The FDA has given conditional approval to GI Dynamics to proceed with a pivotal clinical trial of the company’s EndoBarrier Therapy, a new type of treatment for patients with uncontrolled type 2 diabetes and obesity that does not involve medications or surgery.
EndoBarrier is a thin, flexible, tube-shaped liner that acts as a physical barrier between food and the intestine wall. The product alters the digestion process, resulting in improved glucose control and significant weight loss during the implant period.
Numerous studies conducted outside of the United States have shown the EndoBarrier to be a safe and effective treatment option. It is currently approved and commercially available in select regions in Europe, South America and Australia.
About EndoBarrier Therapy
The EndoBarrier medical device is placed endoscopically (through the mouth) into the top portion of the small intestine. The procedure usually takes less than 30 minutes and does not involve incisions or scars. Patients can go home immediately after placement.
The treatment mimics the effects of gastric bypass surgery, without the associated risks. It helps patients improve glucose levels and lose weight by affecting certain gastrointestinal hormones involved in insulin sensitivity, glucose metabolism, and satiety.
The EndoBarrier may be implanted for up to 12 months of use and has shown benefits in 3-month, 6-month, and 12-month studies. The device is easily removed after the treatment period during a quick and simple endoscopic, outpatient procedure.
About the Clinical Trial
The EndoBarrier pivotal trial is a randomized, multi-center, double-blind, sham controlled trial that is expected to enroll approximately 500 people living with uncontrolled diabetes and obesity who meet the enrollment criteria at 25 sites in the United States.
The clinical trial is designed to assess the 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. The secondary measures include weight loss and improvements in select cardiovascular risk factors, such as cholesterol.
The US clinical trial will be overseen by Committee Chair Lee Kaplan, M.D., Ph.D., Massachusetts General Hospital; Louis Aronne, M.D., New York Presbyterian Hospital, Weill Cornell Medical Center; John Buse, M.D., Ph.D., University of North Carolina at Chapel Hill; and Steven Edmundowicz, M.D., F.A.S.G.E., Washington University in St. Louis. All were chosen by GI Dynamics for their leadership in metabolic disease and endoscopic techniques.
Although details of the study have yet to be finalized, the company hopes to begin the trial before the end of the year. Physicians or patients interested in learning more about the EndoBarrier clinical trial may call (781) 357-3252.
Source: GI Dynamics Press Release, August 23, 2012