Patient characteristics at the screening visit
| Placebo (n=33) | 10 mg DS-8500a (n=32) | 75 mg DS-8500a (n=34) | |
| Age (years) | 55.7±9.1 | 58.3±7.4 | 57.7±7.2 |
| Sex | |||
| Women | 3 (9.1) | 2 (6.3) | 6 (17.6) |
| Men | 30 (90.9) | 30 (93.8) | 28 (82.4) |
| Body mass index (kg/m2) | 25.07±3.39 | 24.78±2.50 | 24.97±3.41 |
| Diabetes duration (years) | 6.95±6.03 | 6.25±5.03 | 7.44±5.50 |
| Prior oral antidiabetic drug | 5 (15.2) | 6 (18.8) | 5 (14.7) |
| Sulfonylurea | 2 (6.1) | 0 (0.0) | 2 (5.9) |
| Biguanide | 0 (0.0) | 2 (6.3) | 1 (2.9) |
| DPP-4 inhibitor | 3 (9.1) | 4 (12.5) | 2 (5.9) |
| Use of lipid-lowering drug | 4 (12.1) | 2 (6.3) | 5 (14.7) |
| Statin | 3 (9.1) | 2 (6.3) | 4 (11.8) |
| Fibrate | 1 (3.0) | 0 (0.0) | 1 (2.9) |
| HbA1c (% (mmol/mol)) | 7.92±0.62 (63±6.8) | 8.12±0.55 (65±6.0) | 8.01±0.79 (64±8.6) |
| HbA1c ≤8% (64 mmol/mol) | 21 (63.6) | 15 (46.9) | 19 (55.9) |
| HbA1c >8% (64 mmol/mol) | 12 (36.4) | 17 (53.1) | 15 (44.1) |
| FPG (mmol/L) | 8.59±1.535 | 9.17±1.648 | 8.60±1.920 |
| 24-hour WMG (mmol/L) | 11.08±1.925 | 11.59±2.017 | 11.26±2.468 |
Results are shown as mean±SD or n (%) for the full analysis set.
DPP-4, dipeptidyl peptidase-4; FPG, fasting plasma glucose; WMG, weighted mean glucose.