Initial results show the duodenal jejunal bypass liner (DJBL) technology met overall glycemic control efficacy and SAE related device removal safety endpoints
Findings Presented at DDW 2022
BOSTON – June 15, 2022 – GI Dynamics, a medical device company that is developing the EndoBarrier® System for patients diagnosed with type 2 diabetes and obesity, announced results from a multicenter study evaluating GI Dynamic’s EndoBarrier® System intended for patients who do not have adequate control of their type 2 diabetes and obesity through their current medication and lifestyle. The data was presented at the annual Digestive Disease Week (DDW) conference in May.
Results from a Multicenter Randomized Sham-controlled Trial of a Duodenal Jejunal Bypass Liner for the Treatment of Type 2 Diabetes Mellitus were presented by Christopher C. Thompson, M.D., Professor at Harvard Medical School and Director of Endoscopy at Brigham and Women’s Hospital.
The study enrolled patients from 2013-2015 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 Dr. Thompson. “This novel approach is promising and has the potential to offer patients and clinicians another safe and effective treatment option.”
GI Dynamics stopped the ENDO Trial in 2015, prior to completing enrollment due to a higher than anticipated incidence of liver abscesses. In 2019, the company launched a new US IDE study, the STEP-1 Study, in the United States to study the EndoBarrier System. 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 STEP-1 Trial is currently enrolling patients at 5 clinical study sites across the US.
About GI Dynamics
GI Dynamics Inc. is the developer of the EndoBarrier® System, an endoscopically delivered device therapy that offers a non-surgical, alternative treatment for the treatment of type 2 diabetes and obesity. EndoBarrier® is not approved for sale in the United States and is limited by federal law to investigational use only.
Founded in 2003, GI Dynamics is headquartered in Boston, Massachusetts. For more information, please visit gidynamics.com.