GI Dynamics has obtained conditional approval from the US Food and Drug Administration (FDA) to initiate a pivotal clinical trial of its 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.
The company said after the implantation, the device has shown to affect certain gastrointestinal hormones involved in insulin sensitivity, glucose metabolism and satiety, which allowed for sustained improvement of type 2 diabetes and weight loss.
The double-blind, randomized, multi-center, 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 includes weight loss and improvements in select cardiovascular risk factors, such as cholesterol.
The trail is expected to enroll 500 people living with uncontrolled diabetes and obesity who meet the enrollment criteria at 25 sites in the US.
GI Dynamics president and chief executive officer Stuart A. Randle said going directly into a pivotal trial eliminates the need for a pilot trial and has the potential to accelerate commercialization of the EndoBarrier in the US.
"We look forward to continuing to work with the Agency to finalize the remaining details of the study and expect to initiate the trial before the end of the year," Randle added.