EndoBarrier® Therapy Improves Blood Sugar Levels And Weight Loss In Type 2 Diabetics

“The results from this study demonstrate that EndoBarrier Therapy is a well-tolerated and effective treatment for type 2 diabetes, resulting in significant improvements in blood sugar levels and weight loss in patients with type 2 diabetes”

In short

Endobarrier®, from GI Dynamics, Inc. is a non-surgically inserted device for treating type 2 diabetes and obesity. The company has announced that data from a previously reported multi-centre, randomised, controlled trial evaluating EndoBarrier® Therapy in obese patients with type 2 diabetes suggested that at six months, there was statistically significant better weight loss and statistically significant improvement in HbA1c levels in patients treated with EndoBarrier compared to the diet-controlled group.

Background

EndoBarrier device is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. EndoBarrier Therapy affects certain gastrointestinal hormones involved in insulin sensitivity, glucose metabolism and satiety, and these changes allow for rapid and sustained improvement of type 2 diabetes and weight loss.

The study

The following study results were highlighted on Saturday, June 9, 2012, at the American Diabetes Association’s (ADA) 72nd Scientific Sessions in Philadelphia. The results of the study were presented in a peer-reviewed forum for the first time at the ADA meeting during a poster presentation titled, “Six month results of a multi-centre, prospective, randomised trial of the endoscopic Duodenal-Jejunal Bypass Liner for the treatment of type 2 diabetes in obese subjects.”

In the study, 34 obese subjects with type 2 diabetes (T2D) were implanted with EndoBarrier for six months with six months of follow-up. There were 39 patients in the diet control group, and both groups were comparable with respect to age, gender, BMI (mean 35.7 vs. 37.1), duration of T2D (5.2 vs. 5.3 years), HbA1c levels (8.4 vs. 8.3) and T2D treatment. At six months, there was statistically significant better weight loss and statistically significant improvement in HbA1c levels in patients treated with EndoBarrier compared to the diet-controlled group. Specifically, the study found that:

EndoBarrier patients had an average 1.3% decrease in HbA1c at six months compared to 0.6% for the control group (p=0.02)

EndoBarrier patients had an average total body weight loss of 9.3% over the six month period compared to 5.7% body weight loss for the control group (p=0.005)

Clinician comments

“The results from this study demonstrate that EndoBarrier Therapy is a well-tolerated and effective treatment for type 2 diabetes, resulting in significant improvements in blood sugar levels and weight loss in patients with type 2 diabetes,” said Dr. Koehestanie. “Importantly, while EndoBarrier is approved for up to 12 months of use, these data highlight the clinical benefits that patients can experience as early as six months following implant.”

Company comments

“Globally, more than 63 million people are currently battling the dual challenge of managing type 2 diabetes and obesity,” said Stuart A. Randle, president and chief executive officer of GI Dynamics. “These data provide further validation for the benefits of EndoBarrier Therapy on both blood sugar and weight loss in our target patient population of people living with type 2 diabetes who are obese. We were thrilled to have the opportunity to showcase the results of this study in a prestigious, peer-reviewed forum such as the ADA’s 72nd Scientific Sessions.”

Regulatory status

EndoBarrier received CE Mark approval for Europe in 2010 as well as approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity. EndoBarrier is currently commercially available in select European markets, Chile and Australia.

Source: GI Dynamics Inc