GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) approved Avandamet (rosiglitazone maleate and metformin HCl) for the treatment of type 2 diabetes, offering an exciting new option for millions of Americans with the disease. Avandamet combines two leading diabetes medications in one convenient pill. This combination offers the opportunity to help people manage their type 2 diabetes longer. Avandamet will be available to patients in approximately one month.

"The combination of rosiglitazone and metformin provides two different, yet complementary mechanisms of action to manage diabetes," said Barry Goldstein, 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 works to reduce the amount of blood sugar (or glucose) produced by the liver. The two medications, when used in combination, target core metabolic defects to help achieve better blood sugar control than metformin alone, making this an important option for patients with type 2 diabetes."

Type 2 diabetes is characterized by high blood sugar levels that occur when the body cannot make enough insulin and/or respond normally to the natural insulin it makes (a condition called insulin resistance). In patients with type 2 diabetes, beta cells (the cells that make and release insulin in the pancreas) may become overworked and eventually fail, producing less insulin. This may lead to increased blood sugar levels and progressive worsening of the disease. When blood sugar levels are elevated over an extended period of time, serious complications can result, including cardiovascular disease, kidney damage and blindness. To reach blood sugar levels recommended by experts, many people with type 2 diabetes will need to take a combination of therapies that treat the disease in different ways.

The use of rosiglitazone and metformin together as separate tablets was first approved by the FDA in 1999 as safe and effective based on two controlled clinical trials in people with type 2 diabetes inadequately controlled on metformin alone. As an adjunct to diet and exercise, Avandamet is indicated to improve blood sugar control in people with type 2 diabetes who are already treated with rosiglitazone and metformin as separate tablets, or who are not adequately controlled on metformin alone. It is available in three tablet strengths of rosiglitazone/metformin, respectively: 1 mg/500 mg, 2 mg/500 mg and 4 mg/500 mg. The additive effect of the combination of rosiglitazone and metformin has been shown to significantly reduce A1C levels compared to metformin alone. A1C levels are the most effective measure of long-term blood sugar control. Additionally, it has been shown to successfully impact core defects of type 2 diabetes, resulting in improvements in both insulin resistance and estimates of beta-cell function.

In fact, research has demonstrated that rosiglitazone and metformin in combination significantly reduces and maintains blood sugar levels for up to two years. The combination has been associated with a low risk of hypoglycemia (low blood sugar). Avandamet, as a two-in-one therapy, is the most economical thiazolidinedione (TZD) combination on the market, offering simplified dosing.