GlaxoSmithKline announced that US FDA approved Avandamet (rosiglitazone maleate and metformin HCl) for use as initial treatment of type 2 diabetes as an adjunct to diet and exercise. Avandamet was previously approved as a second-line therapy - it was indicated for use in patients who were uncontrolled on metformin monotherapy. Now, with this recent approval, physicians can start their type 2 diabetes patients on Avandamet.

Avandamet is the only combination of a thiazolidinedione, rosiglitazone maleate (separately marketed as Avandia) and metformin HCl, with approved use as initial therapy of type 2 diabetes. Avandamet is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with dual rosiglitazone and metformin therapy is appropriate.

The announcement of the FDA approval for Avandamet for use as initial therapy in type 2 diabetes coincides with GlaxoSmithKline's announcement that its supply of Avandamet has been re-established.

"Many people with type 2 diabetes need to take more than one medication to treat the disease in different ways. The combination of rosiglitazone and metformin provides two complementary mechanisms of action," said Barry Goldstein, M.D., Ph.D., director, Division of Endocrinology, Diabetes and Metabolic Diseases, Jefferson Medical College of Thomas Jefferson University, Philadelphia. "Rosiglitazone targets insulin resistance, an underlying cause of type 2 diabetes, whereas metformin primarily works to reduce the amount of blood sugar (or glucose) produced by the liver. In fact, a clinical trial comparing Avandamet to both rosiglitazone alone and metformin alone showed that patients taking Avandamet achieved significantly lower blood sugar levels than with either monotherapy alone."

Nearly 18 million Americans have type 2 diabetes, the most common form of diabetes. Type 2 diabetes is characterized by high blood sugar levels that occur when the body does not produce enough insulin or does not respond properly to its own natural insulin, a condition called insulin resistance. To manage diabetes, it is important for patients to achieve the blood sugar goal set by their physicians. Blood sugar control is measured by the HbA1C test, or A1C, which reflects a person's average blood sugar levels over the previous two to three months. The American Association of Clinical Endocrinologistsrecommends an A1C of 6.5 per cent or lower. The American Diabetes Association recommends an A1C of less than 7%. Lowering blood sugar levels can help reduce the risk of diabetes-related complications, such as heart disease, stroke, blindness, loss of limbs and kidney disease.

"GlaxoSmithKline is committed to developing diabetes therapies to treat a disease that has reached epidemic proportions in the United States and throughout the world," said Anne M. Phillips, MD, vice president of Clinical for North America Cardiovascular-Metabolic, GlaxoSmithKline. "With the approval of Avandamet for use as initial therapy as an adjunct to diet and exercise, GSK offers this effective and convenient option now for initial treatment of type 2 diabetes. This combination of rosiglitazone and metformin can help patients get their blood sugar under control."