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New Oral Antidiabetic Agent May Offer Treatment Advantage for People with Type 2 Diabetes
Approximately 50 percent of the 17 million Americans who have been diagnosed with type 2 diabetes are currently required to take a combination of oral medications, along with their recommended diet and exercise program, in order to control their blood sugar. The results of two clinical trials show that a new oral combination pill, which targets multiple metabolic defects associated with type 2 diabetes, may offer an important treatment option for patients with this condition.
The results of these studies were presented today during the 62nd Annual Meeting and Scientific Sessions of the American Diabetes Association in San Francisco.The two studies evaluate a new oral agent that combines two leading antidiabetics -- glipizide and metformin -- in a single tablet. The study results show that the new glipizide/metformin tablet was more effective than single agent therapy with either metformin or glipizide, when used to treat patients with type 2 diabetes who did not have adequate glycemic control on diet and exercise alone, or on diet and exercise plus a sulfonylurea.
"Bristol-Myers Squibb has been a leader in developing therapies that offer a new and more aggressive approach to managing type 2 diabetes," said Peter R. Dolan, Chairman and Chief Executive Officer, Bristol-Myers Squibb. "The company's first oral combination pill, Glucovance (R) (Glyburide and Metformin HCl Tablets), has generated more than 6.5 million prescriptions since the product was launched in August 2000. The company's research to develop the glipizide/metformin tablet is the latest example of our ongoing commitment to provide new treatment options for patients with type 2 diabetes."
The "Glipizide/Metformin Tablets as First-Line Treatment in Type 2 Diabetes" study explored the use of the combination tablet in 868 patients with type 2 diabetes who are not able to adequately control their condition with diet and exercise alone. In the 24 week study, patients who were randomized to glipizide/metformin (n=329) experienced significant reductions in A1C, the standard measure of blood sugar control, from baseline compared with patients who received single agent metformin (n=171) or glipizide (n=168) therapy (p<0.001). In addition, a greater percentage of patients who received the glipizide/metformin tablet were able to achieve an A1C level of <7%, which is the treatment goal recommended by the American Diabetes Association (ADA).
The results of the "Glipizide/Metformin Tablets as Second-Line Therapy in Type 2 diabetes" study explored the use of the drug in 247 patients who were unable to achieve satisfactory blood sugar control with a sulfonylurea alone. After 18 weeks of therapy, patients who received the glipizide/metformin (n=80) combination showed significantly lower A1C levels than those who received single agent therapy with either metformin (n=71) or glipizide (n=79) (p<0.001).