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news.Generex Biotechnology has received approval from the ethics committee at the University Campus Bio-Medico of Rome to conduct a Generex Oral-lyn trial with subjects diagnosed with or susceptible to developing impaired glucose tolerance.
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The endpoint of the study is to determine if glucose levels will drop when subjects use Generex Oral-lyn, the company’s proprietary oral insulin spray product, with the company’s proprietary RapidMist drug delivery device.
Generex Oral-lyn is presently approved for commercial sale in India and Ecuador as an oral insulin spray product. In addition, Generex Oral-lyn is in Phase III trials at 31 clinical trial sites in the US, Canada, Russia, and Ukraine. The trial involving impaired glucose tolerance subjects is for a separate indication than these Phase III trials and commercialization of the product.
The company has said that future studies in this therapeutic area will not only continue to evaluate product safety and efficacy but will also determine the subjects’s satisfaction to treat pre-diabetes with a non-invasive insulin product that compliments the regularly prescribed regimen of exercise and weight loss.