GI Dynamics (ASX:GID) said today that it’s launched a U.S. pivotal trial of its EndoBarrier anti-diabetes weight loss device, hoping to use the study data to back a pre-market approval application with the FDA.
President & CEO Stu Randle told MassDevice.com that the Lexington, Mass.-based company hopes to put a PMA application before the federal watchdog agency "in late 2015."
The EndoBarrier is a plastic sleeve designed to line the gut and prevent the absorption of food. The U.S. trial will span 25 U.S. sites, enrolling up to 500 obese patients with uncontrolled Type II diabetes and assessing changes over a period of 12 months.
Randle told us that the differentiator for GI Dynamics with this trial is that its primary endpoint is reduction in blood sugar, not weight loss (which is a seconday endpoint, he said).
"The data we used overseas gave [the FDA] confidence that we’re going right to a pivotal trial," Randle said.
Earlier studies demonstrated that the EndoBarrier helps control blood sugar levels and induce weight loss of up to 20% in a year. The device won CE Mark approval in the European Union in 2010 and hit the market in Australia the next year.
"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," Randle added in prepared remarks. "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."
"We’re excited to initiate this important trial in the U.S.," added lead investigator Dr. Lee Kaplan of Mass. General Hospital. "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."