GI Dynamics has a started a US pivotal trial of its non-surgical device, designed to treat patients with obesity and uncontrolled type 2 diabetes.
Flexible, tube-shaped EndoBarrier device, which is implanted into the gut, forms a physical barrier between food and a portion of the wall of the intestine.
The double-blind, multicenter, randomized, sham controlled trial, named ENDO, will enroll 500 patients 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, while secondary endpoint forms weight loss and improvements in select cardiovascular risk factors, such as cholesterol.
Previous clinical studies have achieved rapid reductions in blood sugar levels and weight loss of approximately 20% in 12 months, claims the company.
GI Dynamics president and chief executive officer Stuart Randle said, "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."
The company’s EndoBarrier device is also available in Europe and Australia for the treatment of type 2 diabetes and/ obesity for up to 12 months.