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Trial Underway Testing Insulin Capsules

Capsules

(Ranys Tuunainen, Pixabay)

25 Nov. 2020. Researchers began screening participants for a clinical trial assessing insulin formulated as capsules for people with type 2 diabetes. The trial is testing the drug code-named ORMD-0801, sponsored by its developer Oramed Ltd. in New York and Jerusalem, Israel.

Oramed reformulates protein-based therapies as oral drugs, beginning with insulin needed by people with diabetes. Diabetes is a chronic disorder where the pancreas does not create enough of the hormone insulin to process the sugar glucose to flow into the blood stream and cells for energy in the body. In type 2 diabetes, which accounts for at least 90 percent of all diabetes cases, the pancreas produces some but not enough insulin, or the body cannot process insulin. According to the International Diabetes Federation, diabetes affects an estimated 463 million people worldwide, of which 51 million are in North America.

For people with diabetes, insulin needs to injected into the blood since, like other proteins, insulin cannot be taken as an oral drug because it interacts chemically with acids and enzymes in the digestive system. And because insulin is a large, complex molecule, it is not readily absorbed through the wall of the small intestine.  Oramed says its technology enables insulin delivery in a capsule, with a coating that protects the insulin against digestive acids and enzymes. Oramed capsules also have an agent that improves absorption of insulin payloads in the small intestine.

The phase 3, or late-stage, clinical trial is enrolling 675 adult participants in California with type 2 diabetes, but not able to adequately control their blood glucose levels, even with current diabetes drugs. Participants are randomly assigned to receive ORMD-0801 as 8 milligram capsules taken either once or twice a day, or a fish oil placebo for 26 weeks. After 26 weeks, placebo recipients will be assigned to receive ORMD-0801 capsules once or twice a day for another 26 weeks, while ORMD-0801 recipients in the first round will continue taking the capsules once or twice a day as originally assigned.

The study team is looking primarily for changes in blood glucose levels, measured by the standard hemoglobin A1C test after 26 weeks, compared to the beginning of the trial. Researchers are also measuring fasting blood glucose levels, a screening test to detect type 2 diabetes after 26 weeks, compared to the start of the trial.

“ORMD-0801 is the first oral insulin capsule to achieve the requisite efficacy and safety data enabling us to run the world’s first FDA phase 3 oral insulin trial,” says Nadav Kidron, Oramed’s CEO in a company statement. Oramed says it’s planning a second late-stage trial of ORMD-0801 with 450 participants.

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