LEXINGTON, Mass., October 27, 2009 – GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and obesity, today announced data which support the safety and efficacy of the EndoBarrierTM Gastrointestinal Liner for pre-surgical weight loss treatment, along with a positive effect on glucose homeostasis in morbidly obese patients with type 2 diabetes mellitus. According to the study, mean excess weight loss (EWL) achieved after 12 weeks post implantation was 19.0 % for EndoBarrier patients versus 6.9 % for control patients (p<0.002). The results of this European weight loss study were published today in the advance online publication of Annals of Surgery.
“As worldwide incidence of obesity has nearly doubled, and more than 200 million people worldwide suffer from type 2 diabetes, there is an increasing and significant unmet need for safe and effective non-surgical treatment options for these twin epidemics,” stated Jan Willem Greve, M.D., Ph.D., Gastrointestinal and Bariatric Surgery, Atrium Medical Center Parkstad Heerlen, Netherlands, and study co-author. “These data published in Annals of Surgery reflect the first European experience with the EndoBarrier, and also reinforce the promising weight loss data seen in clinical studies with the EndoBarrier to date.”
The clinical trial was designed to examine the safety and efficacy of the EndoBarrier in morbidly obese patients. In a multi-center, randomized clinical trial, 41 patients were enrolled and 37 patients were treated. Twenty-six patients received the EndoBarrier and 11 were in the diet control group. The EndoBarrier was implanted for 12 weeks. Three patients kept the device implanted for 24 weeks. Patients in both the EndoBarrier and diet control groups followed the same diet during the study period. Starting average weight for these two groups was similar with 142.5 kg (314.2 lbs) for EndoBarrier patients versus 137.5 kg (303.2 lbs) for control group patients, and body mass index (BMI) of 48.9 versus 49.2, respectively.
Mean excess weight loss (EWL) achieved after 12 weeks was 19.0 % for EndoBarrier patients versus 6.9 % for control patients (p<0.002). In the 3 patients that kept the EndoBarrier implanted for 24 weeks, the EWL was 24.3%. Absolute change in BMI at 12 weeks was 5.5 and 1.9 kg/m2, respectively. Type 2 Diabetes mellitus was present at baseline in 8 patients of the device group and improved in 7 patients during the 12 week study period (lower glucose levels, HbA1c and medication requirements). Notably, 6 out of 8 patients in the device group decreased insulin dosages and/or oral anti-diabetic medication after one week. At 12 weeks, there was still an ongoing improvement in 5 patients (continuous lowering of medication requirements), and 1 patient was able to completely stop diabetes medication.
“These promising data in morbidly obese patients reinforce the potential of EndoBarrier as an innovative, non-surgical therapeutic for patients battling obesity and type 2 diabetes,” said Stuart A. Randle, chief executive officer of GI Dynamics. “This was the first European clinical weight loss study conducted with the EndoBarrier, and since then the EndoBarrier has been successfully implanted in more than 250 patients. As GI Dynamics has expanded the clinical development program for EndoBarrier in patients with obesity and type 2 diabetes, we have continued to see impressive results, and have been able to continuously refine our device and improve the implantation procedure.”
GI Dynamics is defining a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Unlike traditional pharmaceutical approaches, non-surgical therapeutics remove the burden of dose regimen compliance from the patient. Additionally, non-surgical therapeutics hold the potential to improve the patient’s overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented.
The full study can be accessed online at http://journals.lww.com/annalsofsurgery/toc/publishahead, and will also be published in an upcoming print issue of Annals of Surgery.