The study showed that Oral-lyn administered in a divided dose produces pharmacokinetic and glucodynamic profiles comparable to that produced by injected regular human insulin (administered in a divided dose).
The primary objective of this open-label, single-center, active comparator trial was to equate the four-hour pharmacokinetic and glucodynamic profiles of Oral-lyn, given in a split dose around meals, and injected regular human insulin, also provided, for methodological reasons, in a split dose before and after the meal.
Oral-lyn is predicted to carry less risk of hypoglycemia during chronic use than conventional injected insulin therapy. Generex is currently optimizing the Oral-lyn dosing regimen with a view to the implementation of pivotal clinical trials.
Unlike various pulmonary delivery methods, Oral-lyn is delivered as a fine spray to the buccal (oral) cavity via the company’s proprietary Rapidmist delivery system. The result is rapid insulin absorption through the buccal mucosal lining of the mouth without pulmonary (lung) exposure.