Table 1.
Patient demographics and baseline characteristics (full analysis set)
| Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | |
|---|---|---|---|
| N | 21 | 20 | 19 |
| Male | 17 (81.0) | 14 (70.0) | 16 (84.2) |
| Age (years) | 60.7 (10.8) | 64.8 (5.9) | 62.6 (7.8) |
| Time since diagnosis of type 2 diabetes | |||
| ≤5 years | 9 (42.9) | 4 (20.0) | 5 (26.3) |
| >5 to 10 years | 9 (42.9) | 8 (40.0) | 7 (36.8) |
| >10 years | 3 (14.3) | 8 (40.0) | 7 (36.8) |
| Number of anti-diabetes medications | |||
| 0 | 18 (85.7) | 16 (80.0) | 17 (89.5) |
| 1 | 3 (14.3) | 4 (20.0) | 2 (10.5) |
| Body weight (kg) | 67.7 (10.0) | 63.5 (10.6) | 65.9 (12.1) |
| Body mass index (kg/m2) | 24.9 (2.8) | 24.1 (3.7) | 24.0 (3.2) |
| HbA1c (%) | 8.00 (0.82) | 7.99 (0.83) | 7.73 (0.75) |
| Fasting plasma glucose (mg/dl)* | 154.5 (19.8) | 151.0 (21.6) | 151.9 (23.3) |
| AUC1-4 h for postprandial glucose (mg · h/dl) | 682.8 (91.2) | 680.4 (92.2) | 658.1 (116.2) |
| 24-hour mean glucose (mg/dl) | 184.1 (30.5) | 181.3 (25.9) | 178.4 (33.4) |
| Mean amplitude of glucose excursions, MAGE (mg/dl) | 91.4 (26.4) | 94.1 (18.5) | 89.1 (29.7) |
| Estimated glomerular filtration rate (ml/min/1.73 m2) (Japanese estimation equation [27]) | 82.6 (12.8) | 76.5 (11.1) | 80.7 (9.3) |
| Systolic blood pressure (mmHg)* | 119.8 (11.5) | 119.1 (15.9) | 124.0 (11.6) |
| Diastolic blood pressure (mmHg)* | 71.8 (7.7) | 70.7 (10.7) | 74.7 (8.0) |
Data are n (%) or mean (standard deviation). *Baseline for these parameters is day 1.