New Oral Insulin Shows Safety, Feasibility in Trials

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.

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.