Table 1.
Baseline demographics and clinical characteristics (ITT population)
| Exenatide QW plus dapagliflozin (n = 228) | Exenatide QW plus placebo (n = 227) | Dapagliflozin plus placebo (n = 230) | |
|---|---|---|---|
| Age, mean (SD), years | 53.8 (9.82) | 54.2 (9.62) | 54.5 (9.16) |
| Male, n (%) | 102 (44.7) | 116 (51.1) | 110 (47.8) |
| Race, n (%) | |||
| White | 190 (83.3) | 194 (85.5) | 189 (82.2) |
| Black | 34 (14.9) | 27 (11.9) | 33 (14.3) |
| Asian | 3 (1.3) | 1 (0.4) | 1 (0.4) |
| Other | 1 (0.4) | 5 (2.2) | 7 (3.0) |
| Hispanic or Latino ethnicity, n (%) | 95 (41.7) | 91 (40.1) | 85 (37.0) |
| Weight, mean (SD), kg | 91.8 (22.2) | 89.8 (20.2) | 91.1 (19.7) |
| BMI, mean (SD), kg/m2 | 33.2 (6.8) | 32.0 (5.9) | 33.0 (6.1) |
| BMI group, n (%), kg/m2 | |||
| <25 | 17 (7.5) | 17 (7.5) | 15 (6.5) |
| ≥25 to <30 | 71 (31.1) | 78 (34.4) | 57 (24.8) |
| ≥30 | 140 (61.4) | 132 (58.1) | 158 (68.7) |
| HbA1c, mean (SD), % | 9.3 (1.1) | 9.30 (1.1) | 9.3 (1.0) |
| HbA1c, mean (SD), mmol/mol | 79 (11.7) | 78 (11.6) | 78 (11.3) |
| HbA1c group, n (%) | |||
| <8.0% (<64 mmol/mol) | 14 (6.1) | 13 (5.7) | 14 (6.1) |
| ≥8.0% to <9.0% (≥64 to <75 mmol/mol) | 84 (36.8) | 84 (37.0) | 88 (38.3) |
| ≥9.0% (≥75 mmol/mol) | 130 (57.0) | 130 (57.3) | 128 (55.7) |
| Duration of type 2 diabetes, mean (SD), years | 7.6 (6.0) | 7.4 (5.5) | 7.1 (5.5) |
| FPG, mean (SD), mmol/L | 11.0 (3.0) | 10.7 (2.8) | 10.6 (2.6) |
| SBP, mean (SD), mmHg | 130.1 (12.7) | 129.1 (13.1) | 130.0 (12.9) |
| eGFR-MDRD, mean (SD), mL/min/1.73 m2 | 97.7 (23.7) | 99.4 (26.8) | 97.5 (24.0) |
| eGFR-MDRD group, n (%) | |||
| ≥30 to <60 mL/min/1.73 m2 | 6 (2.6) | 7 (3.1) | 12 (5.2) |
| ≥60 mL/min/1.73 m2 | 222 (97.4) | 220 (96.9) | 218 (94.8) |