The six-month Phase III study will involve up to 750 patients with Type-1 diabetes mellitus in 36 centers located in the US, Canada, Russia and eastern Europe.
The objective of the study is to compare the efficacy of Generex Oral-lyn and the company’s RapidMist diabetes management system with prandial injections of regular human insulin as measured by HbA1c.
Generex Oral-lyn, a liquid formulation of human regular insulin, is sprayed into the mouth with a simple device similar to inhalers used for the treatment of asthma.
Philip Raskin, managing director of the University of Texas Southwestern Medical Center at Dallas, said: “Diabetes mellitus is an overwhelming worldwide problem. Many people do not achieve their treatment goals because of failure to use insulin. As a principal investigator, I am pleased to announce that the international Phase III non-inferiority study of 750 patients has dosed its first patient.”