Generex Reports Preliminary Results of a Phase IIb Study of Oral-lyn

Generex Biotechnology has reported results of a preliminary Phase IIb clinical study of Oral-lyn, the company's proprietary oral insulin spray formulation.

The study showed, in a comparison of the postprandial glycemic control between the Oral-lyn regimen and injected regular human insulin, 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 for methodological consistency).

The primary objective of this open-label, single-center, active comparator trial was to equate the four-hour pharmacokinetic and glucodynamic profiles of (1) Oral-lyn, given in a split dose around meals (five puffs before and after the meal), and (2) injected regular human insulin (0.05 IU/kg), also provided, for methodological reasons, in a split dose before and after the meal.

The study involved 10 patients with Type 1 Diabetes Mellitus on multiple daily insulin injections. Patients received either (1) Oral-lyn as a dose split equally between two administrations immediately before and after a standardized meal, or (2) regular human insulin injected in a dose split equally between two administrations before and after the test meal.