Rosenstock (2013) | Randomized Double-blind Placebo- controlled | 495 T2DM (250M; 245F) | Screening Period: over 1 week
Oral (non-metformin) AHA Washout Period (if applicable): 4 weeks
Placebo Run-in Period: 2 weeks
Double-blind Treatment Period: 12 weeks
Group A: placebo once daily + MET
Group B: EMPA 5 mg once daily + MET
Group C: EMPA10 mg once daily + MET
Group D: EMPA 25 mg once daily + MET
Group E: Open-label SITA100mg once daily + MET
Follow-up Visit: 1 week after last treatment | HbA1C (%) at 12 Weeks | |||
Baseline Mean ± SD | Adjusted Mean Change | Difference vs. PBO | |||||
(95% CI) | (95% CI) | ||||||
PBO | 8.0 ± 0.7 | 0.15 | - | ||||
(N = 71) | (−0.00, 0.30) | ||||||
EMPA 1 mg | 7.8 ± 0.7 | −0.09 | - | ||||
(N = 71) | (−0.24, 0.07) | ||||||
EMPA 5 mg | 8.0 ± 0.7 | −0.23* | - | ||||
−71 | (−0.39, −0.08) | ||||||
EMPA 10 mg | 7.9 ± 0.7 | −0.56** | - | ||||
(N = 71) | (−0.71, −0.41) | ||||||
EMPA 25 mg | 8.1 ± 0.8 | −0.55** | - | ||||
(N = 70) | (−0.70, −0.40) | ||||||
EMPA 50 mg | 7.9 ± 0.7 | −0.49** | - | ||||
(N = 70) | (−0.64, −0.33) | ||||||
SITA | 8.1 ± 0.9 | −0.45** | - | ||||
(N = 71) | (−0.65, −0.25) | ||||||
*p ≤ 0.001 vs. PBO | |||||||
**p ≤ 0.0001 vs. PBO | |||||||
FPG (mg/dL) at 12 Weeks | |||||||
Baseline Mean ± SD | Adjusted Mean Change | Difference vs. PBO | |||||
(95% CI) | (95% CI) | ||||||
PBO | 174 ± 40 | 5 | - | ||||
(N = 71) | (−2, 12) | ||||||
EMPA 1 mg | 173 ± 40 | −2 | - | ||||
(N = 71) | (−9, 5) | ||||||
EMPA 5 mg | 180 ± 43 | −16* | - | ||||
−71 | (−23, −9) | ||||||
EMPA 10 mg | 173 ± 36 | −22* | - | ||||
(N = 71) | (−29, −16) | ||||||
EMPA 25 mg | 180 ± 48 | −27* | - | ||||
(N = 70) | (−34, −20) | ||||||
EMPA 50 mg | 175 ± 35 | −28* | - | ||||
(N = 70) | (−35, −21) | ||||||
SITA | 178 ± 44 | −13** | - | ||||
(N = 71) | (−22, −3) | ||||||
*p ≤ 0.0001 vs. PBO | |||||||
**p ≤ 0.01 vs. PBO | |||||||
Body Weight (kg) at 12 Weeks | |||||||
Baseline Mean ± SD | Adjusted Mean Change | Difference vs. PBO | |||||
(95% CI) | (95% CI) | ||||||
PBO | 87.7 ± 15.7 | −1.2 | - |