GI Dynamics initiates ENDO trial for treatment of Type 2 Diabetes and Obesity

GI Dynamics has initiated its U.S. multicenter pivotal clinical trial of EndoBarrier, the ENDO Trial, for the treatment of patients who have uncontrolled Type 2 Diabetes and are Obese.

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 previous clinical studies, EndoBarrier has been shown to achieve rapid reductions in blood sugar levels and weight loss of approximately 20 percent in 12 months.

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.

The EndoBarrier received CE Mark approval for Europe in 2010, as well as approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity.