Table 1.
Patient disposition, demographics and baseline characteristics in the randomized set
| Characteristic | Alogliptin (N = 222) | Glipizide (N = 219) |
|---|---|---|
| Study populations, n (%) | ||
| Safety set | 222 (100) | 219 (100) |
| Per-protocol set | 180 (81) | 162 (74) |
| Geographic region, n (%) | ||
| North America | 62 (28) | 65 (30) |
| Latin America | 59 (27) | 54 (25) |
| Europe, rest of the world | 101 (46) | 100 (46) |
| Baseline HbA1c, n (%) | ||
| <8.0% | 168 (76) | 170 (78) |
| ≥8.0% | 54 (24) | 49 (22) |
| Sex, n (%) | ||
| Male | 102 (46) | 96 (44) |
| Age | ||
| Mean ± SD, years | 70.1 ± 4.4 | 69.8 ± 4.1 |
| Median (minimum–maximum), years | 69.0 (65–86) | 69.0 (65–87) |
| <75 years, n (%) | 186 (84) | 193 (88) |
| ≥75 years, n (%) | 36 (16) | 26 (12) |
| Race, n (%) | ||
| American Indian or Alaskan Native | 12 (5) | 13 (6) |
| Asian | 19 (9) | 26 (12) |
| Black or African American | 16 (7) | 20 (9) |
| White | 169 (76) | 154 (70) |
| Multiracial | 6 (3) | 6 (3) |
| Mean ± SD weight, kg | 78.6 ± 14.8 | 78.8 ± 15.2 |
| Mean ± SD BMI, kg/m2 | 29.6 ± 4.6 | 30.0 ± 4.5 |
| Mean ± SD diabetes duration, years | 6.25 ± 6.3 | 5.94 ± 6.3 |
| Mean ± SD HbA1c, % (n)a | 7.5 ± 0.7 (215) | 7.5 ± 0.6 (214) |
| Mean ± SD GFR, mL/min/1.73 m2 | ||
| MDRD | 74 ± 15 | 73 ± 16 |
| Cockcroft–Gault | 78.3 ± 18 | 78 ± 20 |
BMI body mass index, GFR glomerular filtration rate, HbA1c glycosylated hemoglobin, MDRD Modification of Diet in Renal Disease, SD standard deviation
aEvaluated using all randomized and treated participants with available HbA1c data after baseline