Table 1.
Baseline characteristics of the study population by cohort and treatment assignment (N = 3300).
| Baseline characteristics | Cohort 1a |
Cohort 2b |
||
|---|---|---|---|---|
| Placebo (N = 271) | Empagliflozin 10 or 25 mg (N = 552) | Placebo (N = 825) | Empagliflozin 10 or 25 mg (N = 1652) | |
| Age (years) | 60.3 (8.8) | 60.2 (9.1) | 55.7 (10.1) | 55.6 (10.2) |
| Male (%) | 168 (62.0) | 327 (59.2) | 424 (51.4) | 927 (56.1) |
| Race (%) | ||||
| White | 256 (94.5) | 515 (93.3) | 337 (40.8) | 686 (41.5) |
| Asian | 1 (0.4) | 7 (1.3) | 468 (56.7) | 923 (55.9) |
| Other | 14 (5.2) | 30 (5.4) | 20 (2.4) | 43 (2.6) |
| Time since T2DM diagnosis (years) | ||||
| ⩽1 | 7 (2.6) | 21 (3.8) | 112 (13.6) | 273 (16.5) |
| >1–5 | 70 (25.8) | 135 (24.5) | 301 (36.5) | 560 (33.9) |
| >5–10 | 83 (30.6) | 182 (33.0) | 234 (28.4) | 454 (27.5) |
| >10 | 111 (41.0) | 214 (38.8) | 178 (21.6) | 365 (22.1) |
| HbA1c (%) | 7.90 (0.72) | 7.90 (0.74) | 8.02 (0.86) | 7.97 (0.85) |
| Fasting glucose (mg/dL) | 160.1 (35.3) | 159.9 (38.0) | 153.7 (35.9) | 152.6 (34.1) |
| Systolic BP (mmHg) | 142.0 (12.4) | 142.1 (12.3) | 128.6 (14.6) | 129.3 (15.1) |
| Diastolic BP (mmHg) | 83.7 (7.1) | 84.0 (7.0) | 78.0 (8.8) | 78.5 (8.8) |
| Triglycerides (mg/dL) | 170.3 (98.7) | 172.2 (113.4) | 164.5 (111.5) | 173.2 (154.2) |
| HDL cholesterol (mg/dL) | 47.8 (12.9) | 48.7 (12.6) | 48.7 (12.6) | 49.1 (12.6) |
| Weight (kg) | 95.2 (17.5) | 95.2 (18.6) | 78.0 (18.8) | 78.9 (18.8) |
| Body mass index (kg/m2) | 32.4 (4.9) | 32.7 (5.2) | 28.6 (5.5) | 28.7 (5.5) |
| Waist circumference (cm) | 110.1 (13.8) | 110.1 (13.9) | 97.7 (13.9) | 98.0 (13.6) |
| Index of central obesity | 0.65 (0.08) | 0.65 (0.08) | 0.59 (0.08) | 0.59 (0.08) |
| Visceral adiposity index | 2.85 (2.13) | 2.91 (2.79) | 2.73 (2.46) | 2.91 (4.19) |
| Estimated total body fat (%) | 34.8 (9.8) | 35.2 (9.7) | 33.8 (11.1) | 32.9 (11.0) |
T2DM: type 2 diabetes mellitus; HbA1c: glycosylated haemoglobin; BP: blood pressure; HDL: high-density lipoprotein; SD: standard deviation.
Data are mean (SD) or n (%).
a
All randomized and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure value.
b
All randomized and treated patients who had a baseline HbA1c value.