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Oral Insulin Capsule for Type 2 Diabetes Shows Promise in Phase II Trial
Study meets all endpoints (January 30)
Positive results have been reported from a phase IIa trial of an oral insulin capsule (ORMD-0801) for the treatment of patients with type 2 diabetes mellitus. The study met all of its primary and secondary endpoints.
Thirty adult patients (aged 20 to 70 years) with early-stage type 2 diabetes participated in the study in an inpatient setting for 1 week. The patients’ diabetes was inadequately controlled with diet and exercise, or with diet, exercise, and metformin.
Each patient received multiple oral bedtime doses of ORMD-0801 or placebo. Endpoints of safety as well as the pharmacodynamic and pharmacokinetic effects of ORMD-0801 versus placebo were evaluated.
According to the treatment’s developer (Oramed Pharmaceuticals), ORMD-0801 is intended for patients with the early stages of type 2 diabetes mellitus, when the therapy may slow the rate of degeneration of the disease by providing additional insulin to the body and by allowing pancreatic respite. In addition, orally administered insulin mimics insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.
A phase IIa trial of ORMD-0801 in type 1 diabetes is being planned.
Source: PR Newswire; January 30, 2014.