Oral Insulin Found Successful in Human Clinical Trials

Insulin  is a peptide hormone  produced by beta cells of the pancreatic islets, and it is considered to be the main anabolic hormone of the body. It regulates the metabolism of carbohydrates, fats and protein by promoting the absorption of, especially, glucose from the blood into liver, fat and skeletal muscle cells.  In these tissues the absorbed glucose is converted into either glycogen via glycogenesis or fats via lipogenesis, or, in the case of the liver, into both.

Glucose production and secretion by the liver is strongly inhibited by high concentrations of insulin in the blood. Circulating insulin also affects the synthesis of proteins in a wide variety of tissues. It is therefore an anabolic hormone, promoting the conversion of small molecules in the blood into large molecules inside the cells. Low insulin levels in the blood have the opposite effect by promoting widespread catabolism,  especially of reserve body fat.

A clinical-stage pharmaceutical company, Oramed Pharmaceuticals, has now announced the screening for diabetic patients as part of its 90-day dose-ranging Pivotal Phase 2b HbA1c clinical study of its oral insulin capsule, ORMD-0801.

A statistically significant improvement in HbA1c (glycated hemoglobin), a long-term indicator of blood sugar control, was detected in only 28 days of therapy with ORMD-0801 at Oramed’s previous Phase 2 research.  The objective of this analysis is to quantify this impact over 90 days of therapy at several doses.

The study will enroll approximately 240 patients with type 2 diabetes at numerous centers across the U.S. The main end points are security assessing adverse and hypoglycemic events, and efficiency unique to HbA1c levels over 90 days of therapy. Secondary end points include steps of fasting plasma glucose (FPG), post-prandial sugar (PPG degrees) through a mixed-meal tolerance test (MMTT) and pounds.

This is our most important study to date,” says Oramed CEO Nadav Kidron. “A year from now we will better know the potential of our drug to control and maintain blood glucose levels and will have further proof of the longer-term benefits of taking an oral pill versus an injection.”

“Not only does oral insulin offer a more convenient alternative to needles, a therapy many patients are reluctant to begin,” explains Kidron, “but it also provides a more efficient and safer platform for delivering insulin by mimicking the body’s natural process of insulin going directly to the liver rather than via the bloodstream.”