By expanding the trial, Emisphere will be able to evaluate the performance of all three active arms of the trial against each other for statistical significance. Without the additional patients, Emisphere would have been limited to evaluating each of the active arms against only the placebo for statistical significance.
Based on the current enrollment rate, the company expects to complete the additional enrollment within the next few weeks.
“Expanding our trial enrollment will give us a more robust data set to compare the three different dosing regimens of oral insulin being tested in this trial,” commented Dr Michael Goldberg, chairman and CEO of Emisphere Technologies. “We are pleased with the safety and activities observed to date, and are delighted that the DCGI granted us permission to increase enrollment.”