Daiichi Sankyo, Inc. announced it has asked the U.S. Food and Drug Administration (FDA) to approve use of its cholesterol drug WelChol® (colesevelam HCl) as a diabetes drug for type 2 diabetics.

If approved, WelChol will be the first medication for lowering LDL (bad) cholesterol that is also approved for improving glycemic control. Clinical studies have shown that WelChol lowers A1C (a measure of blood glucose control) in patients with type 2 diabetes mellitus.

A study presented at the American Heart Association's (AHA) Scientific Sessions 2006 showed that WelChol, when added to insulin, demonstrated a mean A1C reduction of 0.5% compared to a placebo.

"Every physician who treats diabetes is looking to lower A1C as effectively as possible, resulting in a constant lookout for improved combinations of therapy," said Dr. Ronald B. Goldberg, Associate Director of the Diabetes Research Institute at the University of Miami.

"The same can be said for LDL-cholesterol as well," said Goldberg. "As a result, a compound that can help lower both of these important cardiovascular risk factors, A1C and LDL-cholesterol, can be of great benefit for many patients."

"Given the prevalence of type 2 diabetes and high cholesterol and the number of patients who are not reaching goal, adding WelChol expands patients' treatment options," said Joseph P. Pieroni, President and CEO of Daiichi Sankyo, Inc.