Two phase 3 clinical trials evaluating ertugliflozin for the treatment of type 2 diabetes met their primary endpoints demonstrating statistically significant reductions in blood glucose (A1C).
Merck and Pfizer are co-developing and co-commercializing ertugliflozin under their global collaboration agreement, signed in April 2013.
Patients treated with either of two doses, 5 mg or 15mg, of ertugliflozin as monotherapy in Vertis Mono study experienced reductions in A1C of 0.99% and 1.16%, respectively, greater than placebo (p<0.001).
In addition, several patients in the treatment group achieved the A1C treatment goal of A1C less than 7% compared with placebo (13.1%) (p<0.001, for both comparisons).
Vertis Factorial, evaluating the co-administration of ertugliflozin and Januvia (sitagliptin), demonstrated that the two drugs taken together were more effective than either alone.
The A1C reduction in the co-administration group (either 5 mg or 15 mg of ertugliflozin with 100 mg of sitagliptin) was 1.5% compared to 1% for 5 mg of ertugliflozin alone, 1.1% for 15 mg of ertugliflozin alone and 1.1% for sitagliptin alone (p<0.001).
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%, which was a secondary endpoint of the study.
Another Phase 3 study, Vertis CV, evaluating ertugliflozin’s effect on enhancing CV outcomes in type 2 diabetics is ongoing.
Merck and Pfizer plan to submit new drug applications to the US Food and Drug Administration for ertugliflozin and the two fixed-dose combination tablets (ertugliflozin plus Januvia, and ertugliflozin plus metformin) by the end of this year.
Vertis Mono and Vertis Factorial are a part of the Vertis clinical development program, which includes a total of nine Phase 3 trials in about 12,600 adults with type 2 diabetes.
Published 13 June 2016