Merck and Pfizer’s diabetes treatment meets primary endpoint in phase 3 trial

The drug was studied in patients with type 2 diabetes (T2D) in combination with sitagliptin and metformin.

The double-blind, placebo-controlled phase 3 VERTIS SITA2 trial randomized 463 subjects 1:1:1 to receive either 5 mg or 15 mg of ertugliflozin or placebo.

It met its primary endpoint, with patients on the 5 mg dose of the study drug achieving a 0.69% mean A1C reduction.

The patients on the 15 mg dose achieved a 0.76% mean A1C reduction.

Secondary endpoints met included the proportion of patients achieving the A1C treatment goal of less than 7.0%, placebo-adjusted mean reduction in body weight, placebo-adjusted mean reductions in fasting plasma glucose and placebo-adjusted mean reductions in systolic blood pressure.

The incidences of adverse events were same between the two doses of ertugliflozin and placebo, although a higher incidence of genital mycotic infections was observed in patients taking ertugliflozin 5 mg and ertugliflozin 15 mg.

Merck vice president, late stage development, diabetes and endocrinology Peter Stein 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.”

The companies plan to file new drug applications in the US by the end of the year for ertugliflozin and for two fixed dose combinations.

Additional regulatory submissions outside the US are planned to be made in 2017.

Image: Rigel's fostamatinib meets primary endpoint in phase 3 study in Chronic ITP. Photo: courtesy of jk1991 at FreeDigitalPhotos.net.