500 Patient EndoBarrier® Pivotal Clinical Trial OK’d By FDA

In short

GI Dynamics, Inc. has announced that it has received conditional approval from the U.S. FDA to commence what it’s calling a pivotal clinical trial of the EndoBarrier® for the treatment of patients who have uncontrolled type 2 diabetes and are obese.

Background

Estimates indicate that type 2 diabetes affects more than 23 million people in the United States2, and approximately 320 million people worldwide3. Type 2 diabetes, which accounts for approximately 90 percent of all cases of diabetes and is often, but not always, associated with obesity.

We’ve covered EndoBarrier quite extensively on our pages, not least because we’re intrigued about the sheer simplicity of the proposal. The device is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. Once implanted, the EndoBarrier has been shown to affect certain gastrointestinal hormones involved in insulin sensitivity, glucose metabolism and satiety(1), and these changes allow for rapid and sustained improvement of type 2 diabetes and weight loss.

The Clinical Trial

The pivotal trial is a randomised, multi-centre, double-blind, sham controlled trial that is expected to enroll approximately 500 people living with uncontrolled diabetes and obesity who meet the enrollment criteria at 25 sites in the United States. The trial is designed to assess improvements in diabetes over a treatment period of up to 12 months. The primary endpoint of the trial is improvement in HbA1c (a key blood sugar measure for diabetes); secondary measures include weight loss and improvements in select cardiovascular risk factors, such as cholesterol.

Conditional approval from the FDA indicates the Agency is in agreement with the overall trial design and, while minor details are being finalised, allows the Company to move forward with the Institutional Review Board (IRB) approval process required prior to enrolling patients into the pivotal study.

Company comments

“We are very pleased that the Agency has chosen to recognize the substantial amount of scientifically sound data generated from our clinical trials conducted outside the United States, allowing us to move directly into a pivotal trial,” said Stuart A. Randle, president and chief executive officer, GI Dynamics. “Going directly into a pivotal trial eliminates the need for a pilot trial and has the potential to accelerate commercialization of the EndoBarrier in the U.S. We look forward to continuing to work with the Agency to finalize the remaining details of the study and expect to initiate the trial before the end of the year.”

Regulatory status/availability

GI Dynamics currently markets the EndoBarrier in select regions in Europe, South America and Australia and is planning near-term commercial expansion into additional European countries. The product is not approved for sale in the United States and is considered investigational.

References

[1] C de Jonge, JW Greve, N Bouvy, et al, EndoBarrier Gastrointestinal Liner treatment rapidly improves diabetes parameters paralleled by increased postprandial GLP-1 and PYY levels in obese type 2 diabetic patients, Department of Surgery, Maastricht University Medical Centre, presented at IFSO 2011, Hamburg, Germany.

[2] Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011.

[3] International Diabetes Federation, 5th edition of the Diabetes Atlas, 2011.

Source: G I Dynamics Inc.