BioCentury
ARTICLE | Clinical News

Ertugliflozin: Phase III data

June 20, 2016 7:00 AM UTC

The double-blind, international Phase III VERTIS Mono trial in 461 Type II diabetics inadequately controlled on diet and exercise showed that once-daily 5 and 15 mg ertugliflozin each met the primary endpoint of reducing mean HbA1c from baseline to week 26 vs. placebo (0.8% and 1.04%, respectively, vs. 0.09%, p<0.001 for both). Low- and high-dose ertugliflozin also met the secondary endpoints of reducing mean FPG (placebo-adjusted reductions of 34.5 and 44 mg/dL, respectively, p<0.001 for both), body weight (placebo-adjusted reductions of 1.76 and 2.16 kg, respectively, p<0.001 for both) and postprandial glucose (placebo-adjusted reductions of 69 and 67.3 mg/dL, respectively, p<0.001 for both) from baseline to week 26 vs. placebo. Additionally, a significantly greater proportion of patients receiving low- and high-dose ertugliflozin achieved an HbA1c of <7% vs. placebo (28.2% and 35.8%, respectively, vs. 13.1%, p<0.001 for both). Data were presented at the American Diabetes Association meeting in New Orleans. ...