The FINANCIAL — Merck, known as MSD outside the United States and Canada, on September 16 announced that omarigliptin, Merck’s investigational once-weekly DPP-4 inhibitor in development for adults with type 2 diabetes, achieved its primary efficacy endpoint in a Phase 3 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, according to Merck.
“Type 2 diabetes is a chronic, progressive disease that affects millions of Americans2, and its prevalence continues to grow rapidly. Many people are still not at their recommended blood sugar levels, underscoring the importance of individualized blood sugar goals and multiple treatment options,” said Sam Engel, M.D., associate vice president, Merck clinical research, diabetes and endocrinology. “Omarigliptin has the potential to be an important treatment option, particularly for those who also prefer once-weekly dosing.”
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 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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