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ARTICLE | Clinical News

ITCA 650: Additional Phase III data

June 15, 2015 7:00 AM UTC

Additional data from the double-blind, U.S. Phase III FREEDOM-1 trial in 460 Type II diabetics with an HbA1c of 7.5-10% not controlled on 0-3 oral diabetes drugs showed that once-daily ITCA 650 reduced mean HbA1c from baseline to week 39, the primary endpoint, by 1.4% in the modified intent-to-treat (mITT) population, which included all patients with a post-baseline HbA1c measurement. In pre-specified patient populations, ITCA 650 reduced mean HbA1c by 1.7% in patients primarily on background metformin or diet and exercise and by 1.2% in patients on a sulfonylurea-based background regimen. Furthermore, patients who received 60 Ug ITCA 650 achieved a significant mean weight loss of 4 kg at week 39 vs. 2 kg for placebo. Patients received once-daily 40 or 60 Ug ITCA 650 or placebo. Data were presented at the American Diabetes Association meeting in Boston. ...