A non-surgical treatment for Type 2 diabetes and obesity recently reached an important clinical milestone, according to the company that developed the device, GI Dynamics (Lexington, Massachusetts).
This week GI Dynamics reported initial results from a clinical trial evaluating 12 months of treatment with its EndoBarrier Gastrointestinal Liner. The first six of 22 patients from this trial have reached the 12-month endpoint, GI said. The primary endpoints in the trial were improvement in Type 2 diabetes and excess weight loss.
Top-line results for these patients show that on average, patients achieved the following results: HbA1c decrease of 2.5% with five of the patients getting below 7% (average baseline HbA1c was 9.3%); 25.9% excess body weight loss; and 35.5 pounds weight loss (average baseline weight was 270.5).
“Certainly our goal all along was to develop an implant that could stay in place for a year,“ Keith Gersin, MD, chief of bariatric surgery at Carolinas Medical Center (Charlotte, North Carolina) and chief medical director of GI Dynamics, told Medical Device Daily. “We've been able to achieve that with really excellent results.“
The device is placed in the GI tract through the mouth to create a barrier between food and the wall of the intestine. Doctors believe that preventing food from coming into contact with the intestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery, the company said.
“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,“ Gersin said. “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.“
When asked what kind of feedback he has received from his colleagues in the field about the EndoBarrier device, Gersin was quick to say that, “they're all very excited – they want in.“
“They all want to know when they can participate in trials and when it will be available,“ he added.
Eduardo Moura, MD, PhD, director of endoscopy, digestive surgery department, Hospital das Clinicas, University of Sao Paulo (Brazil) led this clinical trial.
Type 2 diabetes affects an estimated 21 million Americans and 200 million people worldwide. According to the World Health Organization (Geneva), Type 2 diabetes comprises 90% of people with diabetes around the world, and is largely the result of excess body weight.
GI Dynamics also is developing the EndoBarrier Flow Restrictor, which is designed to further enhance the effectiveness of the liner by doubling the amount of weight-loss that can be achieved using the liner alone. Each device in the EndoBarrier portfolio is designed to assist patients gain control of their blood sugar and achieve a healthier body mass index, the company noted. GI Dynamics said it is collaborating with experts in endocrinology, gastroenterology, bariatric surgery and medical weight loss on these efforts.
“This is a landmark achievement for the EndoBarrier and GI Dynamics,“ said Stuart Randle, CEO of GI Dynamics. “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.“
The EndoBarrier received European CE-mark approval for the treatment of Type 2 diabetes and obesity late last year (Medical Device Daily, Dec. 23, 2009). That approval came less than two months after the company reported favorable results of a European weight loss study published in the Annals of Surgery (MDD, Nov. 3, 2009).
Jonathan Hartmann, VP of sales and marketing for GI Dynamics, told MDD in December that the patients who get the EndoBarrier liner are seeing an immediate improvement in their Type 2 diabetes, within the first week. The weight loss occurs over time, similarly to the results a patient could expect to see after having weight loss surgery, he said.
“We've tried to position ourselves to be more effective than medicine and less invasive than surgery,“ Gersin said.
Clinical trials to date involving more than 280 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner, the company noted.
Advanced Technology Ventures, Catalyst Health Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson (New Brunswick, New Jersey), Medtronic (Minneapolis) and Polaris Venture Partners are among the investors backing GI Dynamics.
Amanda Pedersen, 229-471-4212;