EndoBarrier Gastrointestinal Liner: Pivotal trial final data

Final data from 320 inadequately controlled obese patients with Type II diabetes in the modified intent-to-treat (mITT) population of the double-blind, U.S. pivotal ENDO trial showed that EndoBarrier Gastrointestinal Liner reduced mean HbA1c from baseline to 12 months by 1.1% vs. 0.3% for sham control. Additionally, a significantly greater proportion of patients treated with EndoBarrier achieved an HbA1c of <=7% at 12 months vs. sham (34.8% vs. 9.8%, p=0.0003). EndoBarrier also significantly reduced mean body weight from baseline to 12 months vs. sham (8.5 vs. 2.4 kg, p<0.0001). Data were presented at the American Diabetes Association meeting in New Orleans. ...