MK 3102 meets endpoints in Phase III trial for T2D-Merck

Merck has announced the first data from the Phase III clinical development program for MK 3102 (omarigliptin), 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. The primary efficacy endpoint was the change in HbA1c1 levels from baseline at week 24. At baseline, randomized patients had a mean HbA1c concentration of 7.9, 8.0 and 8.1 percent in the omarigliptin, sitagliptin and placebo groups, respectively. Mean fasting plasma glucose levels were also similar between treatment groups.

The primary objectives of the study were met, demonstrating at 24 weeks a significant change from baseline in lowering HbA1c levels versus placebo, while demonstrating similar efficacy to sitagliptin. At week 24, omarigliptin significantly reduced HbA1c levels by -0.80 percent from baseline relative to placebo. The change relative to sitagliptin was -0.02 percent. There were no meaningful differences in the incidences of adverse events with omarigliptin compared to placebo and sitagliptin. These are the first Phase III data presented for omarigliptin and are the pivotal data for filing in Japan. Merck plans to file for approval in Japan by the end of 2014. Merck presented these data at the European Association for the Study of Diabetes Annual Meeting.