Phase III trials of MK 8835 (ertugliflozin) meet primary endpoint in type 2 diabetes- Merck Inc and Pfizer

Merck Inc and Pfizer announced that two Phase III studies (VERTIS MET and VERTIS SITA) of MK 8835 (ertugliflozin), to help improve glycemic control in adults with type 2 diabetes, met their primary endpoints. In the studies, both doses of ertugliflozin tested (5 mg and 15 mg daily) achieved statistically significant reductions in A1C, a measure of average blood glucose over a two- to three-month timeframe, when added to metformin or in initial co-administration with sitagliptin.

VERTIS MET, a 26-week study showed patients taking ertugliflozin 5 mg or 15 mg and metformin experienced greater reductions in A1C compared to placebo (0.7 percent and 0.9 percent, respectively, compared with 0.0 percent for placebo). Ertugliflozin in combination with metformin also met a secondary endpoint in the study, as significantly more patients taking either ertugliflozin 5 mg or 15 mg achieved the ADA�s recommended A1C treatment goal of less than 7.0 percent compared with placebo and metformin. As add-on therapy to metformin, treatment with ertugliflozin also resulted in significant reductions in fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP) and diastolic blood pressure (DBP), compared with placebo. The 26-week VERTIS SITA study showed patients taking ertugliflozin 5 mg or 15 mg, in combination with sitagliptin 100 mg, experienced greater reductions in A1C compared with patients taking placebo alone (1.6 percent and 1.7 percent, respectively, compared with 0.4 percent in patients taking placebo).

Additionally, the co-administration of ertugliflozin and sitagliptin met a secondary endpoint in the study, as significantly more patients taking ertugliflozin 5 mg or 15 mg, in combination with sitagliptin 100 mg, achieved the A1C treatment goal of less than 7.0 percent. Treatment with the initial combination of ertugliflozin and sitagliptin also resulted in significant reductions in FPG, body weight and SBP, compared with placebo.

Ertugliflozin is being investigated in the VERTIS clinical development program, which is comprised of nine Phase III trials in approximately 12,600 adults with type 2 diabetes. The results, along with 52-week extension data from three other studies in the VERTIS clinical development program of ertugliflozin, will be presented at the 77th Scientific Sessions of the American Diabetes Association.