Table 1.
Vildagliptin 50 mg bid | Placebo | |
n = 87 | n = 86 | |
Age, years | 54.0 ± 8.4 | 54.9 ± 10.5 |
≥ 65, n (%) | 8 (9.2) | 13 (15.1) |
Gender, female, n (%) | 45 (51.7) | 39 (45.3) |
Race, n (%) | ||
Indian (Indian subcontinent) | 62 (71.3) | 61 (70.9) |
Chinese | 24 (27.6) | 24 (27.9) |
Other | 1 (1.1) | 1 (1.2) |
BMI, kg/m2 | 26.2 ± 3.0 | 26.7 ± 3.7 |
Body weight, kg | 67.5 ± 9.5 | 68.8 ± 12.1 |
HbA1c, % (mmol/mol) | 8.9 ± 1.0 | 9.0 ± 1.0 |
(73.7 ± 10.9) | (74.8 ± 10.9) | |
FPG, mmol/L | 9.1 ± 2.6 | 8.6 ± 2.5 |
T2DM duration, years | 11.1 ± 6.4 | 12.1 ± 7.6 |
GFR, mL/min per 1.73 m2, n (%) | ||
Normal, > 80 | 43 (49.4) | 52 (60.5) |
Mild, ≥ 50 to ≤ 80 | 42 (48.3) | 33 (38.4) |
Moderate, ≥ 30 to < 50 | 2 (2.3) | 1 (1.2) |
Background antidiabetic therapy | ||
Insulin use at screening, n (%) | ||
Intermediate-acting | 21 (24.1) | 20 (23.3) |
Long-acting | 14 (16.1) | 8 (9.3) |
Pre-mixed | 52 (59.8) | 58 (67.4) |
Duration of insulin use, years | 3.3 ± 2.9 | 3.9 ± 4.3 |
Daily dose of insulin, U | 39.5 ± 15.8 | 39.5 ± 15.3 |
Daily number of insulin injections | 1.9 ± 0.4 | 1.8 ± 0.4 |
Metformin use at screening, n (%) | ||
Yes | 52 (59.8) | 52 (60.5) |
No | 35 (40.2) | 34 (39.5) |
Values are mean ± SD unless indicated otherwise. BMI: Body mass index; GFR: Glomerular filtration rate; FPG: Fasting plasma glucose; HbA1c: Hemoglobin A1c; T2DM: Type 2 diabetes mellitus.