Alogliptin vs Saxagliptin

NCT00286429 · Phase 3 · completed

The 390-participant trial was randomized, quadruple-blind, and placebo-controlled, with 130, 131, and 129 participants assigned to placebo, alogliptin 12.5 mg, and alogliptin 25 mg, respectively. Both primary HbA1c comparisons were statistically significant in favor of alogliptin, but HbA1c is a surrogate measure, so the evidence does not establish a strong clinical-outcome grade.

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.