Medical devices developer GI Dynamics has obtained the US Food and Drug Administration (FDA) approval to commence enrolment in a pivotal clinical trial (GID 18-1) of its EndoBarrier implant.
EndoBarrier is an endoscopically delivered device designed to treat type 2 diabetes and obesity.
The current approval allows for the recruitment of approximately 67 patients, 50 of which will receive the EndoBarrier implant. The remaining 17 are the control participants.
This enrolment is subject to receipt of additional funding and is expected to be completed in the first half of next year.
GI Dynamics plans to seek authorisation for the enrolment of an additional 173 subjects, after the FDA reviews the trial’s interim safety report.
GID 18-1 is intended to assess the safety and efficacy of EndoBarrier on a comprehensive basis over a period of one year. The trial will involve a follow-up duration of one year.
The primary endpoint of the trial is a decrease in average blood sugar levels (HbA1c) at one year.
Both implant and control arms will receive identical lifestyle therapy.
GI Dynamics president and CEO Scott Schorer said: “This IDE approval is the result of more than two years of scientific investigation and research focused on clinical trial design in collaboration with the FDA, with the intent of designing a robust pivotal trial focused on the treatment of type 2 diabetes.
“EndoBarrier remains one of the few technologies focused on the primary target of achieving glycemic control for patients diagnosed with type 2 diabetes that is not bariatric/metabolic surgery or anti-diabetes medication.”
The company and the FDA have determined certain safety events that will lead to termination of enrolment, including device-related bleeding that will need transfusion or embolisation or intensive care unit (ICU) care.