GI Dynamics Initiates U.S. Pivotal Clinical Trial of EndoBarrier®
Published: Jan 15, 2013
LEXINGTON, Mass. & SYDNEY--(BUSINESS WIRE)--GI Dynamics, Inc. (ASX: GID) today announced that it has initiated its U.S. multicenter pivotal clinical trial of EndoBarrier®, the ENDO Trial, for the treatment of patients who have uncontrolled type 2 diabetes and are obese. EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. In previous clinical studies, EndoBarrier has been shown to achieve rapid reductions in blood sugar levels and weight loss of approximately 20 percent in 12 months.1, 2 EndoBarrier received CE Mark approval in 2010, and approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity for up to 12 months.