Table 1.
Demography and baseline characteristics (ITT population)
| Mean ± SD or n (%) | Vilda 50 mg bid + metformin | Glim 2 mg/day + metformin | Glim 6 mg/day + metformin | Glim “other” + metformin | Glim “overall” + metformin |
|---|---|---|---|---|---|
| N a | 1,539 | 417 | 589 | 514 | 1,520 |
| Age (years) | 57.5 ± 9.1 | 58.9 ± 9.2 | 56.3 ± 9.3 | 57.7 ± 9.1 | 57.5 ± 9.2 |
| Sex | |||||
| Male | 815 (53.0) | 222 (53.2) | 315 (53.5) | 278 (54.1) | 815 (53.6) |
| Female | 724 (47.0) | 195 (46.8) | 274 (46.5) | 236 (45.9) | 705 (46.4) |
| Race | |||||
| Caucasian | 1,343 (87.3) | 380 (91.1) | 482 (81.8) | 449 (87.4) | 1,311 (86.3) |
| Black | 18 (1.2) | 6 (1.4) | 6 (1.0) | 7 (1.4) | 19 (1.3) |
| Asian | 43 (2.7) | 9 (2.2) | 13 (2.2) | 22 (4.3) | 44 (2.9) |
| Hispanic/Latino | 128 (8.3) | 20 (4.8) | 79 (13.4) | 32 (6.2) | 131 (8.6) |
| All other | 7 (0.5) | 2 (0.5) | 9 (1.5) | 4 (0.8) | 15 (1.0) |
| HbA1c (%) | 7.3 ± 0.6 | 7.0 ± 0.5 | 7.5 ± 0.7 | 7.3 ± 0.6 | 7.3 ± 0.7 |
| FPG (mmol/L) | 9.1 ± 2.2 | 8.2 ± 1.6 | 9.9 ± 2.4 | 9.1 ± 2.1 | 9.2 ± 2.2 |
| BMI (kg/m2) | 31.9 ± 5.3 | 31.0 ± 5.2 | 32.4 ± 5.3 | 31.6 ± 5.2 | 31.7 ± 5.3 |
| Duration of T2DM (years) | 5.6 ± 5.1 | 5.3 ± 4.7 | 5.9 ± 5.0 | 5.8 ± 5.4 | 5.7 ± 5.1 |
| Metformin use | |||||
| Duration (years) | 3.0 ± 2.8 | 2.8 ± 2.8 | 3.0 ± 2.8 | 3.1 ± 3.1 | 3.0 ± 2.9 |
| Dose (mg/day) | 1,899 ± 411 | 1,853 ± 394 | 1,902 ± 407 | 1,900 ± 421 | 1,888 ± 409 |
| GFR (MDRD) (mL/min/1.73 m2) | |||||
| Normal (>80) | 1,050 (68.2) | 272 (65.2) | 432 (73.3) | 330 (64.2) | 1,034 (68.0) |
| Mild (≥50 to ≤80) | 474 (30.8) | 142 (34.1) | 153 (26.0) | 181 (35.2) | 476 (31.3) |
| Moderate (≥30 to <50) | 13 (0.8) | 3 (0.7) | 4 (0.7) | 3 (0.6) | 10 (0.7) |
| Severe (<30) | 1 (0.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Missing | 1 (0.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
BMI body mass index, FPG fasting plasma glucose, Glim glimepiride, GFR glomerular filtration rate, HbA 1c glycated hemoglobin, MDRD modification of diet in renal disease, T2DM type 2 diabetes mellitus, Vilda vildagliptin
a N (BMI) = 1,534 (Vilda 50 mg bid), 414 (Glim 2 mg/day), 588 (Glim 6 mg/day), 511 (Glim ‘other’) and 1,513 (Glim ‘overall’); N (FPG) = 1,536 (Vilda 50 mg bid), 417 (Glim 2 mg/day), 588 (Glim 6 mg/day), 514 (Glim ‘other’) and 1,519 (Glim ‘overall’)