MET + PBO (N = 201) | 85.6 ± 20.0 | −1.29 (−1.76 to −0.82) | - | ||||||
DAPA 5 mg + MET (N = 194) | 84.1 ± 19.5 | −2.66 (−3.14, −2.19) | −0.05* (−0.72, 0.61)
−1.37** (−2.04, −0.71) | ||||||
DAPA 5 mg + PBO (N = 203) | 86.2 ± 21.1 | −2.61 (−3.07, −2.15) | - | ||||||
Body Weight (kg) at 24 Weeks - Study II | |||||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. Monotherapy (95% CI) | |||||||
MET + PBO (N = 208) | 87.2 ± 19.4 | −1.36 (−1.83, −0.89) | - | ||||||
DAPA 10 mg + MET (N = 211) | 88.4 ± 19.7 | −3.33 (−3.80, −2.86) | −1.97*** (−2.64, −1.30) | ||||||
DAPA 10 mg + PBO (N = 219) | 88.5 ± 19.3 | −2.73 (−3.19, −2.27) | −1.37**** (−2.03, −0.71) | ||||||
*p = 0.8769 vs. DAPA + PBO | |||||||||
**p < 0.0001 vs. MET + PBO | |||||||||
***p < 0.0001 vs. MET + PBO (after sequential testing procedure at α = 0.05) | |||||||||
****p < 0.0001 vs. DAPA vs. MET (after sequential testing procedure at α = 0.05) | |||||||||
Rosenstock (2012) | Randomized Double-blind Parallel-group Placebo- Controlled | 420 T2DM (208M; 212F) | PIO dose-optimization period for treatment-naïve patients or those receiving MET, SU, or low dose TZD: 10 weeks
Single-blind, Lead-in Period: 2 weeks
Double-blind Treatment Period: 24 weeks
Group A: placebo + PIO 30 mg or 45 mg
Group B: DAPA 5 mg + PIO 30 mg or 45 mg
Group C: DAPA 10 mg + PIO 30 mg or 45 mg
Extension Period: 24 weeks | HbA1C (%) at 24 Weeks | |||||
Baseline Mean ± SD | Adjusted Mean Change ± SE | Difference vs. PBO | |||||||
PBO | 8.34 ± 1.00 | −0.42 ± 0.08 | - | ||||||
(N = 139) | |||||||||
DAPA 5 mg | 8.40 ± 1.03 | −0.82 ± 0.08* | - | ||||||
(N = 141) | |||||||||
DAPA 10 mg | 8.37 ± 0.96 | −0.97 ± 0.08** | - | ||||||
(N = 140) | |||||||||
*p = 0.0007 vs. PBO | |||||||||
**p < 0.0001 vs. PBO | |||||||||
FPG (mg/dL) at 24 Weeks | |||||||||
Baseline Mean ± SD | Adjusted Mean Change ± SE | Difference vs. PBO | |||||||
PBO | 160.7 ± 47.0 | −5.5 ± 2.9 | - | ||||||
(N = 139) | |||||||||
DAPA 5 mg | 168.6 ± 52.1 | −24.9 ± 2.9* | - | ||||||
(N = 141) | |||||||||
DAPA 10 mg | 164.9 ± 46.3 | −29.6 ± 2.9* | - | ||||||
(N = 140) | |||||||||
*p < 0.0001 vs. PBO | |||||||||
Body Weight (kg) at 24 Weeks | |||||||||