Table 3.
Primary and secondary efficacy and tolerability end-points (PP population)
| Success rate vildagliptin N = 28,061 | Non-evaluable vildagliptin | Success rate comparator N = 15,294 | Non-evaluable comparator | OR unadjusted (95%CI) | Adjusted OR (95% CI) | p-value | |
|---|---|---|---|---|---|---|---|
| Primary end-point (PEP) Decrease HbA1c > 0.3%, no hypoglycaemia, no significant weight gain (≥ 5%), no discontinuation for GI events, no peripheral oedema | 15,536 (55.4) | 7631 (27.2) | 7852 (51.3) | 3562 (23.3) | 1.18 (1.13, 1.22) | 1.49 (1.42, 1.55) | < 0.001 |
| Secondary end-point 1 (SEP 1) Decrease HbA1c > 0.3%, no hypoglycaemia, no weight gain (≥ 3%), no discontinuation for GI events, no peripheral oedema | 15,066 (53.7) | 7584 (27.0) | 7170 (46.9) | 3543 (23.2) | 1.31 (1.26, 1.37) | 1.64 (1.57, 1.72) | < 0.001 |
| Secondary end-point 2 (SEP 2) Decrease in HbA1c > 0.3% from BL to EOS without ≥ 3% weight gain or hypoglycaemia | 15,071 (53.7) | 7635 (27.2) | 7177 (46.9) | 3568 (23.3) | 1.31 (1.26, 1.36) | 1.64 (1.57, 1.72) | < 0.001 |
| Secondary end-point 3 (SEP 3) In patients with BL HbA1c > 7%, HbA1c < 7% at EOS without hypoglycaemia or weight gain ≥ 3% | 8027 (35.1) | 4695 (20.5) | 2940 (23.2) | 2076 (16.4) | 1.79 (1.70, 1.88) | 1.96 (1.85, 2.07) | < 0.001 |
GI, gastrointestinal; BL, baseline; EOS, End of Study.