Generex Biotechnology has finalized the protocol for MetcontrolT, the company's proprietary Metformin chewing gum product, and will be proceeding with applications to regulatory agencies for approval of the protocol for a clinical study.
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The protocol is an open-label crossover study comparing Generex’s Metformin chewing gum and immediate release tablets in healthy volunteers. The company anticipates that approximately 75 – 100 patients will participate in the study.
Metformin is a generic drug used to regulate blood glucose levels by reducing liver glucose production and improving insulin sensitivity by the cells. The delivery of Metformin in a good tasting chewing gum format may make the drug more acceptable to these patients and may increase compliance with the therapy.
Anna Gluskin, president and CEO of Generex, said: “The goal of the Metformin gum development is to provide an alternative method of drug delivery that will improve both safety profiles and therapeutic compliance.”
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