Merck, Pfizer to Release NDAs for Diabetes Drug Combinations After Phase III Trial

Merck and Pfizer announced that a Phase III study of ertugliflozin met its primary endpoint, demonstrating greater reductions in A1C in type 2 diabetes compared to placebo.

Both 5 mg and 15 mg daily doses of ertugliflozin showed reductions of 0.69 percent and 0.76 percent, respectively, when added to patients on a background of Januvia (sitagliptin) and stable metformin. Ertugliflozin also met secondary endpoints, showing reductions in body weight, systolic blood pressure, and fasting plasma glucose levels.

Merck and Pfizer plan to submit NDAs for ertugliflozin, as well as two combinations—ertugliflozin plus Januvia, and ertugliflozin plus metformin—by the end of the year, with international submissions planned for 2017.