Saxagliptin vs Teneligliptin

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.

NCT00974090 · Phase 3 · completed

The trial was properly randomized and double-blinded with a placebo control and a real hard clinical endpoint (HbA1c change), and enrollment (~96-98 per arm) was reasonable for a 12-week phase 3 add-on study. However, the posted results report only least-squares mean changes with standard errors and no explicit statistical significance test for the primary comparison, so while the numeric difference favors teneligliptin, whether it formally met its pre-specified endpoint cannot be confirmed from this record alone.