Placebo + metformin (n = 137) | Dapagliflozin 2.5 mg + metformin (n = 137) | Dapagliflozin 5 mg + metformin (n = 137) | Dapagliflozin 10 mg + metformin(n = 135) | |
---|---|---|---|---|
Sodium (mmol/l) | ||||
N | 72 | 77 | 87 | 93 |
Baseline | 138.9 (2.3) | 138.5 (2.9) | 138.6 (2.3) | 139.1 (2.2) |
Change at week 102 | -0.04 [2.7] | 0.2 [2.8] | 0.1 [2.6] | 0.1 [2.6] |
P vs PBO + MET | 0.1434 | 0.1905 | 0.3978 | |
Potassium (mmol/l) | ||||
n | 72 | 77 | 87 | 93 |
Baseline | 4.35 (0.47) | 4.34 (0.46) | 4.37 (0.39) | 4.37 (0.43) |
Change at week 102 | -0.08 [0.55] | -0.01 [0.45] | -0.05 [0.35] | -0.07 [0.47] |
P vs PBO + MET | 0.3366 | 0.4563 | 0.9918 | |
Serum creatinine (μmol/l) | ||||
n | 72 | 77 | 88 | 93 |
Baseline | 76.9 (17.9) | 78.7 (18.1) | 79.6 (19.3) | 77.8 (17.8) |
Change at week 102 | -0.9 [10.3] | -1.8 [9.7] | -3.5 [12.7] | -2.7 [10.6] |
P vs PBO + MET | 0.9954 | 0.4720 | 0.9032 | |
Serum uric acid (μmol/l) a | ||||
n | 28 | 35 | 47 | 57 |
Baseline | 314 (79) | 322 (80) | 323 (88) | 323 (80) |
Change at week 102 | -1.78 [54.13] | -55.9 [50.32] | -46.4 [64.36] | -52.9 [64.36] |
P vs PBO + MET | 0.0054 | 0.0013 | 0.0002 | |
Blood urea nitrogen (mmol/l) | ||||
n | 72 | 77 | 88 | 93 |
Baseline | 5.33 (1.55) | 5.51 (1.41) | 5.65 (1.81) | 5.34 (1.41) |
Change at week 102 | 0.56 [1.24] | 0.70 [1.54] | 0.42 [1.87] | 0.73 [1.44] |
P vs PBO + MET | 0.2299 | 0.4169 | 0.0845 | |
Hematocrit (%) | ||||
n | 71 | 78 | 87 | 93 |
Baseline | 42.61 (3.90) | 42.38 (3.99) | 42.15 (3.59) | 42.88 (3.95) |
Change at week 102 | -1.43 [3.29] | 0.84 [2.53] | 1.35 [2.48] | 1.54 [2.78] |
P vs PBO + MET | <0.0001 | <0.0001 | <0.0001 | |
Hemoglobin (g/l) | ||||
n | 71 | 78 | 87 | 94 |
Baseline | 142.8 (13.45) | 142.5 (14.25) | 141.6 (12.19) | 143.6 (13.10) |
Change at week 102 | -4.9 [10.14] | 1.5 [7.73] | 3.1 [8.40] | 4.1 [8.84] |
P vs PBO + MET | <0.0001 | <0.0001 | <0.0001 | |
Systolic blood pressure (mmHg) | ||||
n | 72 | 78 | 88 | 94 |
Baseline | 128 (15) | 127 (14) | 127 (14) | 126 (16) |
Change at week 102 | 1.5 [13.7] | 0.7 [16.1] | -1.1 [13.2] | -0.3 [15.0] |
P vs PBO + MET | 0.1111 | 0.0136 | 0.0067 | |
Diastolic blood pressure (mmHg) | ||||
n | 72 | 78 | 88 | 94 |
Baseline | 81 (9) | 80 (9) | 81 (9) | 79 (10) |
Change at week 102 | -1.0 [7.9] | -0.1 [8.1] | -1.5 [8.1] | -1.2 [10.1] |
P vs PBO + MET | 0.6605 | 0.2140 | 0.1075 |