Chewing gum format aims to win over diabetes sufferers

A chewing gum product developed by Generex Biotechnology to regulate blood glucose levels in diabetes type 2 patients is to be the subject of a clinical study.

The protocol for MetcontrolT, Generex's proprietary Metformin chewing gum product, is an open-label crossover study comparing Generex's Metformin chewing gum and immediate release tablets in healthy volunteers.

Metformin is a generic drug used to regulate blood glucose levels by reducing liver glucose production and improving insulin sensitivity by the cells. Through this action, Metformin allows the insulin produced by the body to be used more effectively and ultimately reduces the amount of glucose in the blood. Metformin is the backbone of all treatment for type 2 diabetes mellitus. Despite being the most prescribed drug for this condition, there are still millions who do not use it because of gastrointestinal side effects, large pill size and its bitter taste.

Developing a better tasting chewing gum format may make the drug more acceptable to such patients as the burgeoning population of children with type 2 diabetes, and may increase compliance with the therapy.

The r&d path that leads to commercialisation of this product is not anticipated to be as lengthy as a typical New Chemical Entity(NCE) as Metformin is not a new active compound. It is a well-established active that has been accepted globally for the treatment of patients with diabetes. "We are pleased to have completed this very key piece of the puzzle in the development of our Metformin gum product," said Anna Gluskin, the company's president and ceo. "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."

The company, which is based in Worcester, Massachusetts, is a leader in drug delivery for metabolic diseases through the inner lining of the mouth.