Ertugliflozin shows significant A1C reductions in type 2 diabetes

Merck and Pfizer have announced that two Phase III studies (VERTIS Mono and VERTIS Factorial) of ertugliflozin, an investigational oral SGLT-2 inhibitor for the treatment of patients with type 2 diabetes, met their primary endpoints.

VERTIS Mono, a 26-week investigational study which evaluated ertugliflozin as monotherapy, met its primary endpoint, showing that patients randomized to ertugliflozin 5 mg and 15 mg had significantly greater A1C reductions of 0.99 percent and 1.16 percent, respectively, compared with placebo. In addition, significantly more patients taking ertugliflozin 5 mg and 15 mg achieved the A1C treatment goal of less than 7.0 percent (28.2 percent and 35.8 percent, respectively) compared with placebo (13.1 percent), which was a secondary endpoint of the study.

VERTIS Factorial, another 26-week investigational study, evaluated the co-administration of ertugliflozin and Merck’s DPP-4 inhibitor Januvia (sitagliptin). This study also met its primary endpoint, with greater reductions in A1C observed in patients taking ertugliflozin in combination with sitagliptin compared to ertugliflozin or sitagliptin alone. An A1C reduction of 1.5 percent was observed in both combinations studied (ertugliflozin 5 mg or 15 mg with sitagliptin 100 mg), as compared with A1C reductions of 1.0 percent with ertugliflozin 5 mg alone, 1.1 percent with ertugliflozin 15 mg alone, and 1.1 percent with sitagliptin 100 mg alone.

Ertugliflozin and sitagliptin “significantly more effective”

In addition, the co-administration of ertugliflozin and sitagliptin was significantly more effective than ertugliflozin or sitagliptin alone in achieving the A1C treatment goal of less than 7.0 percent, which was a secondary endpoint of the study.

Commenting on the results, Peter Stein, M.D., vice president, late stage development, diabetes and endocrinology, Merck, said: “We are encouraged that these first Phase 3 studies of investigational ertugliflozin met their primary endpoints for ertugliflozin as a monotherapy and in combination with sitagliptin, and we look forward to progressing the VERTIS clinical development programme with Pfizer.”

“Pfizer has a legacy in CV disease, and after discovering ertugliflozin, wanted a partner that could help us meet our goal to improve disease management in patients with type 2 diabetes,” added James Rusnak, M.D., Ph.D., chief development officer, cardiovascular & metabolics, Pfizer Global Product Development. “Diabetes is a progressive disease, and many patients need multiple treatment options to manage their condition.”