Table 1.
Demographic and baseline characteristics (randomized population)
| Demographic variable | Vilda 100 mg qd/metformin 500 mg bid N = 456 | Metformin up to 1000 mg bid N = 458 | Total N = 914 |
| Gender; female, n (%) | 226 (49.6) | 252 (55) | 478 (52.3) |
| Age; mean ± SD (years) | 56.9 ± 9.76 | 57.0 ± 10.02 | 57.0 ± 9.89 |
| Age group (≥ 65 years), n (%) | 106 (23.2%) | 114 (24.9%) | 220 (24.1%) |
| Race | |||
| Caucasian | 242 (53.1%) | 237 (51.7%) | 479 (52.4%) |
| Asian (non-indian subcontinent) | 44 (9.6%) | 44 (9.6%) | 88 (9.6%) |
| Hispanic or latino | 147 (32.2%) | 145 (31.7%) | 292 (31.9%) |
| Black | 9 (2.0%) | 12 (2.6%) | 21 (2.3%) |
| Asian (indian subcontinent) | 3 (0.7%) | 5 (1.1%) | 8 (0.9%) |
| Native american | 1 (0.2%) | 2 (0.4%) | 3 (0.3%) |
| Other | 10 (2.2%) | 13 (2.8%) | 23 (2.5%) |
| Body weight; mean ± SD (kg) | 84.6 ± 17.01 | 84.4 ± 18.94 | 84.5 ± 17.99 |
| BMI (kg/m2); mean ± SD | 31.1 ± 5.11 | 31.2 ± 5.47 | 31.1 ± 5.29 |
| HbA1c (%); mean ± SD | 7.4 ± 0.78 | 7.3 ± 0.79a | 7.3 ± 0.79 |
| FPG (mmol/L); mean ± SD | 8.7 ± 2.28 | 8.5 ± 2.25 | 8.6 ± 2.27 |
| Duration of type 2 diabetes; mean ± SD (years) | 4.6 ± 4.91 | 4.7 ± 4.94 | 4.7 ± 4.92 |
Demographic information is collected on the day of the screening measurement (Week-4, Visit 1).
a
Hemoglobin A1c (HbA1c) measurements at Visit 1 not available for one patient (n = 457). FPG: Fasting plasma glucose; BMI: Body mass index.