Author (Year) | Study Design | Subjects | Methods | Results | |||
Wilding (2009) | Randomized Double-blind Placebo- controlled | 71 T2DM (42M; 29F) | Stabilization of Insulin Sensitizer Therapy and Insulin: ≥6 weeks with insulin treatment for ≥12 weeks
Double-blind Treatment Period: 12 weeks
Group A: placebo daily + insulin
Group B: DAPA 10 mg daily + insulin
Group C: DAPA 20 mg daily + insulin | HbA1C (%) at 12 Weeks | |||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO (95% CI) | |||||
PBO (N = 23) | 8.4 ± 0.9 | 0.03 | - | ||||
(−0.2, 0.4) | |||||||
DAPA 10 mg (N = 24) | 8.4 ± 0.7 | −0.61 | −0.7 | ||||
(−0.9, −0.4) | (−1.1, −0.3) | ||||||
DAPA 20 mg (N = 24) | 8.5 ± 0.9 | −0.69 | −0.78 | ||||
(−0.9, −0.4) | (−1.2, −0.4) | ||||||
FPG (mg/dL) at 12 Weeks | |||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO (95% CI) | |||||
PBO (N = 23) | 165.9 ± 51.5 | 17.8 | - | ||||
(1.4, 34.2) | |||||||
DAPA 10 mg (N = 24) | 156.0 ± 39.0 | 2.4 | −15.4 | ||||
(−13.6, 18.3) | (−38.4, 7.5) | ||||||
DAPA 20 mg (N = 24) | 161.6 ± 55.0 | −9.6 | −27.4 | ||||
(−25.6, 6.3) |
| ||||||
(−50.3, −4.6) | |||||||
Body Weight (kg) at 12 Weeks | |||||||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO | |||||
(95% CI) | |||||||
PBO (N = 23) | 101.8 ± 16.5 | −1.9 | - | ||||
(−2.9, −0.9) | |||||||
DAPA 10 mg (N = 24) | 103.4 ± 10.2 | −4.5 | −2.6 | ||||
(−5.5, −3.5) | (−4.0, −1.2) | ||||||
DAPA 20 mg (N = 24) | 101.2 ± 15.3 | −4.3 | −2.4 | ||||
(−5.3, −3.3) | (−3.8, −1.0) | ||||||
Bailey (2010) | Randomized Double-blind Parallel Group Placebo- Controlled | 546 T2DM (292M; 254F) | Single-blind, Placebo Lead-in Period : 2 weeks
Double-blind Treatment Period: 24 weeks (All groups on stable MET dose)
Group A: placebo + MET daily in AM
Group B: DAPA 2.5 mg + MET daily in AM
Group C: DAPA 5 mg + MET daily in AM | HbA1C (%) at 24 Weeks | |||
Baseline Mean ± SD | Adjusted Mean Change (95% CI) | Difference vs. PBO (95% CI) | |||||
PBO (N = 137) | 8.11 ± 0.96 | −0.3 | - | ||||
(−0.44, −0.16) | |||||||
DAPA 2.5 mg (N = 137) | 7.99 ± 0.90 | −0.67*† | - | ||||
(−0.81, −0.53) | |||||||
DAPA 5 mg (N = 137) | 8.17 ± 0.96 | −0.70**† | - | ||||
(−0.85, −0.56) | |||||||
DAPA 10 mg (N = 135) | 7.92 ± 0.82 | −0.84**† | - | ||||
(−0.98, −0.70) | |||||||
*p = 0.0002 | |||||||
**p < 0.0001 |