Double-blind Placebo-controlled Treatment Period: 24 weeks (with open-label insulin/existing OAD therapies)
Group A: placebo + insulin
Group B: DAPA 2.5 mg daily + insulin
Group C: DAPA 5 mg daily + insulin
Group D: DAPA 10 mg daily + insulin
Double-blind Extension Period I: 24 weeks
Double-blind Extension Period II: 56 weeks | DAPA 5 mg | 8.62 ± 0.89 | −0.89 | −0.49* | |||
(N = 211) | (−0.65, −0.34) | ||||||
DAPA 10 mg | 8.57 ± 0.82 | −0.96 | −0.57* | ||||
(N = 194) | (−0.72, −0.42) | ||||||
*p < 0.001 vs. PBO | |||||||
FPG (mg/dL) at 24 Weeks | |||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO | |||||
PBO | 170.6 ± 57.2 | - | - | ||||
(N = 193) | |||||||
DAPA 2.5 mg | 180.1 ± 59.9 | −11.71* | - | ||||
(N = 202) | (−21.4, −2.0) | ||||||
DAPA 5 mg | 185.4 ± 58.7 | −20.18* | - | ||||
(N = 211) | (−29.9, −10.6) | ||||||
DAPA 10 mg | 173.1 ± 54.9 | −19.82* | - | ||||
(N = 194) | (−29.6, −10.1) | ||||||
*p < 0.001 vs. baseline | |||||||
Body Weight (kg) at 24 Weeks | |||||||
Baseline Mean ± SD | Adjusted Mean Change | Difference vs. PBO (95% CI) | |||||
PBO | 94.5 ± 19.8 | 0.43 | - | ||||
(N = 193) | |||||||
DAPA 2.5 mg | 93.0 ± 16.7 | −0.92 | −1.35* | ||||
(N = 202) | (−1.90, −0.80) | ||||||
DAPA 5 mg | 93.3 ± 17.4 | −1 | −1.42* | ||||
(N = 211) | (−1.97, −0.88) | ||||||
DAPA 10 mg | 94.5 ± 16.8 | −1.61 | −2.04* | ||||
(N = 194) | (−2.59, −1.48) | ||||||
*p < 0.001 vs. PBO | |||||||
HbA1C (%) at 48 Weeks | |||||||
Baseline Mean ± SD | Adjusted Mean Change | Difference vs. PBO (95% CI) | |||||
PBO | 8.47 ± 0.77 | −0.47 | - | ||||
(N = 193) | |||||||
DAPA 2.5 mg | 8.46 ± 0.78 | −0.79 | −0.32* | ||||
(N = 202) | (−0.48, −0.16) | ||||||
DAPA 5 mg | 8.62 ± 0.89 | −0.96 | −0.49* | ||||
(N = 211) | (−0.65, −0.33) | ||||||
DAPA 10 mg | 8.57 ± 0.82 | −1.01 | −0.54* | ||||
(N = 194) | (−0.70, −0.38) | ||||||
*p < 0.001 vs. PBO | |||||||
FPG (mg/dL) at 48 Weeks |