Table 4.
Mean changes in HbA1c (%) from baseline to endpoint by subgroups (full analysis set)
| Subgroups | Vildagliptin + metformin n = 68 | Placebo + metformin n = 70 | ||||
|---|---|---|---|---|---|---|
| n | BL mean | Change (SE) | N | BL mean | Change (SE) | |
| Age (years) | ||||||
| <65 | 47 | 7.9 | −1.1 (0.08) | 54 | 8.0 | −0.1 (0.08) |
| ≥65 | 21 | 8.3 | −1.1 (0.15) | 16 | 7.9 | −0.2 (0.08) |
| Gender | ||||||
| Male | 44 | 7.9 | −1.0 (0.10) | 48 | 8.1 | −0.2 (0.07) |
| Female | 24 | 8.2 | −1.2 (0.09) | 22 | 7.9 | −0.1 (0.13) |
| BMI (kg/m2) | ||||||
| <25 | 32 | 8.0 | −1.2 (0.11) | 35 | 7.8 | −0.2 (0.08) |
| ≥25 | 36 | 8.0 | −0.9 (0.08) | 35 | 8.2 | 0.0 (0.10) |
| HbA1c (%) | ||||||
| ≤8 | 40 | 7.4 | −0.9 (0.07) | 40 | 7.3 | 0.0 (0.08) |
| >8 to ≤9 | 17 | 8.3 | −1.1 (0.14) | 14 | 8.5 | 0.0 (0.10) |
| >9 | 11 | 9.5 | −1.6 (0.26) | 16 | 9.4 | −0.3 (0.17) |
| FPG (mmol/L) | ||||||
| <8.9 | 41 | 7.6 | −1.0 (0.08) | 34 | 7.3 | −0.1 (0.06) |
| ≥8.9 | 27 | 8.6 | −1.2 (0.14) | 36 | 8.7 | −0.1 (0.11) |
BL baseline, BMI body mass index, FPG fasting plasma glucose, HbA 1c glycosylated hemoglobin, SE standard error