Omarigliptin vs Saxagliptin

NCT01682759 · Phase 3 · completed

This trial randomized 751 patients in double-blind fashion to omarigliptin or an active comparator (glimepiride), both added to background metformin, for 54 weeks. The primary endpoint was change in HbA1c (a regulator-accepted, disease-defining measure for diabetes), and the prespecified non-inferiority margin of 0.35% was met: the upper bound of the 95% confidence interval for the treatment difference (0.30%) fell within the margin. The trial was adequately sized, properly blinded, and its primary comparison succeeded as designed, making this strong controlled evidence for omarigliptin, even though omarigliptin showed a numerically smaller HbA1c reduction than glimepiride.

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.