Omarigliptin efficacy, safety similar to sitagliptin

Similar efficacy and safety was found between once-weekly omarigliptin and once-daily sitagliptin among patients with type 2 diabetes, according to a presenter at the 50th European Association for the Study of Diabetes Annual Meeting.

“Omarigliptin is a potent, highly selective oral DPP-IV inhibitor,” Ira Gantz, MD, a clinical researcher for metabolism at Merck Research Laboratories, said during his presentation. “Its pharmacokinetic and pharmacodynamics profile allows for once-weekly dosing. One of the challenges in the treatment of chronic diseases is medication adherence. Pill burden and dosing complexity are factors that can contribute to poor medication adherence. The convenience of an effective, well-tolerated, weekly, oral antihyperglycemic agent has the potential to improve patient adherence, which might translate to better glycemic control and disease outcomes.”

Ira Gantz

Gantz and colleagues conducted a double blind, parallel-group, active and placebo-controlled trial to evaluate the safety and efficacy of omarigliptin compared with placebo and sitagliptin (Januvia, Merck).

The study population included Japanese adults (aged at least 20 years) with type 2 diabetes who were randomly assigned to one of three treatment groups: once-weekly omarigliptin 25 mg (n=166), once-daily sitagliptin 50 mg (n=165) or placebo (n=82). A mixed-meal tolerance test was performed the day before administering the study drug and again at 24 weeks, 1 day after the last dose of sitagliptin or 7 days after the last dose of omarigliptin.

At baseline, mean HbA1c concentrations and mean fasting plasma glucose levels were similar among the three groups.

Omarigliptin resulted in a significant reduction in HbA1c compared with placebo at week 24 (–0.8%; P<.001). The majority of this treatment effect was seen by week 12. HbA1c reduction was noninferior between omarigliptin and sitagliptin (P=.792). Compared with placebo, patients on omarigliptin were more likely to achieve HbA1c levels <7% or <6.5% at week 24.

Two-hour postmeal glucose also was significantly reduced by omarigliptin compared with placebo at 24 weeks (–2.05 mmol/L; P<.001). Similarly, omarigliptin significantly reduced FPG compared with placebo (–0.68 mmol/L; P<.001).

No deaths or serious adverse events were reported throughout the study period.

“Omarigliptin 25 mg once weekly achieved statistically significant HbA1c lowering compared with placebo. HbA1c lowering was similar to that of sitagliptin 50 mg once daily, and compared with placebo, omarigliptin significantly reduced 2-hour postmeal glucose and FPG. Omarigliptin was well tolerated with no hypoglycemia and no change in body weight,” Gantz said. “In conclusion, in Japanese subjects with type 2 diabetes treatment with once-weekly omarigliptin over 24 weeks resulted in statistically significant and clinically meaningful improvements in glycemic control and was generally well tolerated. The glycemic efficacy and safety profile of once-weekly omarigliptin is similar to that of once-daily sitagliptin.”

For more information:

Gantz I. Abstract #115. Presented at: 50th EASD Annual Meeting; Sept. 16-19, 2014; Vienna.

Disclosure: All researchers report financial ties with Merck. The study was funded by MSD KK, the Japan subsidiary of Merck.