk • Well-controlled patients treated
with diet alone, metformin, or a thiazolidinedione who are otherwise healthy Physiological condition: •
Pregnancy, Lactation
38. 38. Co-existing major medical conditions • Acute peptic ulcer, • Severe bronchial asthma, Pulmonary
Tuberculosis, • Cancer • Overt cardiovascular diseases- - Recent MI, Sustained angina. • Hepatic
dysfunction.
39. 39. Guideline for Ramadan Educational Counseling • Plan at least 3 months before • Education of
diabetic patients and their families • Must focus on: - The situations contraindicating fasting -
Treatment of diabetes and it’s modification: *Meal planning *physical activities *medication -
Importance and tool of self monitoring skills and adjustment • Must insist on: - The risk of acute
complication and means to prevent them
40. 40. Lifestyle management: Physical activity : exercise 1. Reduce physical activities during the day 2.
Physical exercise can be performed about one hour after Iftaar. 3. Taraweih prayer should be
considered a part of daily exercise program.
41. 41. Dietary assessment: Nutrition • Ensure adequate hydration and electrolyte • No significant
16. Diabetes
difference,
1995;44:124...
from a healthy and balanced diet. • Take sahur close to predawn time. • Change in the
schedule, amount and composition of meals according to individual choice. • Plan the diet chart
considering carb counting according to patient habit and social customs. • Keep the daily total calorie
same, divide into 2/3 schedule according to choice and tradition
42. 42. Dietary guidelines: • Divide your food in to 2-3 meal – - Iftaar, Dinner & Sahur/predawn. • Limit
the amount of sweet food taken at iftaar – - Jelapi, laddoo, burfi, sweets, sugar containing sarbat • Limit
fried food- - Samosas , pakoras, puri, parata, fried kababs. • Choose sugar free type drinks and drink
plenty water. Use sugar free sweetner where needed-Canderal, Equal, Sweetex • Fill up on starchy food
during-Dinner and Sahur –rice, capati, nan, vegetables, dhal, fish, meat, geg, milk, yoghurt and fruits.
43. 43. Before Ramadan During Ramadan • IdegAsp insulin twice daily, e.g., 30 units in morning and 20
units in evening • Use the usual morning dose at the sunset meal (Iftaar) and half the usual evening
dose at predawn (Sahur), e.g. IdegAsp insulin, 30 units in evening and 10 units in morning.
Recommended changes to treatment regimen in patients with type 2 diabetes who fast during Ramadan
(ADA Position Statement on Ramadan ) • Patients’ on Ryzodeg®
44. 44. Consensus From International Meetings On Fasting If on IdegAsp+ Metformin • Give Iftaar
(evening dose) as same as for breakfast premixed dose but • Take Metformin at Sahur (early morning
meal) and Iftaar and patient may be okay and may not require premixed at Sahur • But if midday blood
sugar control not good, add premixed 50% of normal evening dose at Sahur (early morning meal)
45. 45. Before Ramadan IdegAsp 30/70 twice daily Morning Dinner 30 U 20 U During Ramadan Iftaar
Dinner Sahur M 30-full dose 0 D 10- ½ dose Ryzodeg®dosing Patient on insulin
46. 46. Monitoring during Ramadan • Blood glucose level during the fast - to recognize subclinical hypo
and hyperglycemia. • 2hour post Sahur and one/two hour pre Iftaar - to pick subclinical hypoglycemia.
• 2 hour post Iftar/ Dinner - to pick sub clinical hyperglycemia Adjust insulin dose 3 days interval Pre-
iftaar- Adjust Detemir/Glagine Mid day-Adjust NPH 2 h Post iftaar-Adjust iftar aspart 2 h Post dinner-
Adjust dinner aspart 2 h Post sahur-Adjust sahur aspart
47. 47. Monitoring during Ramadan • If blood glucose is noted to be low, the fast must be broken. • If
blood glucose > 300 mg /dl or, 16.66 m.mol/dl, - ketones in urine should be checked.
48. 48. Consensus From International Meetings On Fasting Monitoring • Finger stick BG after Iftaar and
before sahur • BG if feeling bad (low) • Terminate fast if BS below 60 mg/dl or over 400 mg/dl • No
exercise before Iftaar • Drink plenty of water at iftaar and Sahur

49. 49. 49 Hypoglycaemia continues to be a main obstacle for HCPs to effectively treat with insulin
Results from the GAPP™ study GAPP™ • A global internet survey of patient and physician beliefs
regarding insulin therapy • n=1250 physicians GAPP, Global Attitudes of Patients and Physicians;
HCP, health care provider Peyrot et al. Diabetic Med 2012;29:682–9 72% 79% 0 20 40 60 80 100
Percentage I would treat my patients more aggressively if there was no concern about hypoglycaemia
p<0.05 Diabetes specialistsPrimary care physicians
50. 50. Fear of hypoglycaemia reduces patient adherence and may affect glycaemic control Many patients
decrease their insulin dose following a hypoglycaemic event 74% 79% 43% 58% 0% 20% 40% 60%
8 3080%
49 55 100% Non-severe
60 70 episodes
70 51 45 40 30 <7.3Severe
7.3-6.4episodes
8.5-9.2 Patients
9.3-10.2modifying insulin doseinsulin
>10.2 Recommended Type 1therapy
diabetes Type
2 diabetes Total patient sample, n=335 (type 1 diabetes, n=202; type 2 diabetes, n=133) Leiter et al.
Can J Diabetes 2005;29:186–92
51. 51. 51 Hypoglycaemia is a problem with diabetes therapy 0% 5% 10% 15% 20% 25% 30% 35% 0
5,000 10,000 15,000 20,000 25,000 30,000 35,000 Percentageofestimated numberofhospitalisations
Estimatednumberof hospitalisations 95% of all endocrine emergency hospitalisations in people >65
years are caused by hypoglycaemia Medications most commonly associated with emergency
hospitalisation Data given are number and percentage of annual national estimates of hospitalisations.
Data from the NEISS-CADES project. ER visits n=265,802/Total cases n=12,666. ER, emergency
room Budnitz et al. N Engl J Med 2011;365:2002–12
52. 52. 52 52 Presentation title Date
53. 53. 53 Patient might get confused to manage diabetes during Ramadan 53 Presentation title Date
54. 54. Novo Nordisk® introduces A novel co-formulation insulin analogue for managing Diabetes
Mellitus
55. 55. BOOST: INTENSIFY PREMIX I Hypoglycaemia SAS. Comparisons: Estimates adjusted for
multiple covariates Severe hypoglycaemia occured in 3.1% (7/224) of patients on IDegAsp (rate 0.09
episodes/PYE) compared to 7.2% (13/222) of patients on BIAsp 30 (rate 0.25 episodes/PYE), IDegAsp
vs. BIAsp 30 rate ratio: 0.50 Fulcher et al. IDF 2013. Poster P-1399 73% lower rate with IDegAsp,
p<0.0001 32% lower rate with IDegAsp, p=0.0049 Time (weeks) 0 1 2 3 4 5 6 7 8 0 2 4 6 8 10 12 14
16 18 20 22 24 26 Confirmedhypoglycaemia (cumulativeeventsperpatient) Overall confirmed
considers
hypoglycaemia
the contribution...
Confirmed nocturnal hypoglycaemia IDegAsp BID (n=224) BIAsp30 BID (n=222) 0.0
0.2 0.4 0.6 0.8 1.0 1.2 1.4 0 2 4 6 8 10 12 14 16 18 20 22 24 26 Nocturnalconfirmed hypoglycaemia
(cumulativeeventsperpatient) Time (weeks)
56. 56. BOOST: INTENSIFY ALL Hypoglycaemia SAS. Comparisons: Estimates adjusted for multiple
covariates Severe hypoglycaemia occured in 1.4% (4/279) of patients on IDegAsp (rate 0.05
episodes/PYE) compared to 1.4% (2/141) of patients on BIAsp 30 (rate 0.03 episodes/PYE)
Christiansen et al. IDF 2013. Poster P-1395 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 0 2 4 6 8 10 12 14
16 18 20 22 24 26 Confirmedhypoglycaemia (cumulativeeventsperpatient) Similar estimated rate in the
2 trial arms (ns) Time (weeks) Confirmed hypoglycaemia 33% lower rate with IDegAsp (ns) 0.0 0.1
0.2 0.3 0.4 0.5 0.6 0.7 0.8 0 2 4 6 8 10 12 14 16 18 20 22 24 26 Nocturnalconfirmedhypoglycaemia
(cumulativeeventsperpatient) Time (weeks) Confirmed nocturnal hypoglycaemia IDegAsp BID
(n=279) BIAsp30 BID (n=141)
57. 57. 1.28% HbA1c Reduction Treatment difference: Non-inferior Ryzodeg® successfully achieved
HbA1c reductions in a multinational study…13,14 Mean HbA1c vs BIAsp 30 in a type 2 diabetes
study13,14 6.5 7.0 8.0 HbA1c(%) 0 0 2 4 6 8 10 12 14 16 18 20 22 24 BIAsp 30 BID Ryzodeg® BID
7.5 8.5 9.0 7.1% 26 Time (weeks) In a type 2 diabetes study • Similar reductions in HbA1c vs.
BIAsp30 BID as expected in treat-to-target study14 Ref.: 13. Ryzodeg® [summary of product
characteristics]. Bagsværd, Denmark: Novo Nordisk A/S; 2014. 14. Fulcher G, Christiansen JS,
Bantwal G, et al; on behalf of the BOOST: Intensify Premix I Investigators. Comparison of insulin
degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a
phase 3a, randomized, treat-to- target trial. Diabetes Care. 2014;37(8): 2084–2090.
9 The addition of mealtime coverage is needed when basal insulin is no longer enough 8:00 75 8:004:00
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Rationale for combining basal and bolus insulin in a single injection • Type 2 diabetes is a progressive
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disease • The add...
1. Summary of Product Characteristics (SPC) 2. Jonassen I et al., Ultra-long acting insulin degludec can be
combined with ...
Co-formulation vs premixed preparation Preparation Co-formulation Premixed preparation Definition
Formulation of two separ...
Insulin detemir and insulin glargine cannot be co-formulated with commercially available rapid-acting
analogues 1. Lantus®...
• Forms stable dihexamers and does not interact with hexamers of insulin aspart • Has a flat and stable
glucose-lowering e...
Half-life of insulin degludec is twice as long as that of insulin glargine 1. Heise et al. Diabetes Obes Metab
2012;14:944...
IDegAsp A soluble co-formulation of insulin degludec and insulin aspart Havelund et al. Pharm Res 2015
Jan 8 [Epub ahead o...
19 Ryzodeg® 0.3 U/kg BID Injections The flat and stable basal coverage beyond 24 hours of insulin
degludec Time (in hours)...
IDegAsp shows distinct prandial and basal glucose lowering effects compared with BIAsp30 n=22 for
IDegAsp; n=24 for BIAsp ...
21Results from studies NN2004-1418 and NN5401-1959 in patients with T1DM Profile: IDegAsp vs
BIAsp 30 & BHI30 BHI 30 IDegA...
PK profiles of IDeg were similar for subjects with normal and impaired renal function • Kiss I et al. Clin
Pharmacokinet. ...
IDeg pharmacokinetics at steady state are similar to simulated data from hepatic and renal impairment
studies • 1. Kiss I ...
Total daily starting dose for IDegAsp is 10 units with main meal(s) followed by individual dosage
adjustments Type 2 diabe...
Patients can be converted to IDegAsp at the same total insulin dose as the patient’s previous total daily
dose1 Patients c...
Phase 3 BID: Titration algorithm1,2 Pre-breakfast/pre-main evening meal plasma glucose* Adjustment
mmol/L mg/dL U <3.1† <5...
Ramadan Guidelines for Patients with Diabetes Mellitus
Fasting is a worldwide custom practiced for religious and cultural reasons122 28 Religion Examples of
fasting practices2–5...
A large number of Muslim patients with diabetes fast during Ramadan 29 • The global prevalence of
diabetes is projected to...
There are risks associated with fasting in patients with diabetes 30 Hypoglycaemia: due to decreased or
irregular food int...
31 1Begg IS et al. Can J Diabetes 2003;27:128–40 2Bonds DE et al. BMJ 2010;340:b4909; 3Barnett AH.
Curr Med Res Opin 2010;...
Ramadan Guidelines for patient with Type I Diabetes mellitus Very High Risk : • Brittle DM. • Patients on
insulin pump • P...
Consensus From International Meetings On Fasting TYPE 1 DIABETES • Do not have to fast • If insistent
on fasting require v...
Fast with risk • Well controlled DM • No DKA • No Recent hypoglycemia • Not more than 2 injections per
day
Ramadan guidelines for Type 2 DM Very high risk: • Severe hypoglycemia within the Last 3 months prior
to Ramadan patient w...
High Risk: • Patient with renal insufficiency • Patient with advance macrovascular complications -
Coronary, cerebrovascul...
Categories of risks in patients with type 1 or type 2 diabetes who fast during Ramadan (ADA Position
Statement on Ramadan ...
Co-existing major medical conditions • Acute peptic ulcer, • Severe bronchial asthma, Pulmonary
Tuberculosis, • Cancer • O...
Guideline for Ramadan Educational Counseling • Plan at least 3 months before • Education of diabetic
patients and their fa...
Lifestyle management: Physical activity : exercise 1. Reduce physical activities during the day 2. Physical
exercise can b...
Dietary assessment: Nutrition • Ensure adequate hydration and electrolyte • No significant difference, from
a healthy and ...
Dietary guidelines: • Divide your food in to 2-3 meal – - Iftaar, Dinner & Sahur/predawn. • Limit the
amount of sweet food...
Before Ramadan During Ramadan • IdegAsp insulin twice daily, e.g., 30 units in morning and 20 units in
evening • Use the u...
Consensus From International Meetings On Fasting If on IdegAsp+ Metformin • Give Iftaar (evening
dose) as same as for brea...
Before Ramadan IdegAsp 30/70 twice daily Morning Dinner 30 U 20 U During Ramadan Iftaar Dinner
Sahur M 30-full dose 0 D 10...
Monitoring during Ramadan • Blood glucose level during the fast - to recognize subclinical hypo and
hyperglycemia. • 2hour...
Monitoring during Ramadan • If blood glucose is noted to be low, the fast must be broken. • If blood
glucose > 300 mg /dl ...
Consensus From International Meetings On Fasting Monitoring • Finger stick BG after Iftaar and before
sahur • BG if feelin...
49 Hypoglycaemia continues to be a main obstacle for HCPs to effectively treat with insulin Results from
the GAPP™ study G...
Fear of hypoglycaemia reduces patient adherence and may affect glycaemic control Many patients
decrease their insulin dose...
51 Hypoglycaemia is a problem with diabetes therapy 0% 5% 10% 15% 20% 25% 30% 35% 0 5,000
10,000 15,000 20,000 25,000 30,0...
52 52 Presentation title Date
53 Patient might get confused to manage diabetes during Ramadan 53 Presentation title Date
Novo Nordisk® introduces A novel co-formulation insulin analogue for managing Diabetes Mellitus
BOOST: INTENSIFY PREMIX I Hypoglycaemia SAS. Comparisons: Estimates adjusted for multiple
covariates Severe hypoglycaemia ...
BOOST: INTENSIFY ALL Hypoglycaemia SAS. Comparisons: Estimates adjusted for multiple covariates
Severe hypoglycaemia occur...
1.28% HbA1c Reduction Treatment difference: Non-inferior Ryzodeg® successfully achieved HbA1c
reductions in a multinationa...
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Published on Jun 14, 2015

Insulin degludec/insulin aspart- an overview of co-formulation insulin

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Ryzodeg presentation in ramadan by dr shahjada selim

14. 14. Co-formulation vs premixed preparation Preparation Co-formulation Premixed preparation

knowledgeable in Diabetes Management.)

exercise before Iftaar • Drink plenty of water at iftaar and Sahur

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Diabetes and ramadan ﬁnal publication

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Practical Management of Type 2 Diabetes during the Holy month of Ramadan

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Bangladeshi brief menu

Insulin intensiﬁcation : the usage of premixed insulin after basal fails

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disease • The add...

combined with ...

Co-formulation vs premixed preparation Preparation Co-formulation Premixed preparation Deﬁnition

Formulation of two separ...

Jan 8 [Epub ahead o...

degludec Time (in hours)...

IDegAsp; n=24 for BIAsp ...

BIAsp 30 & BHI30 BHI 30 IDegA...

studies • 1. Kiss I ...

adjustments Type 2 diabe...

dose1 Patients c...

mmol/L mg/dL U <3.1† <5...

Ramadan Guidelines for Patients with Diabetes Mellitus

diabetes is projected to...

irregular food int...

Curr Med Res Opin 2010;...

insulin pump • P...

on fasting require v...

to Ramadan patient w...

Statement on Ramadan ...

Tuberculosis, • Cancer • O...

patients and their fa...

exercise can b...

a healthy and ...

amount of sweet food...

evening • Use the u...

dose) as same as for brea...

Sahur M 30-full dose 0 D 10...

glucose > 300 mg /dl ...

the GAPP™ study G...

decrease their insulin dose...

10,000 15,000 20,000 25,000 30,0...

52 52 Presentation title Date

Diabetes & ramadan (2)