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Positive Results Reported for Oral Insulin in Type-1 Diabetes

Capsules reduce exogenous insulin requirements in mid-stage trial

Positive clinical results have been reported from a phase IIa clinical study of oral insulin capsules (ORMD-0801, Oramed Pharmaceuticals) in patients with type -1 diabetes. The trial was conducted in the U.S. under an FDA investigational new drug (IND) protocol.

The prospective, randomized, double-blind, placebo-controlled study evaluated the safety of pre-meal ORMD-0801 and its effect on exogenous insulin requirements in 25 patients with established type-1 diabetes.

The study’s primary endpoint was the change from baseline in basal, bolus, and total exogenous insulin requirements in patients treated with ORMD-0801 compared with the change from baseline in those given placebo. The secondary endpoint was the change from baseline in mean nighttime, daytime, and fasting glucose levels (as determined by continuous glucose monitoring) in patients treated with ORMD-0801 compared with the change from baseline in the placebo group.

ORMD-0801 oral insulin given before meals appeared to be safe and well-tolerated for the dosing regimen used in the study. Consistent with the timing of administration, the data showed a decrease in rapid-acting insulin, a decrease in postprandial glucose, a decrease in daytime glucose (as determined by continual glucose monitoring), and an increase in post-prandial hypoglycemia in the active-treatment group.

Type-1 diabetes is an autoimmune disease in which pancreatic beta cells responsible for insulin secretion are attacked by the immune system. In the absence of endogenous insulin and concomitant glycemic control, extraneous insulin must be supplied to regain glycemic control and to prevent future disease complications, which can include heart disease, vascular disease, nerve and eye disease, infections, and hypoglycemic events.

According to the International Diabetes Federation, type-1 diabetes is on the rise at a rate of 3% per year and currently affects approximately 36 million people worldwide –– about 10% of the global diabetes population. Type-1 diabetes was formerly called juvenile diabetes, but it is now known to affect both pediatric and adult populations.

Source: Oramed Pharmaceuticals; October 22, 2014.

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