Phase 3 Results for Ertugliflozin Are Published, With FDA Action Pending

Results for an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor that were presented in June at the American Diabetes Association (ADA) Scientific Sessions were published today, while the drug’s sponsors await FDA decisions that are scheduled to come in December.

Phase 3 results published today for VERTIS MET, the combination of ertugliflozin and metformin, show that the fixed-dose combination produces better glycemic control, reduced blood pressure, and more weight loss than placebo, along with an increase in genital mycotic infections that is consistent with drugs in the SGLT2 inhibitor class.

The findings were published in the journal Diabetes, Obesity and Metabolism.

Ertugliflozin, under development by Merck and Pfizer, has applications pending as a monotherapy and in fixed-dose combinations with metformin and sitagliptin, which officials announced in March. The combination with sitagliptin, the dipeptidyl peptidase-4 inhibitor sold as Januvia, has most intrigued market-watchers given that drug’s popularity with physicians.

The VERTIS MET results found that patients taking either the 5 mg or the 15 mg dose, with metformin, experienced greater reductions in glycated hemoglobin (A1C) than those taking placebo. The average A1C reductions were 0.7% and 0.9%, respectively. From a baseline of 8.1%, patients’ average A1C fell to 7.3% with the 5 mg dose and to 7.2% with the 15 mg dose, compared with a mean change of 0.0% for patients taking placebo. Patients taking the study medication were more likely to achieve the ADA recommended A1C target of 7%.

Reference

Rosenstock J, Frias J, Pall D, et al. Effect of ertugliflozin on glucose control, body weight, blood pressure and bone density in type 2 diabetes mellitus inadequately controlled on metformin monotherapy (VERTIS MET) [published online September 7, 2017] . Diabets Obes Metab. 2017; DOI: 10.1111/dom.13103.