USA-based Generex Biotechnology has reached an enrollment milestone in its pivotal Phase III study of Oral-Lyn prandial oral insulin spray.
Over 200 subjects have now been enrolled in the trial at 74 sites in the USA, Canada, Bulgaria, Poland, Romania, Russia and the Ukraine. Up to 750 subjects with type 1 diabetes mellitus will be recruited to compare the efficacy of Oral-Lyn and Generex' RapidMist diabetes management system to prandial injections of regular human insulin.
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