NO Reference Parameters of Baseline Result Parameters of Safety Result

Efficacy
1. J (1)  Dapagliflozin 1. Adverse event  gagal mencapai target glikemik
1. HbA1c ≥8% -0,8% [8,7 mmol / mol] dengan dapagliflozin > placebo
 Plasebo  infeksi genital dapagliflozin (9,8%),
0,0% [0,3 mmol / mol] plasebo (0,4%)
 infeksi saluran kemih seimbang
dapagliflozin (6,7%) dan plasebo
(6,2%).
2. Total body  Dapagliflozin -2,1 2. Lab values
weight  Placebo -0,3 kg 3. Pulse
4. ECG
3. FPG  Dapagliflozin
5. Hypoglicemia
-24,1 mg / dL [-1,3 mmol / L]
events
 Plasebo 6. GFR
3,8 mg / dL [0,2 mmol / L] 7. Creatinin clirence
8. Physical
examination

4. SBP ≥130mmHg
5. PPG
2. J (2) 1. HbA1c <7.0%  Canagliflozin 100 mg (-0,60%)
 Canagliflozin 300 mg (-0,73%)
↓ up to <6.5% for both
canagliflozin doses
<8%, ≥8%,  <65 years (placebo-subtracted
<9% mean changes of −0.65% and
subgroups −0.82% )
 >65 years (placebo-subtracted
mean changes of −0.45% and
−0.50% )
3. FPG  canagliflozin 100mg
−25.5 mg/dL (−1.4 mmol/L)
 canagliflozin 300mg
−27.7 mg/dL (−1.5 mmol/L)
4. BW  canagliflozin 100mg
−2.3% (−2.1 kg)
 canagliflozin 300mg
−3.0% (−2.7 kg)
Respectively (P , 0.001 for both
canagliflozin doses)
5. Systolic BP  Canagliflozin 100mg
(−4.6 mmHg)
 Canagliflozin 300 mg
(−7.9 mmHg)
Respectively (P, 0.001) for both
canagliflozin doses
6. HDL-C  Canagliflozin 100 mg (5.3%)
 Canagliflozin 300 mg (4.7%)
7. Fasting 
triglyceride
levels
8.
Tambahan :  Canagliflozin 100 mg
1. Diastolic BP −1.6 mmHg
 Canagliflozin 300 mg
−3.2 mmHg
2. LDL-C
3. LDL-C/
HDL-C ratio
4. Non HDL-C