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ARTICLE | Clinical News

ITCA 650: Interim Phase III data

June 23, 2014 7:00 AM UTC

Interim data from the open-label, U.S. Phase III FREEDOM 1 HBL trial in 60 Type II diabetics with an HbA1c of >10% to <=12% that is not controlled on 0-3 oral diabetes drugs showed that ITCA 650 led to mean reductions from baseline in HbA1c of 2.5% at week 13 (n=50), 2.9% at week 19 (n=39) and 3.2% at week 26 (n=25). In patients who completed >=13 weeks of treatment, 78% achieved a reduction in HbA1c of >=2%, 50% achieved a reduction in HbA1c of >3% and 22% achieved a reduction in HbA1c of >=4%, with 26% of patients achieving an HbA1c of <7%. Mean weight loss at week 26 was 1.1 kg. ITCA 650 was generally well tolerated. Patients receive once-daily 20 µg ITCA 650 for the first 3 months followed by once-daily 60 µg ITCA 650 for 6 months. Data were presented at the American Diabetes Association meeting in San Francisco. Additional data will be presented at the European Association for the Study of Diabetes meeting in Vienna in September. ...