A study is currently being conducted in the US wherein the site is actively screening and enrolling subjects. The protocol for the study is an open-label, two-treatment, two-period, randomized, crossover study comparing MetControl and immediate release metformin tablets in healthy volunteers.
The study results will allow the company to proceed with additional R&D initiatives and consider regulatory agency registration applications.
Metformin is a generic drug used to regulate blood glucose levels by reducing liver glucose production and improving the insulin sensitivity of cells. Metformin is the backbone of almost all treatments for Type 2 diabetes mellitus.
Rose Perri, COO of Generex, said: “We are excited about the commencement of this study on our proprietary metformin gum product. We have high expectations for this product to enhance the company’s already growing diabetes product pipeline.”