Baseline Mean ± SD | Adjusted Mean Change ± SE | Difference vs. PBO | ||||||
PBO | 86.4 ± 21.3 | 1.64 ± 0.28 | - | |||||
(N = 139) | ||||||||
DAPA 5 mg | 87.8 ± 20.7 | 0.09 ± 0.28* | - | |||||
(N = 141) | ||||||||
DAPA 10 mg | 84.8 ± 22.2 | −0.14 ± 0.28* | - | |||||
(N = 140) | ||||||||
*p < 0.0001 vs. PBO | ||||||||
HbA1C (%) at 48 Weeks | ||||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO | ||||||
PBO | 8.34 ± 1.00 | −0.54 | - | |||||
(N = 139) | (−0.70, −0.38) | |||||||
DAPA 5 mg | 8.40 ± 1.03 | −0.95 | - | |||||
(N = 141) | (−1.10, −0.80) | |||||||
DAPA 10 mg | 8.37 ± 0.96 | −1.21 | - | |||||
(N = 140) | (−1.36, −1.06) | |||||||
FPG (mg/dL) at 48 Weeks | ||||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO | ||||||
PBO | 160.7 ± 47.0 | −13.1 | - | |||||
(N = 139) | (−20.2, −6.0) | |||||||
DAPA 5 mg | 168.6 ± 52.1 | −22.8 | - | |||||
(N = 141) | (−29.1 to −16.4) | |||||||
DAPA 10 mg | 164.9 ± 46.3 | −33.1 | - | |||||
(N = 140) | (−39.0, −27.2) | |||||||
Body Weight (kg) at 48 Weeks | ||||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO | ||||||
PBO | 86.4 ± 21.3 | 2.99 | - | |||||
(N = 139) | (2.19, 3.79) | |||||||
DAPA 5 mg | 87.8 ± 20.7 | 1.35 | - | |||||
(N = 141) | (0.61, 2.09) | |||||||
DAPA 10 mg | 84.8 ± 22.2 | 0.69 | - | |||||
(N = 140) | (−0.03, 1.41) | |||||||
Wilding (2012) | Randomized Double-blind Parallel-group Placebo- controlled | 800 T2DM (382M; 418F) | Pre-enrollment OAD/ Insulin Stabilization Period: at least 8 weeks
Enrollment Period: 2 weeks | HbA1C (%) at 24 Weeks | ||||
Baseline Mean ± SD | Adjusted Mean Change | Difference vs. PBO (95% CI) | ||||||
PBO | 8.47 ± 0.77 | −0.39 | - | |||||
(N = 193) | ||||||||
DAPA 2.5 mg | 8.46 ± 0.78 | −0.79 | −0.40* | |||||
(N = 202) | (−0.54, −0.25) | |||||||