Double-blind Treatment Period: 24 weeks
Group A: placebo daily with morning meal
Group B: DAPA 1 mg daily with morning meal
Group C: DAPA 2.5 mg daily with morning meal
Group D: DAPA 5 mg daily with morning meal
Safety-assessment Follow-up Period: 4 weeks | (−0.91, −0.45) | (−1.02, −0.37) | ||||||
DAPA 2.5 mg (N = 74) | 8.1 ± 1.07 | −0.72 | −0.74* | |||||
(−0.95, −0.49) | (−1.07, −0.41) | |||||||
DAPA 5 mg (N = 68) | 7.9 ± 1.03 | −0.82 | −0.84* | |||||
(−1.06, −0.58) | (−1.17, −0.50) | |||||||
*p < 0.0001 vs. PBO | ||||||||
FPG (mg/dL) at 24 Weeks | ||||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO (95% CI) | ||||||
PBO (N = 68) | 161.6 ± 57.5 | 4.1 | - | |||||
(−4.1, 12.4) | ||||||||
DAPA 1 mg (N = 72) | 155.5 ± 48.3 | −11 | −15.1* | |||||
(−19.1, −3.1) | (−26.7, −3.6) | |||||||
DAPA 2.5 mg (N = 74) | 159.8 ± 51.5 | −21.6 | −25.8** | |||||
(−29.5, −13.7) | (−37.1, −14.2) | |||||||
DAPA 5 mg (N = 68) | 157.1 ± 41.6 | −28.5 | −32.6** | |||||
(−36.8, −20.2) | (−44.3, −20.7) | |||||||
*p = 0.0103 vs. PBO | ||||||||
**p < 0.0001 vs. PBO | ||||||||
Body Weight (kg) at 24 Weeks | ||||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO (95% CI) | ||||||
PBO (N = 68) | 90.0 ± 17.98 | −0.96 | - | |||||
(−1.74, −0.19) | ||||||||
DAPA 1 mg (N = 72) | 88.2 ± 18.49 | −2.69 | −1.73* | |||||
(−3.44, −1.94) | (−2.81, −0.65) | |||||||
DAPA 2.5 mg (N = 74) | 84.3 ± 18.18 | −2.64 | −1.68** | |||||
(−3.38, −1.90) | (−2.76, −0.60) | |||||||
DAPA 5 mg (N = 68) | 85.4 ± 19.43 | −2.69 | −1.73*** | |||||
(−3.47, −1.91) | (−2.83, −0.63) | |||||||
*p = 0.0018 vs. PBO | ||||||||
**p = 0.0024 vs. PBO | ||||||||
***p = 0.0022 vs. PBO | ||||||||
Henry (2012) | Two Randomized Double-blind Active- controlled | 1236 T2DM (573M; 663F) | Single-blind Placebo Lead-in Period: 1 week
Double-blind Treatment Period: 24 weeks
Study I: Group A: MET XR + placebo combination with evening meal | HbA1C (%) at 24 Weeks - Study I | ||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. Monotherapy (95% CI) | ||||||
MET + PBO (N = 201) | 9.2 ± 1.3 | −1.35 (−1.53, −1.18) | - | |||||
DAPA 5 mg + MET (N = 194) | 9.2 ± 1.3 | −2.05 (−2.23, −1.88) | −0.86* (−1.11, −0.62)
−0.70** (−0.94, −0.45) | |||||