Data, which came from 234 patients enrolled in the registry, indicated a mean reduction in absolute HbA1c of 1.3%, as well as a reduction of antidiabetic medication in 78% of patients. Mean injection doses of Insulin were reduced by 42%, the company said.
“The data emerging from the German EndoBarrier Registry continues to support the strong efficacy and safety profile of EndoBarrier. We are encouraged by this early review, and look forward to continued clinical conclusions to be drawn from this rapidly expanding registry effort. We would like to thank all participating hospitals for their contribution,” prez & CEO Scott Schorer said in a press release.
Excess weight dropped a mean amount of 15kg, a 29% drop for patients in the registry, GI Dynamics said. The rate of hepatic abscesses was 1.7%, and the rate of severe bleeding was 0.4%. All safety-related events ended without long-term complications, the company added.
“Patients significantly benefitted from improvement of HbA1c, reduction of antidiabetic medication, reduction of weight and were able to improve obesity-associated comorbidities,” study presenter Dr. Nina Riedel of Germany’s University Hospital Hamburg-Eppendorf said in a prepared statement.
The company said it is continuing to expand the registry, with input from more than 300 patients so far.
Earlier this month, GI Dynamics said that Australia’s Therapeutics Goods Administration removed the EndoBarrier weight loss device from the Register of Therapeutic Goods, effectively stopping commercialization of the device in the region.
The company said it will continue to support ongoing trials, including a randomized, controlled trial exploring the treatment of nonalcoholic steatohepatitis which has been enrolling patients for 14 months.
GI Dynamics said its sales in Australia constituted approximately 15% of its worldwide revenue.