The Phase IIb study for type 2 diabetes is designed to generate ample data for both safety and efficacy endpoints. The double-blind, randomized study will recruit approximately 180 patients.
Oramed CEO, Nadev Kidron, made the following statement: “This pivotal study is a huge step for Oramed, as it will enable us to demonstrate the potential of our oral insulin capsule in a large clinical study. We look forward to completing the study and presenting the data collected.”
About ORMD-0801 Capsule for Type 2 Diabetes
ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or even eliminating late-stage complications. Orally administered insulin is expected to bring result in enhanced patient compliance. In addition, intestinally absorbed-oral insulin actually mimics insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.