Study supports use of EndoBarrier Therapy for patients with type 2 diabetes and obesity

Dec 3 2013

Accumulated Clinical Experience across Four International Studies Highlighted in Two Presentations at World IDF Congress

GI Dynamics, Inc. (ASX: GID) today announced findings from a new meta-analysis which describes the increasingly robust efficacy and safety profile of EndoBarrier^® Therapy, an endoscopically-delivered device therapy approved for the treatment of type 2 diabetes and obesity. The findings, which were presented today at the International Diabetes Federation’s World Diabetes Congress in Melbourne, Australia, add to the growing body of clinical evidence supporting the use of EndoBarrier Therapy for patients with type 2 diabetes and obesity. 

“The progressive nature of type 2 diabetes and obesity poses a significant and growing challenge in clinical practice, and current therapies often do not provide optimal solutions for many patients,” said David Maggs, chief medical officer of GI Dynamics, and lead author of the study. “Medical devices such as EndoBarrier represent an exciting class of therapy that can help bridge the gap between pharmaceuticals, which may become less effective over time, and bariatric surgery, which can be effective, however, requires irreversible anatomical changes. These new meta-analysis data further support the strong safety profile and robust efficacy of EndoBarrier Therapy in the management of type 2 diabetes and obesity.” 

In an oral presentation titled, “Endoscopic, Duodenal-Jejunal Bypass Liner Exerts Robust Metabolic Effects: Accumulating Clinical Experience Across Four Studies,” results from four prospective, single-arm studies were shared involving a total of 130 patients from three countries implanted with EndoBarrier for a planned 12-month duration. Across all studies, the metabolic effects of EndoBarrier Therapy were robust and well established early in the treatment period. Key findings include:

• Among patients with type 2 diabetes, EndoBarrier Therapy demonstrated a significant reduction in HbA1c of -1.3 ± 0.19% from baseline, with more than half (52%) of diabetic patients achieving healthy blood glucose levels (HbA1C ≤ 7%) during the treatment period

• Patients across all studies (n=129) experienced total body weight loss of 14.2 ± 0.8kg from baseline

• Adverse events (AEs) were mostly gastrointestinal in nature and mild or moderate in severity

• Mean treatment duration for all patients with data available (n=126) was 10.2 months

Additionally, findings from three of the four prospective, single-arm studies involving a total of 87 obese patients with type 2 diabetes were highlighted in a poster titled “Robust Metabolic Improvement Observed with the Endoscopic, Duodenal-Jejunal Bypass Liner: 12 Month Data in Obese Type 2 Diabetes.” The poster features improvements in glycemia and weight. 

Stuart A. Randle, president and CEO of GI Dynamics, commented, “We are pleased to report these data during the IDF World Congress this week and share the measurable impact we are seeing EndoBarrier Therapy have on HbA1c levels, weight loss and key cardiovascular risk factors. Diabetes and obesity remain two of the largest health concerns around the globe, and despite available pharmaceutical and surgical options, these conditions remain inadequately treated and controlled in many patients. EndoBarrier Therapy is uniquely positioned to help these people who are living with uncontrolled type 2 diabetes and obesity.”

More than 1,200 patients worldwide have been treated with EndoBarrier Therapy, the first endoscopically-delivered device therapy for patients with type 2 diabetes and obesity. It currently is approved for commercial use in Europe and Australia, as well as by a growing number of countries in South America and the Middle East.