Memorandum

German Diabetes Society releases statement on GI Dynamics’ US ENDO trial termination - October 16, 2015

GI Dynamics recently announced that the German Diabetes Society released a statement regarding the termination of the company’s US ENDO trial for its obesity device EndoBarrier. As background, GI Dynamics terminated the trial this past July (after the trial was put on hold in March) due to it exceeding the 2% tolerance threshold for the occurrence of liver abscesses (3.2% in intervention group vs. 0% in sham [control] group). Notably, and separately from this difficulty, the Society’s statement provided an interim analysis of the data, demonstrating a statistically significant A1c reduction in the intervention group. At 12 months, the A1c dropped 1.3% in the intervention group vs. 0.2% in the sham group (baseline A1c of 8.8%). The statement also raised hypotheses on the trial’s high abscess rates suggesting that contributing factors may include the study protocol’s higher dose of proton pump inhibitors and the increased liver abscess risk in participants with type 2 diabetes. The US trial’s rates of abscesses were reported to be significantly higher than the rate observed elsewhere, with rates of only 0.7% and 0.5% based on international and German registers, respectively, which suggests the problem is avoidable. Regarding treatment and prevention, the statement noted that the protective effects of prophylactic cyclical administration of antibiotics against liver abscesses remain unknown. The statement also suggested that since international registers show that these abscesses typically occur between 10 and 12 months after the device’s implantation period, explanation (removal) after 10 months can be considered, as this may minimize risk of the complication. We ultimately hope to see greater research into the mechanisms behind the trial’s higher abscess rate to help translate these theories into more concrete clinical guidance as this statement points out the possibility of EndoBarrier as an effective treatment option if clinicians are provided with the right tools to manage the known risks.