The US Food and Drug Administration (FDA) has granted full approval to GI Dynamics to initiate its ENDO trial, designed to assess the safety and efficacy of EndoBarrier liner in treating patients with uncontrolled type 2 diabetes and obesity.
The flexible, tube-shaped non-surgical 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, randomised, multi-centre, sham-controlled pivotal 25-site trial, which is expected to enrol 500 people, 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, while the secondary endpoints are weight loss and improvements in select cardiovascular risk factors, such as cholesterol.
12 previously conducted clinical studies on the EndoBarrier liner have shown rapid reductions in blood sugar levels, improvements in cardiovascular risk factors including blood pressure, cholesterol and triglycerides, and weight loss of approximately 20% in 12 months.
GI Dynamics president and CEO Stuart Randle said seeing the benefits the device has brought to people living with type 2 diabetes has been very rewarding.
"We are very pleased to now have full approval in the US to commence a pivotal trial of this novel therapy," Randle said.
"We look forward to providing updates on the progress of the ENDO trial and to submitting the results for PMA approval to sell EndoBarrier in the United States."
The device is commercially available in selected countries in Europe including Germany, Austria, the UK and the Netherlands, as well as Australia and Chile.