Clinical Results Suggest EndoBarrier® Therapy Is Effective In Overweight And Mildly Obese Type 2 Diabetes Patients

“Our data point to a substantial improvement in glycemic control and other metabolic parameters even among overweight – but not severely obese – diabetic patients during EndoBarrier Therapy”

In short

GI Dynamics Inc., developer of the EndoBarrier® therapy for obesity and Type II diabetes, tells us that a clinical study about the device was presented at the 29th Annual Meeting of the American Society for Metabolic and Bariatric Surgery Meeting in San Diego last week.

Background

We’ve covered EndoBarrier before, most recently earlier this month with the news of favourable clinical data presented at the American Diabetes Association meeting. The EndoBarrier device is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. EndoBarrier Therapy affects certain gastrointestinal hormones involved in insulin sensitivity, glucose metabolism and satiety, contributory factors towards claimed rapid and sustained improvement of type 2 diabetes and weight loss.

Now, during a plenary session on “Emerging Technologies and Concepts,” at the ASMHBS meeting, Ricardo V. Cohen, M.D., Center for the Surgical Treatment of Morbid Obesity and Metabolic Disorders, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil, has presented findings from his study, “Metabolic Improvement in Type 2 Diabetes in Subjects without Severe Obesity with the Endoscopic Duodenal-Jejunal Bypass Liner.”

This non-randomised, single-arm, single-center study evaluated EndoBarrier Therapy in 20 patients with uncontrolled type 2 diabetes and a mean body mass index (BMI) of 30.0 kg/m2 (range: 23-36) over a one-year period. Sixteen patients completed one year of EndoBarrier Therapy with the following results:

  • A statistically significant mean decrease in HbA1c of 1.1% (from 8.6% at baseline to 7.5%) (p<0.05)
  • HbA1c levels <=7.0% in 62.5% of the patients
  • A statistically significant decrease in total body weight loss of 9.4% (p<0.05)
  • Statistically significant reductions in total cholesterol (from 218 mg/dL at baseline to 189 mg/dL)(p<0.05) and LDL (from 135 mg/dL at baseline to 111 mg/dL) (p< 0.05)

Clinician comments

“Our data point to a substantial improvement in glycemic control and other metabolic parameters even among overweight – but not severely obese – diabetic patients during EndoBarrier Therapy,” remarked Dr. Cohen. “These are promising data and suggest that EndoBarrier may play a valuable role for overweight patients struggling to control their diabetes and lose weight.

Company comments

“As one of the earliest researchers of EndoBarrier Therapy, Dr. Cohen has contributed greatly to the aggregate of clinical data supporting the efficacy of our technology in improving type 2 diabetes and weight loss,” said Mark C. Twyman, chief commercial officer, GI Dynamics, Inc. “The population in this particular study had a BMI lower than any previous EndoBarrier study; and even so, EndoBarrier Therapy produced meaningful and clinically significant benefits with regard to glycemic control, weight loss and other metabolic parameters.”

Source: GI Dynamics Inc.