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) | |
| P vs 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) | |
| P vs 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) | |
| P vs 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) | |
| P vs PBO + MET | 0.2380 | 0.0176 | 0.0011 |
n indicates the number of randomized patients who took at least one dose of double-blind study medication. Data are means (SD) or means (95% CI). aAdjusted mean change from baseline using longitudinal repeated measures, excluding data after rescue, except weight, which includes data after rescue. bPercentage adjusted for baseline glycated hemoglobin (HbA1c). Patients discontinued or rescued prior to week t (t = 24 or 102) or missed measurements at week t are considered not achieving glycemic response. DAPA = dapagliflozin; FPG = fasting plasma glucose; MET = metformin; PBO = placebo.