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.”