The UNC Diabetes Care Center announced today that it is actively enrolling patients in the ENDO Trial, a pivotal clinical trial of EndoBarrier® for the treatment of patients who have uncontrolled type 2 diabetes and are obese. The ENDO Trial, EndoBarrier: a Novel therapy for type 2 Diabetes in Obese adults, will evaluate the efficacy and safety of EndoBarrier, a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine.
“There are many people living with type 2 diabetes and obesity who are trying tirelessly to manage their diabetes and blood sugar without success.”
“There are many people living with type 2 diabetes and obesity who are trying tirelessly to manage their diabetes and blood sugar without success,” offered site investigator Dr. Laura Young of the UNC Diabetes Care Center. New treatment options to help people with diabetes improve their disease are long overdue. We look forward to enrolling patients in this trial and the potential that EndoBarrier may offer in helping patients improve their diabetes.”
The prevalence of diabetes continues to grow at significant rates across the country. The U.S. Centers for Disease Control and Prevention recently reported that the prevalence of diagnosed diabetes is now greater than 6 percent of the population in all states as well as Washington, D.C. and Puerto Rico. Type 2 diabetes, which accounts for approximately 90 percent of all cases of diabetes, affects more than 23 million people in the U.S. The diagnosis of type 2 diabetes usually occurs after the age of 40 and is often, but not always, associated with obesity.
The ENDO Trial is currently enrolling adults between the ages of 21 and 65 who have uncontrolled type 2 diabetes and are obese. Eligible patients should currently be using metformin, a sulfonylurea, or a combination of both, but unable to achieve adequate glycemic control. More information about the ENDO Trial can be found at www.endobarriertrial.com or by calling 1-888-9STUDY9 (1-888-978-8399).
People Interested in enrolling in the ENDO trial at UNC should call Milana Dezube at 919-957-5684.
EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. In 12 clinical studies conducted outside the United States and one conducted in the United States, with more than 500 patients, EndoBarrier has been tested in similar patient populations. EndoBarrier received CE Mark approval in 2010, and approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity for up to 12 months. EndoBarrier is now pursuing commercial status in the United States. The first step in this process is a successful completion of the ENDO Trial. The device was developed by GI Dynamics, Inc., based in Lexington, Mass. More information about the company may be found at www.gidynamics.com.
About the ENDO Trial
The ENDO Trial is a randomized, double-blind, sham controlled, multi-center trial that is expected to enroll approximately 500 people living with uncontrolled diabetes and obesity who meet specific enrollment criteria at up to 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 improvement in select cardiovascular risk factors, such as cholesterol. For more information, visit www.endobarriertrial.com.