GI Dynamics has received conditional approval from FDA to begin a pivotal trial assessing its EndoBarrier in treating obese patients with uncontrolled type 2 diabetes. EndoBarrier is designed to line a portion of the intenstinal wall to affect the way the body responds to food. The randomized, double-blind, sham-controlled study is expected to enroll about 500 people at 25 U.S sites, measuring improvements in diabetes during a treatment period of up to 12 months. The primary endpoint is improvement in the blood marker hemoglobin A1C. GI Dynamics gained the conditional approval without conducting a U.S. pilot study. Based on the strength of data it has collected outside the U.S., EndoBarrier is commercially available in various European countries and in Chile.
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