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Phase II Trials for Omarigliptin Prove Hopeful for Phase III Trials

Sep 18, 2015

Research was recently published inDiabetes Care as a Phase II study to determine optimal dosing, tolerability and efficacy of a new, once-weekly DPP-4 inhibitor called omarigliptin. Over 12 weeks, the researchers looked at HbA1C, 2-hour postprandial glucose and fasting glucose.

Currently, the DPP-4 inhibitors on the market are all once-daily. A once-weekly DPP-4 inhibitor may prove useful for patients who are non-adherent. Patients who finished the 12-week study were able to enter a 66-week extension of the study.
Throughout the long-term study, patients were dosed on 0.25mg, 1mg, 3mg, 10mg and 25mg once weekly. Hypoglycemia was rare and the drug was well tolerated at a dose of 25 mg once-weekly. Furthermore, omarigliptin appeared to be weight neutral with no significant effects on body weight.

During the complete 78 weeks, omarigliptin proved to be comparable in safety to placebo and metformin. After 12 weeks of treatment, all doses showed significant A1C (-0.72%) and postprandial glucose (-2.5 mmol/L) reductions when compared to placebo. All doses greater than 1 mg reduced fasting glucose (-1.3 mmol/L) better than placebo.
In the 485 patients who completed the 66-week extension of the study, there were no reported severe hypoglycemia events or acute or chronic pancreatitis.

Overall, omarigliptin, dosed at 25mg once weekly, proved safe and effective for type 2 diabetes patients in this Phase II study. Further Phase III trials will test this dose further and assess the usefulness of using a once-weekly diabetes medication in patient adherence.

Practice Pearls:

  • A 78-week Phase II trial was conducted to test dosing, safety and efficacy of a new once-weekly DPP-4 inhibitor called omarigliptin.
  • The study found that 25 mg of omarigliptin once weekly was well-tolerated with hypoglycemia being rare and the drug appearing weight neutral.
  • A1C reductions were reported as -0.72% compared to placebo and further Phase III trials will evaluate this efficacy and patient adherence moving forward.

Sheu, Wayne H.-H., Ira Gantz, Menghui Chen, et al. “Safety and Efficacy of Omarigliptin (MK-3102), a Novel Once-Weekly DPP-4 Inhibitor for the Treatment of Patients With Type 2 Diabetes.” Diabetes Care Dia Care (2015): Dc150109. Web. 10 Sept. 2015. .