GI Dynamics EndoBarrier Meets Diabetes and Obesity Study Endpoints

GI Dynamics today announced the results of a study of its EndoBarrier System that met parameters for efficacy and safety.

Boston-based GI Dynamics designed its EndoBarrier endoscopic device therapy as a non-surgical alternative treatment for type 2 diabetes and obesity for patients who do not have adequate control of their condition through their medications and to their current way of life.

According to a press release, the study data was presented at the annual Digestive Disease Week (DDW) conference last month. The results of the multicenter, randomized, simulation-controlled trial of a duodenal jejunal bypass liner (DJBL) for the treatment of type 2 diabetes mellitus were presented by Dr. Christopher C. Thompson, Professor, Harvard Medical School and director of endoscopy at Brigham and Women’s Hospital.

The study recruited patients from 2013 to 2015 and included subjects randomized to DJBL and a sham procedure with a moderate-intensity lifestyle intervention. Primary endpoints included safety, defined as an incidence of early device removal due to a serious adverse event (SAE) of ≤ 15%, and efficacy of glycemic control as demonstrated by the mean change in HbA1c at 12 months with a margin of superiority of ≥ 0.4% HbA1c over false.

The analysis demonstrated that the EndoBarrier met both overall glycemic control efficacy and safety parameters related to SAE device removal, while providing clinically meaningful weight loss and improvement in comorbidity.

GI Dynamics had terminated the ENDO trial in 2015 before completing enrollment due to a higher than expected incidence of liver abscess. The company initiated a new US FDA Investigational Device Exemption Study (STEP-1) in 2019 to study EndoBarrier. It is currently recruiting patients at five sites in the United States

“Insulin therapy is associated with poor long-term outcomes in patients with type 2 diabetes mellitus and obesity, and bariatric surgery is effective for glycemic control but has a higher risk than medical therapy. EndoBarrier is a less invasive, intermediate alternative for this struggling population,” Thompson said in the release. “This new approach shows promise and has the potential to offer patients and clinicians another safe and effective treatment option.”

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