Phase III trial of MK 3102 (omarigliptin) in type 2 diabetes meets endpoint- Merck

Merck announced that MK 3102 (omarigliptin), a once-weekly DPP-4 inhibitor in development for adults with type 2 diabetes, achieved its primary efficacy endpoint in a Phase III study. Omarigliptin was found to be non-inferior to Merck�s once-daily DPP-4 inhibitor, Januvia (sitagliptin), at reducing patients� A1C* levels from baseline, with similar A1C reductions achieved in both groups. The head-to-head study was designed to evaluate once-weekly treatment with omarigliptin 25 mg compared to 100 mg of Januvia once daily, a widely prescribed DPP-4 inhibitor worldwide. Results were presented during an oral session at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting.

Comment: Merck submitted a new drug application to the Japanese Pharmaceuticals and Medical Devices Agency in November 2014 and plans to submit for regulatory approval of omarigliptin in the US by the end of 2015. The clinical development program for omarigliptin, O-QWEST, includes 10 Phase III clinical trials involving approximately 8,000 patients with type 2 diabetes.