Intarcia Enrolls First Patients in "FREEDOM" Global Phase 3 Program for ITCA 650 in Type ... ( BOSTON March 21 2013 /- a hr (P...)

Intarcia Enrolls First Patients in "FREEDOM" Global Phase 3 Program for ITCA 650 in Type 2 Diabetes

Date:3/21/2013

BOSTON, March 21, 2013 /PRNewswire/ -- Intarcia Therapeutics, Inc. announced today the enrollment of the first patients in FREEDOM-1, the first of four planned Phase 3 clinical trials studying the safety and efficacy of ITCA 650 (continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes (T2D). Intarcia is conducting the FREEDOM clinical program with strategic partner Quintiles, Inc., the world's leading clinical research organization, who will be responsible for the global implementation of all four trials. This collaboration, along with strategic input from a world-class group of renowned diabetes experts, is designed to achieve the highest standards of quality, safety and operational excellence.

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The FREEDOM clinical trial program aims to demonstrate that optimizing GLP-1 therapy with once- or twice-yearly dosing of ITCA 650 results in effective, well tolerated glycemic control that virtually ensures longer-term compliance – a transformational approach to controlling T2D that aims to free patients from the frequent self-injections that all too often result in poor therapeutic compliance and control. The FREEDOM-1 study is a placebo-controlled, double-blind study involving T2D patients whose HbA1c is not controlled on zero to three oral anti-diabetes drugs and whose HbA1c measures between 7.5% and 10.0%. The 450 patients will be randomized into three groups in a 1:1:1 ratio, evaluating ITCA 650 40 mcg/d and ITCA 650 60 mcg/d versus placebo. Subjects in the active arms will be treated with 3-month devices for the first 13 weeks that deliver an initial dose of 20 mcg/d, and then treated with 6-month ITCA 650 at doses of 40 or 60 mcg/d. The primary endpoint will be change in HbA1c at 9
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