Strojek (2011) | Randomized Double-blind Parallel-group Placebo- Controlled | 592 T2DM (285M; 307F) | Open-label, Lead in Period: 8 weeks of GLIM daily
Qualification Period: 1 week
Double-blind Placebo-controlled Treatment Period: 24 weeks
Group A: placebo before first meal of day + GLIM
Group B: DAPA 2.5 mg daily before first meal of day + GLIM
Group C: DAPA 5 mg daily before first meal of day + GLIM
Group D: DAPA 10 mg daily before first meal of day + GLIM
Extension Period: 24 weeks | HbA1C (%) at 24 Weeks | |||
Baseline Mean ± SD | Adjusted Mean Change | Difference vs. PBO (95% CI) | |||||
PBO (N = 145) | 8.15 ± 0.74 | −0.13 | - | ||||
DAPA 2.5 mg (N = 154) | 8.11 ± 0.75 | −0.58 | −0.44* | ||||
(−0.61, −0.27) | |||||||
DAPA 5 mg (N = 142) | 8.12 ± 0.78 | −0.63 | −0.49* | ||||
(−0.67, −0.32) | |||||||
DAPA 10 mg (N = 151) | 8.07 ± 0.79 | −0.82 | −0.68* | ||||
(−0.86, −0.51) | |||||||
*p < 0.0001 vs. PBO at α = 0.019 applying Dunnett’s adjustment | |||||||
FPG (mg/dL) at 24 Weeks | |||||||
Baseline Mean ± SD | Adjusted Mean Change | Difference vs. PBO (95% CI) | |||||
PBO (N = 145) | 172.6 ± 37.3 | −2 | - | ||||
DAPA 2.5 mg (N = 154) | 172.3 ± 38.4 | −16.8 | −15 | ||||
(−21.8, −7.9) | |||||||
DAPA 5 mg (N = 142) | 174.4 ± 38.2 | −21.3 | −19.3* | ||||
(−26.3, −12.3) | |||||||
DAPA 10 mg (N = 151) | 172.1 ± 36.8 | −28.5 | −26.5* | ||||
(−33.5, −19.5) | |||||||
*p < 0.0001 vs. PBO | |||||||
Body Weight (kg) at 24 Weeks | |||||||
Baseline Mean | Adjusted Mean Change | Difference vs. PBO (95% CI) | |||||
PBO (N = 145) | 80.94 | −0.72 | - | ||||
DAPA 2.5 mg (N = 154) | 81.89 | −1.18 | −0.46* | ||||
(−1.08, 0.15) | |||||||
DAPA 5 mg (N = 142) | 81 | −1.56 | −0.84** | ||||
(−1.47, −0.21) | |||||||
DAPA 10 mg (N = 151) | 80.56 | −2.26 | −1.54*** | ||||
(−2.17, −0.92) | |||||||
*p = 0.1410 vs. PBO | |||||||
**p = 0.0091 vs. PBO (significant after sequential testing procedure at α = 0.05) | |||||||
***p < 0.0001 vs. PBO (significant after sequential testing procedure at α = 0.05) | |||||||
Bailey (2012) | Randomized Double-blind Parallel- group Placebo- controlled | 282 T2DM (141M; 141F) | Qualification Period: 2 weeks
Single-blind, Placebo Lead-in Period: 2 weeks | HbA1C (%) at 24 Weeks | |||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO (95% CI) | |||||
PBO (N = 68) | 7.8 ± 1.12 | 0.02 | - | ||||
(−0.22, 0.25) | |||||||
DAPA 1 mg (N = 72) | 7.8 ± 0.98 | −0.68 | −0.69* |