The US Food and Drug Administration (FDA) has granted a conditional approval to initiate a pivotal clinical trial of GI Dynamics’ non-surgical EndoBarrier device.
Flexible, tube-shaped EndoBarrier liner, which forms a physical barrier between food and a portion of the wall of the intestine, is implanted into the gut for the treatment of uncontrolled type 2 diabetes and obesity.
After the implantation, the device will be made to affect selective gastrointestinal hormones involved in insulin sensitivity, glucose metabolism and satiety, which the company claims help in sustained improvement of type 2 diabetes and weight loss.
The double-blind, randomised, multi-centre, sham-controlled pivotal 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, while secondary endpoint forms weight loss and improvements in select cardiovascular risk factors, such as cholesterol.
The trial is expected to enrol 500 people with uncontrolled diabetes and obesity, who meet the enrolment criteria at 25 sites in the US.
GI Dynamics president and chief executive officer Stuart A Randle said the agency has granted conditional approval based on the data generated from the company’s previous clinical trials, conducted outside the US.
"Going directly into a pivotal trial eliminates the need for a pilot trial and has the potential to accelerate commercialisation of the EndoBarrier in the U.S," Randle said.
"We look forward to continuing to work with the Agency to finalise the remaining details of the study and expect to initiate the trial before the end of the year."