Merck Presents First Phase III Data in Japanese Patients for Omarigliptin for Type 2 Diabetes

Merck (MSD outside the US and Canada) has announced the presentation of the first data from the Phase III clinical development programme for omarigliptin, Merck’s investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes. In a study in Japanese patients, omarigliptin provided comparable efficacy and tolerability to Merck’s once-daily DPP-4 inhibitor JANUVIA (sitagliptin) 50 mg, which is the standard starting dose for sitagliptin in Japan. Merck 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, MD, Vice President, Clinical Research, Diabetes and Endocrinology, Merck Research Laboratories. “Merck 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.”

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