Merck announced results from the Phase 3 clinical program for omarigliptin, once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes.

The double-blind, non-inferiority trial assessed the efficacy, safety and tolerability of omarigliptin 25mg once-weekly compared to Januvia (sitagliptin) 50mg once-daily and to placebo. The primary efficacy endpoint was the change in HbA1c levels from baseline at week 24.

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The primary objectives of the study were met, demonstrating at 24 weeks a significant change from baseline in lowering HbA1c levels vs. placebo, while demonstrating similar efficacy to sitagliptin. At week 24, omarigliptin significantly reduced HbA1c levels by -0.80% from baseline relative to placebo. The change relative to sitagliptin was -0.02% and met the prespecified non-inferiority criterion. Fasting and two-hour post-meal blood sugar levels also were significantly reduced from baseline with omarigliptin and sitagliptin compared to placebo.

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