Merck announced the presentation of the first data from the Phase 3 clinical development program 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, 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 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, Merck plans to file for approval in Japan by the end of 2014.
The Phase 3 double-blind, non-inferiority trial assessed the efficacy, safety and tolerability of omarigliptin 25 mg once-weekly compared to sitagliptin 50 mg once-daily (standard starting dose in Japan), and to placebo. 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% in the omarigliptin, sitagliptin and placebo groups, respectively. Mean fasting plasma glucose (FPG) 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% from baseline relative to placebo. The change relative to sitagliptin was -0.02% and met the prespecified non-inferiority criterion. The pre-specified criterion was based on the upper bound of the 95% confidence interval (CI) being less than 0.3%. Fasting and two-hour post-meal blood sugar levels also were significantly reduced from baseline with omarigliptin and sitagliptin compared to placebo.
There were no meaningful differences in the incidences of adverse events with omarigliptin compared to placebo and sitagliptin. The most common adverse event that occurred with an incidence of greater than 3% in the omarigliptin group was nasopharyngitis, which occurred in 12.7% of those treated, compared to 30.5% of patients receiving placebo and 11.0% of those receiving sitagliptin. Symptomatic hypoglycemia was uncommon across all treatment groups in this study [omarigliptin (0), sitagliptin (1), and placebo (0)]. Omarigliptin was generally weight neutral, with a 0.04 kg mean change from baseline at week 24.
Date: September 17, 2014