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# Oramed Reports ‘Positive’ Results on Oral Insulin Study
- URL: https://www.fdaweb.com/oramed-reports-positive-results-on-oral-insulin-study/
- Published: 2016-05-18T12:00:00.000Z
- Updated: 2026-09-14T21:03:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135707

Oramed Pharmaceuticals has announced “positive top-line results” from its Phase 2b study that was designed to evaluate the safety and efficacy of its oral insulin capsule (ORMD-0801) in patients with Type 2 diabetes. The study’s primary endpoint, a significant reduction in weighted mean night-time glucose, was successfully achieved, the company says. A Phase 3 trial is now being planned.

The double blind, 28 day, randomized study of 180 adult Type 2 diabetic patients showed a night-time glucose mean percentage change of 6.47% from run-in, between placebo and active cohorts, it says, adding that the study demonstrated a good safety profile with no drug related serious adverse events.

“RMD-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,” Oramed says. “Orally administered insulin is expected to enhance patient compliance. In addition, intestinally absorbed-oral insulin mimics insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.”