Massachusetts-based GI Dynamics, Inc. says it is currently enrolling subjects at 17 sites across the United States for its clinical trial of the EndoBarrier for people who have uncontrolled type 2 diabetes and are obese. The company expects to enroll approximately 500 people who meet the enrollment criteria at up to 25 sites in the United States.
EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. GI Dynamics has conducted 12 clinical studies of its product outside the United States and one within. It currently is pursuing U.S. regulatory approval, and the 500-prson EndoBarrier trial is one of the benchmarks it must meet.
The trial is designed to assess improvements in diabetes over a treatment period of up to 12 months. The primary endpoint of the trial is improvement in HbA1c (a key blood sugar measure for diabetes); secondary measures include weight loss and improvement in select cardiovascular risk factors, such as cholesterol.
Eligible patients who would like to enroll in the trial should be between the ages of 21 and 65, have a body mass index between 30 and 50, have uncontrolled type 2 diabetes and currently use metformin, a sulfonylurea, or a combination of both, but are unable to achieve adequate glycemic control. They can find more information about the ENDO Trial by calling 1-888-9STUDY9 (1-888-978-8399) or by visiting www.endobarriertrial.com
The ENDO Trial eventually will enroll approximately 500 patients at up to 25 sites across the United States. The 17 sites listed below are actively enrolling study subjects. More sites are being added and patients are needed.
• Beth Israel Medical Center (New York City)
• Billings Clinic (Billings, Mont.)
• Boston Medical Center (Boston)
• Emory University (Atlanta)
• Legacy Research Institute (Portland, Ore.)
• Massachusetts General Hospital (Boston)
• MedStar Health Research Institute (Hyattsville, Md.)
• Northwestern University (Chicago)
• Tulane University Health Science Center (New Orleans)
• University of Alabama at Birmingham (Birmingham, Ala.)
• University of Colorado/Anschutz Health & Wellness Center (Aurora, Colo.)
• UMass Memorial Medical Center (Worcester, Mass.)
• University of Michigan (Ann Arbor, Mich.)
• University of North Carolina (Chapel Hill, N.C.)
• UT Southwestern Medical Center (Dallas)
• Washington University (St. Louis, Mo.)
• Weill Cornell Medical Center (New York City)