Once an investigational drug passed its Phase III Clinical trials, it will most likely be approved by the FDA for marketing.

Aside from Novo Nordisk's Liraglutade (which has recently entered Phase III clinical trial), Elixir Pharmaceuticals, Inc.'s mitiglinide for the treatment of patients with type 2 diabetes have entered into its final, pivotal phase III clinical study.

In previous clinical studies, mitiglinide therapy has been shown to significantly lower patients' levels of HbA1c (hemoglobin A1c), the standard measure of glucose control.

In addition, mitiglinide has been shown to improve the body's own ability to produce insulin in a glucose-dependent manner at meal time, mimicking the natural glucose response by producing a rapid and brief burst of insulin when glucose levels begin to elevate.

Mitiglinide's efficacy and safety in type 2 diabetes is supported by three years of in-market use in Japan under the brand name Glufast®.

Glufast® is a late-stage product that has been acquired by Elixir from the Japanese company Kissei Pharmaceutical. (pdf file)

Mitiglinide (a member of the meglitinide class of compounds) has been studied extensively in human clinical studies in
the U.S., Europe, Australia, and Asia, whose results demonstrated an excellent safety and efficacy profile for mitiglinide.

According to John Whisnant, M.D., the Chairman of Elixir's Clinical Advisory Board:

"There continues to be a tremendous unmet medical need in the U.S. for therapeutics that can be used alone or in combination with other drugs to provide patients with type 2 diabetes with more complete glucose control throughout the day. If approved, mitiglinide could offer a new, versatile treatment option for patients who are not getting adequate glucose control with metformin therapy alone."

While type 2 diabetes continues to sweep the western world, the demand for better treatment will never stop. However, even if type 2 diabetes drugs are coming out of the market, we should remember that these drugs alone is not enough to manage and control type 2 diabetes. Lifestyle has a lot to do with that too, especially diet and exercise.

Source: Elixir Pharmaceuticals Inc. (a pdf file)