Glycemic Control Demonstrated In Mildly Obese Type 2 Diabetics With Endobarrier® Therapy

In short

GI Dynamics, Inc. has seen its EndoBarrier device in print again with the publication of clinical research showing that use of the therapy produced a statistically significant decrease in mean HbA1c and total cholesterol levels over a one-year period.

Background

The diagnosis of type 2 diabetes usually occurs after the age of 40 and is often, but not always, associated with obesity. The EndoBarrier® device has been shown to be effective in treatment of obese patients, but thus far its effectiveness has not been fully examined in patients with Type 2 Diabetes and only mild obesity, until now.

In this open-label, single-centre study, researchers evaluated one year of EndoBarrier Therapy in 20 patients with uncontrolled type 2 diabetes and a mean body mass index (BMI) of 30 kg (≥26 to ≤ 50 kg/m2). In the 16 patients that completed the one-year treatment period, the study findings show the following results:

  • HbA1c levels of ≤ 7.0 achieved by 60 percent of study subjects at six months of treatment
  • 10 out of 16 completer subjects (62.5 percent) achieved HbA1c levels of ≤ 7.0 percent
  • A statistically mean decrease in HbA1c of 1.1 percent (from 8.6 percent at baseline to 7.5 percent; p=0.004)
  • Mean fasting plasma glucose (FPG) changed from 207 ± 61 mg/dL at baseline to 139 ± 37 mg/dL one week after EndoBarrier implantation. At week 52, FPG was 155 ± 52 mg/dL in the 16 subjects who completed the study, representing a mean change from baseline of -45.8 ± 63.9 mg/dL (P = .012)
  • Change in total cholesterol from 220 mg/dL at baseline to 188 mg/dL, and LDL from 135 mg/dL at baseline to 108 mg/dL

Physician comments

“These data demonstrate the powerful impact that EndoBarrier Therapy can have in helping people with type 2 diabetes achieve reduced HbA1c levels,” stated Ricardo V. Cohen, M.D., Center for the Surgical Treatment of Morbid Obesity and Metabolic Disorders, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil. “Diabetes is a challenging disease to effectively manage and there is a great need for new approaches to help patients achieve metabolic control. These findings suggest and support further consideration of EndoBarrier Therapy as an effective adjuvant treatment option for patients with type 2 diabetes and lower BMIs.”

Company comments

“We are pleased with the results from this initial study evaluating EndoBarrier Therapy use in people living with type 2 diabetes who have a lower BMI,” said Stuart A. Randle, president and CEO, GI Dynamics. “Our launch efforts in our current target market of obese people with type 2 diabetes are going very well, and we believe the lower BMI population represents an exciting market expansion opportunity going forward.”

Regulatory status

EndoBarrier is approved to treat type 2 diabetes and/or obesity in multiple countries outside of the United States and is considered an investigational device for the treatment of type 2 diabetes in the United States.

Source: GI Dynamics, Inc.