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.
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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