Oramed Pharmaceuticals has submitted the study protocol for the company's Phase IIb trial of ORMD-0801, its oral insulin capsule, to 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.