Ertugliflozin meets in Phase III diabetes studies

Merck & Co. Inc. (NYSE:MRK) and Pfizer Inc. (NYSE:PFE) said diabetes candidate ertugliflozin ( PF-4971729, MK-8835) met the primary endpoints in two Phase III studies. The partners plan to submit an NDA for the oral sodium-glucose cotransporter 2 ( SGLT2) inhibitor by YE16, and have expanded an ongoing cardiovascular outcomes study of the candidate.

In the 461-patient VERTIS Mono study, 5 and 15 mg ertugliflozin once daily as monotherapy significantly lowered HbA1c at week 26 vs. placebo, the primary endpoint (p<0.001). Significantly more patients receiving ertugliflozin achieved HbA1c levels below 7%, a secondary endpoint, vs. placebo (28.2% for the low dose and 35.8% for the high dose vs. 13.1% for placebo, p<0.001). ...