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ARTICLE | Clinical News

Ertugliflozin: Phase III data

September 26, 2016 7:00 AM UTC

Top-line data from the double-blind, international Phase III VERTIS SITA2 trial in 463 Type II diabetics inadequately controlled on Januvia sitagliptin and metformin showed that once-daily 5 and 15 mg oral ertugliflozin plus Januvia and metformin each met the primary endpoint of reducing mean HbA1c from baseline to week 26 vs. placebo plus Januvia and metformin (0.8% and 0.9%, respectively, vs. 0.1%, p<0.001 for both). Low- and high-dose ertugliflozin plus Januvia and metformin also met the secondary endpoints of a greater proportion of patients achieving an HbA1c of <7% at week 26 vs. placebo plus Januvia and metformin (32.1% and 39.9%, respectively, vs. 17%, p<0.001 for both) and of reducing mean body weight (3.3 and 3 kg, respectively, vs. 1.3 kg, p<0.001 for both), mean FPG (1.5 and 1.8 mmol/L, respectively, vs. 0.1 mmol/L, p<0.001 for both) and mean SBP (3.8 and 4.8 mmHg, respectively, vs. 0.9 mmHg, p=0.019 and p=0.002) from baseline to week 26 vs. placebo plus Januvia and metformin. Data were presented at the European Association for the Study of Diabetes meeting in Munich. ...