(N = 137) | (−25.6, −13.0) | (−17.8, 0.2) | |||||
DAPA 5 mg | 169.2 ± 49.0 | −26.5 | −16.0** | ||||
(N = 137) | (−32.1, −20.9) | (−24.7, −7.4) | |||||
DAPA 10 mg | 156.0 ± 38.7 | −24.5 | −14.1*** | ||||
(N = 135) | (−29.7, −19.3) | (−22.5, −5.6) | |||||
*p = 0.0518 vs. PBO | |||||||
**p = 0.0003 vs. PBO | |||||||
***p = 0.0012 vs. PBO | |||||||
Body Weight (kg) at 102 Weeks | |||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO (95% CI) | |||||
PBO | 87.74 ± 19.24 | 1.36 | - | ||||
(N = 137) | (0.53, 2.20) | ||||||
DAPA 2.5 mg | 84.90 ± 17.77 | −1.1 | −2.46* | ||||
(N = 137) | (−1.91, −0.29) | (−3.63, −1.30) | |||||
DAPA 5 mg | 84.73 ± 16.26 | −1.7 | −3.06* | ||||
(N = 137) | (−2.48, −0.91) | (−4.21, −1.92) | |||||
DAPA 10 mg | 86.28 ± 17.53 | −1.74 | −3.10* | ||||
(N = 135) | (−2.51, −0.96) | (−4.24, −1.96) | |||||
*p < 0.0001 vs. PBO | |||||||
Kaku (2013) | Randomized Double-blind Parallel-group Placebo- controlled | 279 T2DM (215M; 64F) | Washout Period: 6 weeks if on prior OAD
Single-blind Placebo Lead-in Period: 4 weeks
Double-blind Treatment Period: 12 weeks
Group A: placebo daily
Group B: DAPA 1 mg daily
Group C: DAPA 2.5 mg daily
Group D: DAPA 5 mg daily
Group E: DAPA 10 mg daily
Follow-up Period: 4 weeks | HbA1C (%) at 12 Weeks | |||
Baseline Mean ± SD | Adjusted Mean Change ± SE | Difference vs. PBO (95% CI) | |||||
PBO | 8.12 ± 0.71 | 0.37 ± 0.07 | - | ||||
(N = 54) | |||||||
DAPA 1 mg | 8.10 ± 0.79 | −0.12 ± 0.07 | −0.49* | ||||
(N = 59) | (−0.68, −0.29) | ||||||
DAPA 2.5 mg | 7.92 ± 0.74 | −0.11 ± 0.07 | −0.48* | ||||
(N = 56) | (−0.67, −0.28) | ||||||
DAPA 5 mg | 8.05 ± 0.66 | −0.37 ± 0.07 | −0.74* | ||||
(N = 58) | (−0.93, −0.54) | ||||||
DAPA 10 mg | 8.18 ± 0.69 | −0.44 ± 0.07 | −0.80* | ||||
(N = 52) | (−1.00, −0.61) | ||||||
*p < 0.0001 vs. PBO (tested at α = 0.015 applying Dunnett adjustment | |||||||
FPG (mg/dL) at 12 Weeks | |||||||
Baseline Mean ± SD | Adjusted Mean Change ± SE | Difference vs. PBO | |||||
PBO | 158.94 ± 31.08 | 11.17 ± 3.43 | - | ||||
(N = 54) | |||||||
DAPA 1 mg | 163.53 ± 33.06 | −15.61 ± 3.43* | - | ||||
(N = 59) | |||||||
DAPA 2.5 mg | 159.17 ± 31.98 | −19.83 ± 3.37* | - | ||||
(N = 56) |