Oramed Pharmaceuticals has submitted the study protocol for the company's Phase IIb trial of ORMD-0801, its oral insulin capsule, to the U.S. Food and Drug Administration (FDA). The submission was made under the company's existing Investigational New Drug (IND) application.
The Phase IIb study of ORMD-0801 for type 2 diabetics is designed to generate ample data for both efficacy and safety endpoints. The double-blind, randomized study will recruit approximately 180 patients and has a 28-day treatment period. The study has already received Institutional Review Board (IRB) approval and patient enrollment is expected to start in the short term.