Merck, Pfizer Announce Ertugliflozin Meets Primary Endpoint In Phase 3 Study

(RTTNews) - Merck (MRK), in partnership with Pfizer Inc. (PFE) announced that a Phase 3 study of ertugliflozin, an investigational oral SGLT2 inhibitor for the treatment of patients with type 2 diabetes, met its primary endpoint. Both 5 mg and 15 mg daily doses of ertugliflozin showed significantly greater reductions in A1C compared with placebo, when added to patients on a background of sitagliptin and stable metformin. Overall adverse event rates were generally similar between ertugliflozin 5 mg, ertugliflozin 15 mg and placebo, with a similar rate of one or more serious adverse events across all groups.

The companies plan to submit New Drug Applications to the U.S. FDA for ertugliflozin and two fixed-dose combinations by the end of 2016, with additional regulatory submissions outside of the U.S. to follow in 2017.