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Trial Shows Insulin Capsules Reduce Blood Glucose Levels

Capsules in bubble package

(HeungSoon, Pixabay.

29 Nov. 2022. Results of a clinical trial reveal an optimal dose for an insulin capsule that in 12 weeks reduces blood glucose levels in patients with type 2 diabetes. Findings from the trial testing insulin capsules made by Oramed Pharmaceuticals Inc. are reported in the 24 Oct. issue of the journal Diabetes, Obesity, and Metabolism (Full text available on the company’s web site).

Oramed Pharma, based in New York and Jerusalem, develops protein drugs, usually given by injection, for oral delivery. The company says its technology protects therapeutic protein or peptide components from stomach acids and protease enzymes that would normally break them down, enabling the proteins or peptides to be released in the small intestine. Oramed says its process also adds components that help large, complex molecule proteins permeate intestinal membranes, to enhance their absorption into the blood stream.

The company’s lead product, code-named ORMD-0801, is an oral form of insulin for people with type 2 diabetes. Diabetes is a chronic disease where the pancreas does not produce sufficient insulin to process the sugar glucose in the blood stream that provides energy for cells in the body. In type 2 diabetes that accounts for at least 90 percent of all diabetes cases, the pancreas produces some but not enough insulin, or the body cannot process insulin. Type 1 diabetes is an autoimmune condition where the immune system attacks islet or beta cells in the pancreas, thus preventing insulin production. Some 37.3 million people in the U.S. have some form of diabetes, according to Centers for Disease Control and Prevention.

Determine optimal dose and regimen

Most people with diabetes needing external sources of insulin use injections with syringes to fulfill their needs. Oramed Pharma is currently testing ORMD-0801 that delivers insulin as a capsule in two late-stage clinical trials. In Nov. 2020, Science & Enterprise reported on the start of one of those trials.

The new journal paper provides findings from an earlier mid-stage clinical trial to help determine an optimal dose and regimen for taking ORMD-0801, as well as provide data on its safety and efficacy, measured by changes in HbA1C or hemoglobin glucose levels. The trial enrolled 373 participants with type 2 diabetes, testing multiple dosage levels and taking capsules from one to three times a day, against a placebo also taken in those dosages and time intervals. The study team measured HbA1C in participants at the start of the trial and after 12 weeks.

Results show participants taking ORMD-0801 at all dosage levels and intervals reduced their HbA1C levels after 12 weeks , compared to participants taking a placebo. The study team also found the capsules were safe and well tolerated, without associated weight gain or incidents of low blood sugar, known as hypoglycemia. The authors conclude the minimum ORMD-0801 dose of 8 milligrams taken once a day at bedtime should be continued as the regimen tested in phase 3 or late-stage trials.

“This paper presents interesting and important results of Oramed’s phase 2 dose ranging study of oral insulin,” says endocrinologist Roy Eldor, lead author of the paper and director of the diabetes unit at Tel Aviv Sourasky Medical Center in a Oramed Pharma statement released through Cision. “Based on the results of this study, a bedtime dose of 8 mg is being carried forward into the phase 3 registration studies.”

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