Merck announced that omarigliptin, its investigational once-weekly DPP-4 inhibitor in development for adults with type 2 diabetes, achieved its primary efficacy endpoint in a Phase 3 study. According to a press release, 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.
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 U.S. by the end of 2015, the release said. The clinical development program for omarigliptin, O-QWEST (Omarigliptin Q Weekly Efficacy and Safety in Type 2 Diabetes), includes 10 Phase 3 clinical trials involving approximately 8,000 patients with type 2 diabetes.
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