GI Dynamics® Inc. (ASX: GID), a medical device company that is developing EndoBarrier® for patients with type 2 diabetes and obesity, is pleased to announce the meta-analysis, "Effects of the Duodenal-Jejunal Bypass Liner on Glycemic Control in Type 2 Diabetic Patients with Obesity: A Meta-analysis with Secondary Analysis on Weight Loss and Hormonal Changes," by Pichamol Jirapinyo, MD, of Brigham and Women's Hospital in Boston, Massachusetts, and Diplomat of the American Board of Obesity Medicine, has been published in Diabetes Care, the journal of the American Diabetes Association.
The meta-analysis is comprised of 17 published studies that evaluate EndoBarrier (also referred to as duodenal-jejunal bypass liner [DJBL]) outcomes in patients with type 2 diabetes and obesity. The primary outcomes of the meta-analysis were change in hemoglobin A1c (HbA1c) and homeostatic model assessment of insulin resistance (HOMA-IR). Secondary outcomes were change in weight and change in hormones critical to the regulation of metabolic and bariatric disorders: GIP, GLP-1, PYY and ghrelin.
"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," said Jirapinyo. "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."
Jirapinyo's study also highlighted a clinically and statistically significant improvement in insulin resistance.
Jirapinyo conducted this study according to the PRISMA statement and reviewed over 1,000 published EndoBarrier studies. Following strict inclusion and exclusion methodologies which were defined a priori, a total of 17 published studies were included in the final meta-analysis. Jirapinyo contacted authors for additional information that was needed, which contributed to making the study robust and comprehensive.
"Given a rising pandemic of obesity and diabetes, DJBL may offer a highly effective treatment option for this patient population," said Jirapinyo.
"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," said Scott Schorer, GI Dynamics president and chief executive officer. "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," said Schorer. "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."