Group B: DAPA 5 mg + MET XR combination with evening meal
Group C: DAPA 5 mg + placebo combination with evening meal
Study II: Group A: MET XR + placebo combination with evening meal
Group B: DAPA 10 mg + MET XR combination with evening meal
Group C: DAPA 10 mg + placebo combination with evening meal | DAPA 5 mg + PBO (N = 203) | 9.1 ± 1.4 | −1.19 (−1.36, −1.02) | - | ||||
HbA1C (%) at 24 Weeks - Study II | ||||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. Monotherapy (95% CI) | ||||||
MET + PBO | 9.1 ± 1.3 | −1.44 | - | |||||
(N = 208) | (−1.59, −1.29) | |||||||
DAPA 10 mg + MET (N = 211) | 9.1 ± 1.3 | −1.98 (−2.13, −1.83) | −0.53* (−0.74, −0.32)
−0.54** (−0.75, −0.33) | |||||
DAPA 10 mg + PBO (N = 219) | 9.1 ± 1.3 | −1.45 (−1.59, −1.31) | - | |||||
*p < 0.0001 vs. DAPA + PBO | ||||||||
**p < 0.0001 vs. MET + PBO | ||||||||
FPG (mg/dL) at 24 Weeks - Study I | ||||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. Monotherapy (95% CI) | ||||||
MET + PBO | 197.1 ± 60.4 | −33.5 | - | |||||
(N = 201) | (−38.9, −28.3) | |||||||
DAPA 5 mg + MET (N = 194) | 193.9 ± 56.2 | −61.1 (−66.5, −55.7) | −19.1* (−26.7, −11.4)
−27.6** (−35.1, −19.8) | |||||
DAPA 5 mg + PBO (N = 203) | 190.8 ± 56.6 | −42 (−47.4, −36.8) | - | |||||
FPG (mg/dL) at 24 Weeks - Study II | ||||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. Monotherapy (95% CI) | ||||||
MET + PBO (N = 208) | 190.5 ± 54.1 | −34.8 (−39.8, −29.7) | - | |||||
DAPA 10 mg + MET (N = 211) | 189.5 ± 58.0 | −60.4 (−65.2, −55.3) | −13.9* (−20.9, −7.0)
−25.6** (−32.6, −18.6) | |||||
DAPA 10 mg + PBO (N = 219) | 198.0 ± 61.8 | −46.5 (−51.4, −41.4) | - | |||||
*p < 0.0001 vs. DAPA + PBO (after sequential testing procedure at α = 0.05) | ||||||||
**p < 0.0001 vs. MET + PBO (after sequential testing procedure at α = 0.05) | ||||||||
Body Weight (kg) at 24 Weeks - Study I | ||||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. Monotherapy (95% CI) | ||||||