| Group B: DAPA 2.5 mg daily in AM
Group C: DAPA 5 mg daily in AM
Group D: DAPA 10 mg daily in AM
(Exploratory cohort assessments not included) | Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO | ||||
| PBO (N = 75) | 159.9 ± 42.1 | −4.1 | - | ||||
| (−11.8, 3.5) | |||||||
| DAPA 2.5 mg (N = 65) | 164.1 ± 48.0 | −15.2 | - | ||||
| (−23.5, −7.0) | |||||||
| DAPA 5 mg (N = 64) | 162.2 ± 45.0 | −24.1* | - | ||||
| (−32.5, −15.6) | |||||||
| DAPA 10 mg (N = 70) | 166.6 ± 41.5 | −28.8** | - | ||||
| (−36.8, −20.9) | |||||||
| *p < 0.001 | |||||||
| **p < 0.0001 (α = 0.019 [two-sided] applyinh Dunnett adjustment) | |||||||
| Body Weight (kg) at 24 Weeks | |||||||
| Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO | |||||
| PBO (N = 75) | 88.8 ± 19.0 | −2.2 | - | ||||
| (−3.3, −1.3) | |||||||
| DAPA 2.5 mg (N = 65) | 90.8 ± 22.8 | −3.3 | - | ||||
| (−4.2, −2.3) | |||||||
| DAPA 5 mg (N = 64) | 87.6 ± 17.1 | −2.8 | - | ||||
| (−3.8, −1.9) | |||||||
| DAPA 10 mg (N = 70) | 94.2 ± 18.7 | −3.2 | - | ||||
| (−4.0, −2.3) | |||||||
| Nauck (2011) | Randomized Double-blind Parallel-group Active- controlled Noninferiority | 801 T2DM (441M; 360F) | MET Stabilization Period: 8 weeks
Single-blind, Placebo Lead-in Period: 2 weeks
Double-blind Treatment Period: 52 weeks (18-week titration period with 3 week intervals and 34-week maintenance period)
Group A: DAPA 2.5 mg, titrated to 5 or 10 mg if FPG ≥ 6.1 mmol/L + metformin
Group B GLIP 5 mg, titrated to 10 or 20 mg if FPG ≥ 6.1 mmol/L + metformin
Extension Period: 156 weeks | HbA1C (%) at 52 Weeks | |||
| Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. GLIP (95% CI) | |||||
| GLIP (N = 401) | 7.7 ± 0.9 | −0.52 | - | ||||
| (−0.60, 0.44) | |||||||
| DAPA (N = 400) | 7.7 ± 0.9 | −0.52 | 0 | ||||
| (−0.60, 0.44) | (−0.11, 0.11) | ||||||
| FPG (mg/dL) at 52 Weeks | |||||||
| Baseline Mean | Adjusted Mean Change (95% CI) | Difference vs. GLIP (95% CI) | |||||
| GLIP (N = 401) | 164.0 ± 41.4 | −18.7 | - | ||||
| (−22.0, −17.7) | |||||||
| DAPA (N = 400) | 162.2 ± 37.8 | −22.3 | −3.6 | ||||
| (−25.6, −19.3) | (−7.9, 0.9) | ||||||
| Body Weight (kg) at 52 Weeks | |||||||
| Baseline Mean | Adjusted Mean Change (95% CI) | Difference vs. GLIP (95% CI) | |||||
| GLIP (N = 401) | 87.6 | 1.44 | - | ||||
| (1.09, 1.78) | |||||||
| DAPA (N = 400) | 88.4 | −3.22 | −4.65* | ||||
| (−3.56, −2.87) | (−5.14, −4.17) | ||||||
| *p < 0.0001 vs. GLIP | |||||||