DBPR108 vs Saxagliptin

NCT04161430 · Phase 3 · completed

In this randomized, quadruple-blind, placebo- and active-controlled Phase 3 trial, 766 patients with type 2 diabetes were randomized to DBPR108, sitagliptin, or placebo. DBPR108 reduced HbA1c significantly more than placebo at 24 weeks, with a treatment difference whose confidence interval excluded no effect.

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.