Merck Posts Positive Phase 3 Data For Diabetes Drug In Japan

Merck presented positive data from its Phase 3 trials for omarigliptin in Japanese patients with Type 2 diabetes. The company shared the study results at the 50th European Association for the Study of Diabetes (EASD) Annual Meeting.

Omarigliptin is an investigational once-weekly DPP-4 inhibitor for the treatment of Type 2 diabetes. Merck is undertaking a global clinical development program for the drug comprised of 10 Phase 3 clinical trials that have enrolled 8,000 patients with T2D.

According to a study by the National Institutes of Health (NIH), approximately 13.5 percent of the Japanese population has Type II diabetes. The double-blind, non-inferiority Phase 3 trial in Japanese patients investigated omarigliptin’s safety, efficacy, and tolerability compared to the starting dose of sitagliptin in Japan and placebo. The trial’s primary endpoint was change from baseline in HbA1c1 levels at week 24 of the study. Results show that omarigliptin was non-inferior to sitagliptin and achieved a significant decrease in HbA1c1 levels compared to placebo. Omarigliptin also demonstrated sustained DPP-4 inhibition in the study.

“Despite advances in diabetes care in recent years, many people living with type 2 diabetes are not at recommended blood sugar goals… If approved, omarigliptin, as a once-weekly medication, could provide an important new treatment option to help patients attain their blood sugar goals,” said Peter Stein, VP of Clinical Research, Diabetes, and Endocrinology, at Merck Research Laboratories.

The results are the first Phase 3 data for the drug revealed by the company. Merck said it will use the findings as pivotal data to support its regulatory filing in Japan by the end of the year.

Merck previously investigated sitagliptin, marketed under the brand name Januvia, in combination with other products. In 2009, Merck and Pfizer collaborated to investigate sitagliptin in a potential combination with Pfizer's experimental T2D drug ertugliflozin. Januvia is also marketed alongside Janumet (metformin) as a combo therapy for the disease.