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news.Generex Biotechnology has reached the enrollment milestone of more than 200 subjects in the company's pivotal Phase III clinical trial of Generex Oral-lyn, its proprietary prandial oral insulin spray product.
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The Phase III study will involve up to 750 subjects with Type-1 diabetes mellitus. There are 74 sites in the US, Canada, Bulgaria, Poland, Romania, Russia and Ukraine actively screening and enrolling subjects.
The objective of this long-term 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.
The company believes that Generex Oral-lyn will offer a safe, simple, fast, effective, and pain-free alternative to prandial insulin injections, which will improve subject compliance with therapeutic regimes, thereby delaying the progress of diabetes and the onset of its myriad complications.
Generex Oral-lyn is presently approved for commercial sale in India and Ecuador.