Ertugliflozin: Phase III data

The double-blind, placebo-controlled Phase III VERTIS Factorial trial in 1,233 Type II diabetics inadequately controlled on metformin alone showed that once-daily 5 and 15 mg ertugliflozin plus 100 mg Januvia sitagliptin each met the primary endpoint of reducing mean HbA1c from baseline to week 26 vs. Januvia alone, low-dose ertugliflozin alone and high-dose ertugliflozin alone (1.5% for both vs. 1.1%, 1% and 1.1%, respectively, p<0.001 for all). Low- and high-dose ertugliflozin plus Januvia also met the secondary endpoints of reducing FPG from baseline to week 26 (44 and 48.7 mg/dL, respectively, vs. 25.6, 35.7 and 36.9 mg/dL, respectively, p<=0.004 for all) and of a greater proportion of patients achieving an HbA1c of <7% (52.3% and 49.2%, respectively, vs. 32.8%, 26.4% and 31.9%, respectively, p<0.001 for all) vs. Januvia alone, low-dose ertugliflozin alone and high-dose ertugliflozin alone. Low- and high-dose ertugliflozin plus Januvia also met the secondary endpoint of reducing body weight vs. Januvia alone (2.5 and 2.9 kg, respectively, vs. 0.7 kg, p<0.001 for both). Data were presented at the American Diabetes Association meeting in New Orleans. ...