Linagliptin vs Saxagliptin

NCT00602472 · Phase 3 · completed

This was a randomized, double-blind, placebo-controlled trial with 1,058 participants, and its primary endpoint was met: adjusted HbA1c change was −0.72% with linagliptin versus −0.10% with placebo (p<0.0001). The evidence is considered moderate because HbA1c is a surrogate measure rather than a hard clinical endpoint.

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.