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EndoBarrier trial

ENDO Trial gets underway in the US

Study will enrol 500 patients at 25 US centres

The multi-centre pivotal clinical trial of the EndoBarrier (GI Dynamics), the ENDO Trial, has started in the US. The study, which was approved by the FDA in October 2012, will investigate the device’s efficacy in treating obese patients who have uncontrolled type 2 diabetes.

The ENDO trial is a randomised, double-blind, sham-controlled trial, which will enrol approximately 500 people with uncontrolled diabetes at 25 sites in the US. The trial is designed to assess improvements in patients’ diabetes during a study period of up to 12 months.

“We’re excited to initiate this important trial in the US,” said Dr Lee M Kaplan, lead investigator and director of the Obesity, Metabolism & Nutrition Institute at the Massachusetts General Hospital and Harvard Medical School. “Results from the pilot studies of EndoBarrier have been very promising, and we look forward to determining the efficacy and safety of this device in this large, controlled, pivotal trial.”

The primary endpoint for the trial is an improvement in patients’ HbA1c levels. Secondary endpoints include weight loss and improvements in some cardiovascular risk factors.

“The start of our US pivotal trial marks a major milestone on the road to bringing EndoBarrier to the millions of people in this country living with type 2 diabetes,” said Stuart A. Randle, president and chief executive officer, GI Dynamics. “We appreciate the support of our investigators and clinical trial sites as we begin the process of enrolling patients and executing this landmark clinical trial.”

The trial is an important step in the company’s bid to secure marketing approval for the EndoBarrier in the US. Data gathered during the trial will be used to support a premarket application for the device. If this is approved, GI Dynamics will be able to market the device in the US.

Implanted endoscopically, the EndoBarrier is designed to line the walls of a portion of the intestine.

The device has already been approved for marketing in Australia and the EU.

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