MSD presents first Phase 3 data in Japanese patients for Omarigliptin, an investigational once-weekly DPP-4 inhibitor for Type 2 Diabetes Omarigliptin significantly reduced HbA1c levels compared to placebo

MSD, known as Merck & Co., Inc. (NYSE: MRK) in the United States and Canada, today announced the presentation of the first data from the Phase 3 clinical development programme for omarigliptin, MSD’s investigational treatment for type 2 diabetes. In a study in Japanese patients, omarigliptin provided comparable efficacy and tolerability to MSD’s once-daily DPP-4 inhibitor, Januvia® (sitagliptin) 50 mg, which is the standard starting dose for sitagliptin in Japan.¹ MSD presented these data on omarigliptin, which has been shown to produce sustained DPP-4 inhibition, at an oral session at the 50th European Association for the Study of Diabetes (EASD) Annual Meeting.

“Despite advances in diabetes care in recent years, many people living with type 2 diabetes are not at recommended blood sugar goals,” said Peter Stein, M.D., vice president, Global Clinical Research, Diabetes and Endocrinology, Merck Research Laboratories. “MSD is committed to helping patients reduce the complexities of managing diabetes. If approved, omarigliptin, as a once-weekly medication, could provide an important new treatment option to help patients attain their blood sugar goals.”

MSD is supporting omarigliptin with a global clinical development programme that includes 10 Phase 3 clinical trials involving approximately 8,000 patients with type 2 diabetes. These are the first Phase 3 data presented for omarigliptin and are the pivotal data for filing in Japan. As previously announced, MSD plans to file for approval in Japan by the end of 2014.

Reference

¹ Gantz, I et al. Effect of a novel once weekly DPP-4 inhibitor, omarigliptin in patients with type 2 diabetes: a double-blind, placebo and sitagliptin-controlled, non-inferiority trial. Presentation 115, presented at 50th EASD Annual Meeting on September 17 2014. Available at http://www.easd.org/images/easdwebfiles/annualmeeting/50thmeeting/Prog-at-Glance.html. Last accessed September 2014