In Phase III study (VERTIS SITA2) ertugliflozin meets endpoints in treatment of type 2 diabetes. - Merck Inc., + Pfizer Inc.,

Merck Inc., in partnership with Pfizer Inc. announced that a Phase III study (VERTIS SITA2) 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 of 0.69 percent and 0.76 percent, respectively, compared with placebo (p<0.001, for both comparisons when added to patients on a background of sitagliptin 100 mg day and stable metformin more than or equal to 1500 mg day. these study results were presented for the first time during an oral session at the 52nd annual meeting of the european association for the study of diabetes easd in munich germany.>

In this double-blind, randomized, placebo-controlled study, 463 patients with type 2 diabetes and a baseline A1C of 7.0 � 10.5 percent were randomized to receive ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo in a 1:1:1 ratio. In addition to meeting the primary endpoint of reducing A1C at 26 weeks, ertugliflozin also met the following key secondary endpoints in the study:- A greater proportion of patients taking ertugliflozin 5 mg and 15 mg achieved the A1C treatment goal of less than 7.0 percent (32.1 percent and 39.9 percent, respectively) compared with the placebo group (17.0 percent) (p<0.001, for both comparisons based on adjusted odds ratios - placebo-adjusted mean reduction in body weight of 4.4 lbs 2.0 kg for the 5 mg dose and 3.7 lbs 1.7 kg for the 15 mg dose p><0.001, for both comparisons- placebo-adjusted mean reductions in fasting plasma glucose fpg of 25.1 mg dl 1.4 mmol l for the 5 mg dose and 31.3 mg dl 1.7 mmol l for the 15 mg dose p><0.001, for both comparisons .>

Overall adverse event (AE) rates were generally similar between ertugliflozin 5 mg (41.7 percent), ertugliflozin 15 mg (43.8 percent) and placebo (48.4 percent), with a similar rate of one or more serious AEs across all groups (4.5 percent for ertugliflozin 5 mg; 2.0 percent for ertugliflozin 15 mg; 3.3 percent for placebo).Placebo-adjusted mean reductions in systolic blood pressure of 2.9 mmHg (5 mg, p=0.019) and 3.9 mmHg (15 mg, p=0.002).

Comment: Merck Inc., and Pfizer Inc., plan to submit New Drug Applications to the FDA for ertugliflozin and two fixed-dose combinations (ertugliflozin plus Januvia (sitagliptin) and ertugliflozin plus metformin) by the end of 2016, with additional regulatory submissions outside of the U.S. to follow in 2017.