Demographics and baseline characteristics at randomization
| . | Placebo add-on to saxagliptin plus metformin (n = 160) . | Dapagliflozin add-on to saxagliptin plus metformin (n = 160) . | Total (n = 320) . |
|---|---|---|---|
| Age, years | 55.0 ± 9.6 | 55.2 ± 8.6 | 55.1 ± 9.1 |
| Women | 84 (52.5) | 90 (56.3) | 174 (54.4) |
| Race | |||
| White | 147 (91.9) | 150 (93.8) | 297 (92.8) |
| African American | 10 (6.3) | 8 (5.0) | 18 (5.6) |
| Asian | 1 (0.6) | 1 (0.6) | 2 (0.6) |
| Other | 2 (1.3) | 1 (0.6) | 3 (0.9) |
| BMI, kg/m2 | 32.2 ± 5.3 | 31.2 ± 4.7 | 31.7 ± 5.1 |
| Duration of diabetes, years | 8.0 ± 6.6 | 7.2 ± 5.7 | 7.6 ± 6.1 |
| HbA1c | |||
| % | 8.17 ± 0.98 | 8.24 ± 0.96 | 8.20 ± 0.97 |
| mmol/mol | 66 ± 10.7 | 67 ± 10.5 | 66 ± 10.6 |
| HbA1c category | |||
| <8% (64 mmol/mol) | 75 (46.9) | 69 (43.1) | 144 (45.0) |
| ≥8% and <9% (≥64 and <75 mmol/mol) | 53 (33.1) | 51 (31.9) | 104 (32.5) |
| ≥9% (75 mmol/mol) | 32 (20.0) | 40 (25.0) | 72 (22.5) |
| FPG, mg/dL | 177 ± 46.8 | 179 ± 48.9 | 178 ± 47.8 |
| 2-h PPG, mg/dL | 243 ± 57.5 (n = 154) | 242 ± 60.9 (n = 156) | 242 ± 59.1 (n = 310) |
| Fasting C-peptide, ng/mL | 2.6 ± 1.1 | 2.5 ± 1.1 | 2.6 ± 1.1 |
| eGFR, mL/min/1.73 m2 | 91.6 ± 23.2 | 93.5 ± 20.8 | 92.5 ± 22.0 |
| Randomization stratification | |||
| Stratum A | 109 (68.1) | 110 (68.8) | 219 (68.4) |
| Stratum B | 51 (31.9) | 50 (31.3) | 101 (31.6) |
| . | Placebo add-on to saxagliptin plus metformin (n = 160) . | Dapagliflozin add-on to saxagliptin plus metformin (n = 160) . | Total (n = 320) . |
|---|---|---|---|
| Age, years | 55.0 ± 9.6 | 55.2 ± 8.6 | 55.1 ± 9.1 |
| Women | 84 (52.5) | 90 (56.3) | 174 (54.4) |
| Race | |||
| White | 147 (91.9) | 150 (93.8) | 297 (92.8) |
| African American | 10 (6.3) | 8 (5.0) | 18 (5.6) |
| Asian | 1 (0.6) | 1 (0.6) | 2 (0.6) |
| Other | 2 (1.3) | 1 (0.6) | 3 (0.9) |
| BMI, kg/m2 | 32.2 ± 5.3 | 31.2 ± 4.7 | 31.7 ± 5.1 |
| Duration of diabetes, years | 8.0 ± 6.6 | 7.2 ± 5.7 | 7.6 ± 6.1 |
| HbA1c | |||
| % | 8.17 ± 0.98 | 8.24 ± 0.96 | 8.20 ± 0.97 |
| mmol/mol | 66 ± 10.7 | 67 ± 10.5 | 66 ± 10.6 |
| HbA1c category | |||
| <8% (64 mmol/mol) | 75 (46.9) | 69 (43.1) | 144 (45.0) |
| ≥8% and <9% (≥64 and <75 mmol/mol) | 53 (33.1) | 51 (31.9) | 104 (32.5) |
| ≥9% (75 mmol/mol) | 32 (20.0) | 40 (25.0) | 72 (22.5) |
| FPG, mg/dL | 177 ± 46.8 | 179 ± 48.9 | 178 ± 47.8 |
| 2-h PPG, mg/dL | 243 ± 57.5 (n = 154) | 242 ± 60.9 (n = 156) | 242 ± 59.1 (n = 310) |
| Fasting C-peptide, ng/mL | 2.6 ± 1.1 | 2.5 ± 1.1 | 2.6 ± 1.1 |
| eGFR, mL/min/1.73 m2 | 91.6 ± 23.2 | 93.5 ± 20.8 | 92.5 ± 22.0 |
| Randomization stratification | |||
| Stratum A | 109 (68.1) | 110 (68.8) | 219 (68.4) |
| Stratum B | 51 (31.9) | 50 (31.3) | 101 (31.6) |
Data are mean ± SD or n (%), unless otherwise indicated. eGFR, estimated glomerular filtration rate calculated by MDRD formula.