Table 1 Change from baseline in efficacy parameters
Placebo + metformin (n = 137) | Dapagliflozin 2.5 mg + metformin (n = 137) | Dapagliflozin 5 mg + metformin (n = 137) | Dapagliflozin 10 mg + metformin (n = 135) | |
|---|---|---|---|---|
HbA1c (%):a | ||||
Baseline (SD) | 8.12 (0.96) | 7.99 (0.90) | 8.17 (0.96) | 7.92 (0.82) |
Change at week 24 (95% CI) | -0.31 (-0.45 to -0.16) | -0.65 (-0.79 to -0.51) | -0.67 (-0.81 to -0.53) | -0.82 (-0.96 to -0.68) |
Difference vs PBO (95% CI) | -0.35 (-0.55 to -0.14) | -0.36 (-0.56, -0.16) | -0.51 (-0.71, -0.31) | |
Change at week 102 (95% CI) | 0.02 (-0.20 to 0.23) | -0.48 (-0.68 to -0.29) | -0.58 (-0.77 to -0.39) | -0.78 (-0.97 to -0.60) |
Difference vs PBO (95% CI) | -0.50 (-079 to -0.21) | -0.60 (-0.89 to -0.31) | -0.80 (-1.08 to -0.52) | |
Pvs PBO + MET | 0.0008 | <0.0001 | <0.0001 | |
FPG (mmol/l): a | ||||
Baseline (SD) | 9.19 (2.58) | 8.96 (2.39) | 9.39 (2.72) | 8.66 (2.15) |
Change at week 24 (95% CI) | -0.29 (-0.59 to 0.01) | -0.95 (-1.23 to -0.67) | -1.15 (-1.44 to -0.88) | -1.23 (-1.51 to -0.94) |
Difference vs PBO (95% CI) | -0.66 (-1.07 to -0.25) | -0.87 (-1.28 to -0.46) | -0.94 (-1.35 to -0.53) | |
Change at week 102 (95% CI) | -0.58 (-0.97 to -0.19) | -1.07 (-1.42 to -0.72) | -1.47 (-1.78 to -1.16) | -1.36 (-1.65, -1.07) |
Difference vs PBO (95% CI) | -0.49 (-0.99 to 0.01) | -0.89 (-1.37 to -0.41) | -0.78 (-1.25 to -0.31) | |
Pvs PBO + MET | 0.0518 | 0.0003 | 0.0012 | |
Weight (kg): a | ||||
Baseline (SD) | 87.74 (19.24) | 84.90 (17.77) | 84.73 (16.26) | 86.28 (17.53) |
Change at week 24 (95% CI) | -0.40 (-0.91 to 0.11) | -1.96 (-2.47 to -1.44) | -2.92 (-3.43 to -2.41) | -2.65 (-3.16 to -2.13) |
Difference vs PBO (95% CI) | -1.55 (-2.27 to -0.84) | -2.52 (-3.23 to -1.80) | -2.24 (-2.96 to -1.53) | |
Change at week 102 (95% CI) | 1.36 (0.53 to 2.20) | -1.10 (-1.91 to -0.29) | -1.70 (-2.48 to -0.91) | -1.74 (-2.51 to -0.96) |
Difference vs PBO (95% CI) | -2.46 (-3.63 to -1.30) | -3.06 (-4.21 to -1.92) | -3.10 (-4.24 to -1.96) | |
Pvs PBO + MET | <0.0001 | <0.0001 | <0.0001 | |
Percentage of patients with HbA1c <7.0% (95% CI): b | ||||
At week 24 | 24.2 (17.4 to 30.9) | 30.9 (23.4 to 38.4) | 35.9 (28.4 to 43.5) | 38.2 (30.3 to 46.1) |
Difference vs PBO (95% CI) | 6.7 (-3.2 to 16.6) | 11.8 (1.9 to 21.6) | 14.0 (3.9 to 24.1) | |
At week 102 | 15.4 (9.5 to 21.3) | 20.7 (14.0 to 27.3) | 26.4 (19.4 to 33.4) | 31.5 (23.7 to 39.3) |
Difference vs PBO (95% CI) | 5.3 (-3.5 to 14.1) | 11.0 (1.9 to 20.0) | 16.1 (6.4 to 25.7) | |
Pvs PBO + MET | 0.2380 | 0.0176 | 0.0011 |