Merck and Pfizer announced that VERTIS Mono and VERTIS Factorial, two Phase 3 studies evaluating the investigational oral SGLT-2 inhibitor, ertugliflozin, for the treatment of patients with type 2 diabetes, met their primary endpoints. Study results were presented for the first time at the 76th Scientific Sessions of the American Diabetes Association.
VERTIS Mono was a 26-week, randomized, double-blind, placebo-controlled study evaluating ertugliflozin as monotherapy in 461 patients with type 2 diabetes inadequately controlled on diet and exercise alone. Patients either received ertugliflozin 5mg, ertugliflozin 15mg, or placebo. VERTIS Factorial was another 26-week, randomized, double-blind study evaluating ertugliflozin in combination with Januvia (sitagliptin; Merck) in 1,233 patients with type 2 diabetes inadequately controlled on metformin alone (≥1500 mg/day). Patients either received ertugliflozin 5mg with sitagliptin 100mg, ertugliflozin 15mg with sitagliptin 100mg, ertugliflozin 5mg, ertugliflozin 15mg, or sitagliptin 100mg. The primary endpoint for both studies was the reduction in A1C, with a secondary endpoint of achieving an A1C treatment goal of less than 7%.
Findings from VERTIS Mono showed that patients treated with ertugliflozin 5mg and 15mg had a significantly greater A1C reductions of 0.99% and 1.16%, respectively, compared to placebo (P<0.001 for both). Additionally, significantly more patients treated with ertugliflozin achieved the A1C treatment goal of less than 7%, with 28.2% in the 5mg arm and 35.8% in the 15mg arm vs. 13.1% in the placebo arm (P<0.001 for both).
Patients receiving either doses of ertugliflozin in combination with sitagliptin in VERTIS Factorial achieved greater reductions in A1C compared to patients receiving ertugliflozin or sitagliptin alone. An A1C reduction of 1.5% was observed for both ertugliflozin/sitagliptin dose combinations, as compared to 1% for ertugliflozin 5mg alone, 1.1% for ertugliflozin 15mg alone, and 1.1% for sitagliptin 100mg alone (P<0.001 for both combinations vs. individual treatments). Additionally, significantly more patients in the ertugliflozin/sitagliptin combination group achieved the A1C treatment goal of less than 7% (52.3% for 5mg and 49.2% for 15mg), as compared to ertugliflozin 5mg or 15mg alone and sitagliptin 100mg alone (26.4%, 31.9%, 32.8%, respectively; P<0.001 for both combinations vs. individual treatments).
Overall adverse event rates for both studies were comparable across all therapeutic groups.
Merck and Pfizer plan to submit New Drug Applications to the Food and Drug Administration for ertugliflozin and the two fixed-dose combination tablets (ertugliflozin plus Januvia, and ertugliflozin plus metformin) by the end of 2016.