Table 1.
Baseline characteristics and demographics for randomized patients
| Characteristic | PBO (n = 80) | SITA 50 mg (n = 75) | All (n = 155) |
|---|---|---|---|
| Age (years) | 59.5 ± 10.3 | 60.2 ± 10.8 | 59.9 ± 10.5 |
| Gender, n (%) | |||
| Females | 21 (26.3) | 17 (22.7) | 38 (24.5) |
| Males | 59 (73.8) | 58 (77.3) | 117 (75.5) |
| Body weight, kg | 66.6 ± 12.8 | 69.1 ± 13.1 | 67.8 ± 13.0 |
| Body mass index, kg/m2 | 24.8 ± 3.5 | 25.6 ± 3.9 | 25.2 ± 3.7 |
| HbA1c (%) (range) | 8.4 ± 0.7 (7.3–10.2) | 8.6 ± 0.7 (7.2–10.5) | 8.5 ± 0.7 |
| Fasting plasma glucose, mg/dL | 167.1 ± 29.0 | 176.4 ± 39.1 | 171.6 ± 34.5 |
| 2-h postmeal glucose, mg/dL | 215.3 ± 54.7 | 223.3 ± 67.1 | 219.2 ± 61.0 |
| Duration of type 2 diabetes, years | 8.3 ± 4.9 | 9.0 ± 7.5 | 8.6 ± 6.3 |
| Type of glinide, n (%) | |||
| Nateglinide | 33 (41.3) | 28 (37.3) | 61 (39.4) |
| 180 mg/day | 1 (3.0) | 1 (3.6) | 2 (3.3) |
| 270 mg/day | 31 (93.9) | 25 (89.3) | 56 (91.8) |
| 360 mg/day | 1 (3.0) | 2 (7.1) | 3 (4.9) |
| Mitiglinide | 47 (58.8) | 47 (62.7) | 94 (60.6) |
| 15 mg/day | 4 (8.5) | 7 (14.9) | 11 (11.7) |
| 30 mg/day | 42 (89.4) | 39 (83.0) | 81 (86.2) |
| 45 mg/day | 1 (2.1) | 0 (0.0) | 1 (1.1) |
| 60 mg/day | 0 (0.0) | 1 (2.1) | 1 (1.1) |
Data are expressed as mean ± SD or n (%)
PBO placebo, SITA sitagliptin