Gemigliptin vs Saxagliptin

NCT01787396 · Phase 3 · completed

This was a randomized, quadruple-blind trial (n=433) with three arms: gemigliptin plus metformin, gemigliptin alone (with a matching metformin placebo), and metformin alone (with a matching gemigliptin placebo). The primary endpoint, HbA1c change at 24 weeks, favored the combination over either monotherapy.

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.