GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced initial, positive results from a clinical trial evaluating 12 months of treatment with the EndoBarrier™ Gastrointestinal Liner. The first group of patients from this trial have successfully completed 12 months, or 52 weeks, of treatment with the EndoBarrier Gastrointestinal Liner, an important milestone in the clinical development of this non-surgical therapeutic. The clinical trial was led by Eduardo G. Moura, M.D., Ph.D., director of endoscopy, digestive surgery department, Hospital das Clinicas, University of Sao Paulo, Brazil.
“Successful 12-month implantation with the EndoBarrier is a clinically important achievement and a promising indicator that this non-surgical medical device may offer our patients an innovative new solution to simultaneously combat both type 2 diabetes and obesity”
“Successful 12-month implantation with the EndoBarrier is a clinically important achievement and a promising indicator that this non-surgical medical device may offer our patients an innovative new solution to simultaneously combat both type 2 diabetes and obesity,” commented Keith Gersin, M.D., FACS, chief of bariatric surgery at Carolinas Medical Center and chief medical director of GI Dynamics. “The data we have seen previously in patients treated for up to six months is very compelling, and these data from 52 weeks of treatment further extend the potential impact and efficacy of this approach. I look forward to the full data set from this trial as the rest of the patients complete the 12-month mark.”
The 52-week trial was designed to evaluate the EndoBarrier Gastrointestinal Liner in 22 obese patients with type 2 diabetes. The primary endpoints in the trial include improvement in type 2 diabetes and excess weight loss. To date, the first six of the 22 subjects implanted with the EndoBarrier have successfully reached the 52-week endpoint.
The average baseline weight for the subjects was 270.5 lbs (± 22.2 1bs), average baseline HbA1c was 9.3% (± 0.8%) and subjects were taking oral anti-diabetes medications. Top-line results for the first six subjects show that on average patients achieved the following results:
- HbA1c decrease of 2.5% (± 0.6%) with 5 of the 6 getting below 7.0%
- 25.9 % excess body weight loss (± 4.6%)
- 35.5 lbs weight loss (± 9 lbs)
“This is a landmark achievement for the EndoBarrier and GI Dynamics,” said Stuart A. Randle, chief executive officer of GI Dynamics. “I want to congratulate and thank our technical, clinical and scientific teams for their efforts which have led us to a successful 12-month device design and the meaningful results we have observed clinically to-date. We believe that EndoBarrier is well positioned to provide a transformative alternative to pharmaceutical and surgical methods for treating type 2 diabetes and obesity. This milestone further enhances the potential clinical value of the EndoBarrier offering.”
Addressing Unmet Need for Treating Type 2 Diabetes and Obesity