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New Oral Insulin Shows Safety, Feasibility in Trials

Posted: Thursday, June 15, 2006

In the first human trials of oral insulin, the drug acted within 15 minutes and showed 60%-70% of the biopotency of injected insulin, without causing any adverse effects, researchers reported here at the 66th Scientific Sessions of the American Diabetes Association.

Intesulin (Coremed, Inc., Lake Bluff, Illinois) is a long-acting, unmodified, regular insulin. In a dose-response evaluation involving four fasting type 2 diabetics, Dr. Frank K. Leung of Coremed and colleagues administered the product orally at 0.33 mg/kg or 0.67 mg/kg in a gel capsule, or injected Aspart insulin in a dose of 0.1 U/kg subcutaneously.

The study consisted of three periods followed by washout periods. Blood glucose was measured a total of 10 times over an 8-hour period in each phase.

Dr. Leung told meeting attendees that Intesulin steadily decreased blood glucose, with peak effects seen at 6 hours after dosing and with efficacy sustained throughout the rest of the eight-hour observation period. Blood glucose levels were between 70%-72% of baseline at peak in the oral insulin phase compared with 60% of baseline with injected insulin and 77% with placebo.

There was a trend toward better efficacy with the lower dose of oral insulin. There were no adverse events, episodes of hypoglycemia or gastrointestinal upset with oral insulin.

Source: Diabetes In Control: Presented at the 66th annual Scientific Sessions of the American Diabetes Association: Abstract 1976-PO FRANK K. LEUNG, JING LI, YIRONG SONG, EMILY LEUNG, SHAO LIN SU, XIAODI GUO.