GI Dynamics (ASX:GID) today released results from a meta-analysis of its EndoBarrier device exploring its use in helping patients with type 2 diabetes and obesity, touting improvements in insulin resistance and positive changes in weight.
The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract to treat Type II diabetes and obesity, the Lexington, Mass.-based company said.
Results from the analysis were published in the journal Diabetes Care.
In the analysis, researchers examined data from 17 published studies evaluating the EndoBarrier, with a primary outcome of changes in HbA1c and homeostatic model assessment of insulin resistant. Secondary outcomes were change in weight and change in hormones that are critical to the regulation of metabolic and bariatric disorders.
Results indicated a 1.3% reduction in HbA1c with use of the EndoBarrier, a 0.9% absolute reduction over control-arm patients in the studies being analyzed. At six months post-removal, HbA1c changes were reported at 0.9% with use of the EndoBarrier, while improvements in HOMA-IR were noted at 4.6, the company said.
Average weight loss reductions across the studies were noted at 11.3 kilograms, a decrease in 18.9% of total weight lost, or 36.9% of excess weight, according to the study. At 12 months out, total weight loss in the analysis was reported at 7.2% for patients who used the EndoBarrier.
“The analysis shows that DJBL is effective at treating diabetes in this patient population with a reduction in HbA1c of 1.3%, and with many patients coming off diabetic medication. This reduction in HbA1c is significantly better by 0.9% as compared to optimal medical management alone. In addition, this study demonstrates that patients who receive DJBL experience significant improvements in insulin resistance and weight loss, which persist up to at least six months after device removal. Given a rising pandemic of obesity and diabetes, DJBL may offer a highly effective treatment option for this patient population,” study author Dr. Pichamol Jirapinyo of Boston’s Brigham and Women’s Hospital said in prepared remarks.
“We are pleased to review the results from this comprehensive EndoBarrier meta-analysis that Dr. Jirapinyo and the clinical team at Harvard Medical School and Brigham and Women’s Hospital conducted. The results confirm that EndoBarrier produces a significant reduction in HbA1c and weight, significantly reduces insulin resistance and creates a hormonal effect similar in many respects to gastric bypass. This data clearly shows a very favorable treatment effect with significant treatment durability and a positive benefit-risk profile. This study presents the most comprehensive EndoBarrier meta-analysis we have seen and this type of data is indicative of EndoBarrier’s highly impactful clinical utility,” prez & CEO Scott Schorer said in a press release.
Earlier this week, GI Dynamics announced it inked a binding commitment for a $1.8 million financing deal with Crystal Amber Fund Limited.