MP-513 vs Omarigliptin

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.

NCT01682759 · Phase 3 · completed

This trial randomized 751 patients in double-blind fashion to omarigliptin or an active comparator (glimepiride), both added to background metformin, for 54 weeks. The primary endpoint was change in HbA1c (a regulator-accepted, disease-defining measure for diabetes), and the prespecified non-inferiority margin of 0.35% was met: the upper bound of the 95% confidence interval for the treatment difference (0.30%) fell within the margin. The trial was adequately sized, properly blinded, and its primary comparison succeeded as designed, making this strong controlled evidence for omarigliptin, even though omarigliptin showed a numerically smaller HbA1c reduction than glimepiride.