September 15, 2016
Merck, in partnership with Pfizer Inc., has announced that a Phase 3 study (VERTIS SITA2) of ertugliflozin, an investigational oral SGLT2 inhibitor for the treatment of patients with type 2 diabetes, met its primary endpoint. Both 15 mg and 5 mg daily doses of ertugliflozin revealed meaningfully greater reductions in A1C of 0.69 percent and 0.76 percent, respectively, in comparison with placebo (p<0.001, for both comparisons), when added to patients on a background of stable metformin (≥1500 mg/day) and sitagliptin (100 mg/day). For the first time, these study results were presented during an oral session at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany.
By the end of 2016, Merck and Pfizer plan to submit New Drug Applications to the U.S. Food and Drug Administration for ertugliflozin and two fixed-dose combinations (ertugliflozin plus JANUVIA® (sitagliptin) and ertugliflozin plus metformin), with additional regulatory submissions outside of the U.S. to follow in 2017.
Peter Stein, M.D., vice president, late stage development, diabetes and endocrinology, Merck, said: “It is encouraging to see further data from the VERTIS clinical development program in support of combining ertugliflozin, an SGLT2 inhibitor, with the DPP-4 inhibitor sitagliptin, which was first approved 10 years ago.”
“We are pleased to share these new data on investigational ertugliflozin with the scientific community, following the first presentations of Phase 3 data for ertugliflozin at the American Diabetes Association’s 76th Scientific Sessions in June. Type 2 diabetes is a progressive disease and these study results help support the clinical profile of ertugliflozin as an add-on therapy for patients who may require multiple treatment combinations to help reach their blood sugar goals,” said James Rusnak, M.D., Ph.D., chief development officer, cardiovascular & metabolics, Pfizer.