Generex Biotechnology Corporation announced the commencement of a Phase II-B trial in Canad of Oralin, the company's proprietary oral insulin spray formulation.

This study is a randomized, 1:1, double blind, 90 day study in 80 Type 2 diabetic patients (male or female) with poorly controlled blood glucose who at entry to the study are maintained on one or two injections of insulin plus one or more oral anti-hyperglycemic agents.

The objective of the study is to determine the metabolic effect of Oralin under the company's proprietary RapidMist Diabetes Management System, which is designed to provide a pain-free, needle-free, convenient method of administering insulin via a liquid pharmaceutical formulation, delivered accurately into the mouth of the patient in the form of a spray.

The company's primary hypothesis is that Oralin can be used safely in combination with bedtime s.c. glargine and will maintain or improve glucose profiles, fructosamine and baseline hemoglobin levels during the study period.