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 EndoBarrier™ 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.