GI Dynamics, Inc. has announced that it has initiated its U.S. multicentre pivotal clinical trial of EndoBarrier®, the ENDO Trial, for the treatment of patients who have uncontrolled type 2 diabetes and are obese.
We’ve covered Endobarrier’s progress over the past year, most recently last week when the developer, GI Dynamics, unveiled two new collaborative research agreements which it hopes will provide information about how the device works in ameliorating both obesity and diabetes.
Previous clinical studies have shown rapid reductions in blood sugar levels and weight loss of approximately 20 percent in 12 months.
Now the company is kicking off its pivotal US study which it expects will ultimately lead to FDA approval. The so-called ENDO Trial is a randomised, double-blind, sham controlled, multi-centre 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.
“We’re excited to initiate this important trial in the U.S.,” said Lee M. Kaplan, M.D., Ph.D., lead investigator and director of the Obesity, Metabolism & Nutrition Institute at the Massachusetts General Hospital and Harvard Medical School. “Results from the pilot studies of EndoBarrier have been very promising, and we look forward to determining the efficacy and safety of this device in this large, controlled, pivotal trial.”
“The start of our U.S. pivotal trial marks a major milestone on the road to bringing EndoBarrier to the millions of people in this country living with type 2 diabetes,” said Stuart A. Randle, president and chief executive officer, GI Dynamics. “We appreciate the support of our investigators and clinical trial sites as we begin the process of enrolling patients and executing this landmark clinical trial.”
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.