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Clinical update

EndoBarrier: update on ENDO Trial

Currently 17 centres are enrolling patients

The ENDO Trial, a multi-centre, pivotal clinical trial of EndoBarrier (GI Dynamics) for the treatment of patients who have uncontrolled type 2 diabetes and obesity, has now 17 sites actively enrolling study subjects. The trial will enrol approximately 500 patients at up to 25 sites across the US.

“The ENDO Trial is currently enrolling patients at more than half of the planned trial sites,” said Dr David Maggs, chief medical officer, GI Dynamics, Inc. “We believe EndoBarrier offers a paradigm shift in offering metabolic control solutions for patients with type 2 diabetes and we are very pleased with the interest and support we have received from the clinical site teams to date.”

Eligible patients should be between the ages of 21 and 65, have a BMI 30-50, have uncontrolled type 2 diabetes and currently use metformin, a sulfonylurea, or a combination of both, but are unable to achieve adequate glycaemic control.

The ENDO Trial is a randomised, double-blind, sham controlled trial, 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; secondary measures include weight loss and improvement in select cardiovascular risk factors, such as cholesterol.

Active sites currently enrolling patients for the ENDO Trial include:

  • 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)

GI Dynamics will pursue regulatory approval of EndoBarrier in the US, following the successful completion of the ENDO Trial.

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