The glucose clamp is a method for quantifying insulin absorption in order to measure a patient’s insulin sensitivity and how well a patient metabolizes glucose. The glucose clamp technique represents the gold standard for pharmacodynamic studies in diabetes drug development.
In addition to the clamp study, Oramed plans to initiate its Phase IIb oral insulin trial in the U.S. with a protocol which includes over 30 U.S. sites covering approximately 180 patients and has both efficacy and safety as its primary end-points.
“We are pleased to have initiated this study and enrolled the first patient. We are additionally excited at the prospects of starting our larger Phase IIb trial in the near term. The data from the two trials will allow for a clearer picture of our oral insulin and its pharmacological characteristics as we move forward with our development plan,” stated Oramed CEO