The study enrolled patients from 2013 to 2015 and included subjects randomized to DJBL and to a sham procedure with moderate-intensity lifestyle intervention. Primary endpoints included safety, defined as an incidence of serious adverse event (SAE)-related early device removal of ≤15%, and efficacy of glycemic control demonstrated by mean change in HbA1c at 12 months with a superiority margin of ≥0.4% HbA1c over sham.
Analysis revealed that the EndoBarrier System met overall glycemic control efficacy and SAE-related device removal safety endpoints, while also providing clinically significant weight loss and comorbidity improvement.
“Insulin therapy is associated with poor long-term outcomes in patients with type 2 diabetes mellitus and obesity, and bariatric surgery is effective for glycemic control but is higher risk than medical therapy. EndoBarrier is a less invasive intermediate alternative for this struggling population,” said Christopher Thompson, MD, one of the presenters of the Endobarrier data at DDW. “This novel approach is promising and has the potential to offer patients and clinicians another safe and effective treatment option.”
The EndoBarrier is intended for patients who do not have adequate control of their type 2 diabetes and obesity through their current medication and lifestyle.
The device creates a barrier between food and the wall of the small intestine and thereby changes metabolic pathways by controlling how food moves through the digestive system. The effects are supposed to be like gastric bypass surgery, but without the surgical procedure and hospital stay.
Problems for GI Dynamics’s EndoBarrier began in 2014 when the company announced there had been an anonymous complaint to the Therapeutic Goods Administration Complaints Resolution Panel about an Australian advertisement.
A few months after the complaints, GI Dynamics said its Notified Body in the European Union had temporarily suspended commercial shipments. This stop shipment was lifted at the beginning of December 2014.
GI Dynamics problems with the Endobarrier escalated when four cases of hepatic abscess were found among the 325 patients enrolled in the ENDO trial, forcing the company to stop the study in 2015. The company would then have the CE mark for the device suspended and ultimately revoked.
However, in 2019 the company launched a new US IDE study, the STEP-1 Study, in the United States to study the EndoBarrier System. The STEP-1 Trial is currently enrolling patients at 5 clinical study sites across the US.
