GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) approved Avandia (rosiglitazone maleate) for use in combination with insulin for the treatment of type 2 diabetes. Affecting more than 16 million Americans, type 2 diabetes is a serious disease that can progressively worsen over time, potentially causing serious complications, such as cardiovascular disease, kidney damage and blindness. As an adjunct to diet and exercise, Avandia now can be used in four therapeutic regimens: as monotherapy or as combination therapy with metformin, sulfonylureas or insulin to improve glycemic control in patients with type 2 diabetes.

"GlaxoSmithKline is very pleased with the new indication for Avandia," said David Pernock, Senior Vice President, General Pharmaceutical Business Unit at GlaxoSmithKline. "Clearly, people with type 2 diabetes need therapeutic options at each stage of their disease to help ensure tight glucose control. It is our hope that this new indication may help people to better manage their 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) generally start to fail over time and produce progressively 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 may result. To reach blood sugar levels recommended by experts, many people with type 2 diabetes may need to take a combination of therapies, possibly including the addition of insulin.

The approval of Avandia in combination with insulin was based upon data from four 26-week trials in patients with type 2 diabetes. Approximately 1,100 patients participated in clinical studies programs, which included two fixed-dose combination trials, one insulin reduction study and one study in patients with chronic kidney disease. The studies demonstrated the safety and efficacy of Avandia at 4 mg daily in combination with insulin. In fact, in patients receiving Avandia 4 mg daily plus insulin, there was a significant drop in blood sugar levels and approximately 40 percent of patients in the two fixed-dose trials were able to reduce their insulin dose.

Avandia is an insulin sensitizer that works by making the cells in the body more sensitive to its own natural insulin. Since the U.S. FDA approval of Avandia in May 1999, more than 22 million prescriptions have been written and more than three million patients have been treated in the United States.

Avandia, along with diet and exercise, helps improve blood sugar control. It may be prescribed alone, with metformin, sulfonylureas, or insulin. When taking Avandia with other hypoglycemic agents, like sulfonylureas or insulin, patients may be at risk for low blood sugar. Patients should ask their doctor whether they need to lower their sulfonylurea or insulin dosage.