Oral and poster presentations at American Diabetes Association annual meeting reinforce value of duodenal-jejunal exclusion for treating type 2 diabetes and obesity

LEXINGTON, Mass. & SYDNEY–(BUSINESS WIRE)–GI Dynamics, Inc. (ASX: GID), a medical device company, provides innovative treatments for type 2 diabetes and obesity, today announced new data showing the effect of EndoBarrier® Therapy on bile acid regulators and other anthropometric, biochemical and hormonal parameters. Professor Martin Haluzik of the IKEM Research Centre Prague, Czech Republic, presented these findings during an oral session at the 75th Annual Meeting of the American Diabetes Association in Boston, Massachusetts.

Prof. Haluzik’s presentation, titled ‘Ten Months of Treatment with Endoscopic Duodenal-jejunal Bypass Liner Reduces Glycemic Variability, Increases Serum Fibroblast Growth Factor 19 (FGF-19), and Partially Restores the Incretin Effect in Obese Subjects with Type 2 Diabetes Mellitus,’ follows the progress of 30 obese patients with type 2 diabetes after being implanted with the EndoBarrier gastrointestinal liner.

Study results show that EndoBarrier Therapy led to an improvement in multiple glycemic parameters and a sustained decrease in body weight and body fat. Notably, fibroblast growth factor 19 (FGF-19), a potent regulator of bile acid, glucose and fat metabolism, was markedly increased by EndoBarrier Therapy. In addition, EndoBarrier Therapy also raised levels of the incretin hormone GLP-1.

“The positive effects of EndoBarrier Therapy on glycemia, body weight and body fat are well documented. However, this data shows that EndoBarrier Therapy also elevates FGF-19 levels – a naturally occurring protein that is thought to be involved in bile acid synthesis and more general metabolic homeostasis. More specifically, FGF-19 is active in a specific metabolic axis that has drawn recent attention as a putative pharmacological target for the treatment of fatty liver disease,” commented David Maggs, MD, chief medical officer of GI Dynamics.

Other posters pertaining to EndoBarrier Therapy presented at this year’s ADA meeting included the following:

Weight Loss-independent Improvement in Type 2 Diabetes with EndoBarrier Therapy

L. Kaplan, et al, Boston, MA

The metabolic impact of 12 months of EndoBarrier Therapy was studied in obese, type 2 diabetes subjects to assess the metabolic changes in subjects with minimal weight loss (≤ 2 kg) early after implantation, and the estimated effect of weight on A1C with baseline A1C and weight as independent variables. The results provide evidence for both weight loss dependent and independent metabolic effects of EndoBarrier Therapy. The contribution of a weight-independent effect appears clinically significant.

Metabolic Improvements Observed in Subjects Receiving EndoBarrier: A Pooled Analysis of Clinical Trials

J. Teare, et al, London, United Kingdom

A pooled analysis of results from six EndoBarrier clinical studies showing EndoBarrier Therapy elicited significant metabolic improvements and weight loss with an acceptable safety profile among 211 obese subjects with comorbidities.