MP-513 vs Saxagliptin

NCT00974090 · Phase 3 · completed

This was a randomized, quadruple-blind, placebo-controlled Phase 3 study of 194 adults with type 2 diabetes inadequately controlled on sulfonylurea therapy, with a 12-week double-blind period followed by a 40-week open-label extension. The primary endpoint - change from baseline in HbA1c at Week 12 - is a hard, regulator-accepted measure of glycemic control, and the comparison clearly favored teneligliptin (LS mean -0.71% vs +0.29% for placebo, SE 0.06 per arm), however statistical significance is not reported.

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.