Saxagliptin vs SYR-472

NCT00121667 · Phase 3 · completed

Large randomized, double-blind, placebo-controlled phase 3 trial (743 treated participants across three saxagliptin doses and one placebo arm, all on background metformin). The primary endpoint was change from baseline in hemoglobin A1c at Week 24, an accepted hard glycemic measure for type 2 diabetes, and every saxagliptin dose showed a statistically significant improvement versus placebo (adjusted differences of -0.73, -0.83, and -0.72 percentage points, each p<0.0001). Because the trial was adequately powered, double-blind, and placebo-controlled, and the primary comparison was met, this is strong evidence for saxagliptin's efficacy.

NCT02324569 · Phase 3 · completed

The 12-week comparison randomized 240 participants and used quadruple blinding with placebo control. The primary HbA1c endpoint was met, with a statistically significant treatment difference, but HbA1c is a surrogate laboratory measure rather than a hard clinical endpoint; the subsequent long-term period was open-label.