Saxagliptin vs Sitagliptin

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.

NCT00087516 · Phase 3 · completed

The trial randomized 741 participants to double-blind sitagliptin or placebo groups, providing a substantial controlled comparison. The primary endpoint, change in A1C at week 24, was statistically favorable for both sitagliptin doses (p<0.001), but A1C is a surrogate endpoint, so the evidence is rated moderate rather than strong.