Gosogliptin vs Saxagliptin

NCT03088670 · Phase 3 · completed

The study used randomization and an active comparator, but it was open-label and its primary endpoint was change in HbA1c, a surrogate measure rather than a hard clinical outcome. Registry results were not posted at the time of grading; the key result shown was recovered from the cited external source.

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.