Combined Therapy Improved Care Of Patients With Type 2 Diabetes Proper Use Of New Oral Medications Evaluated

March 26, 1998

NEW HAVEN, Conn., March 26, 1998-When patients with type 2 diabetes took two new medications together, rather than separately, they experienced further improvement in controlling their blood glucose levels, according to a new study conducted by researchers at Yale University School of Medicine and the Howard Hughes Medical Institute at Yale.

"The medications that we studied-metformin and troglitazone-act in different ways in the human body and were equally effective in lowering patients' blood glucose levels," explains Gerald I. Shulman, M.D., Ph.D., professor of medicine (endocrinology) and of cellular and molecular physiology at Yale and an investigator with the Howard Hughes Medical Institute. "The combined therapy was logical and reversed two abnormalities that patients with this disorder experience. Metformin acted primarily to decrease the patients' liver glucose production, while troglitazone worked primarily to enhance the ability of the patients' muscle to respond to insulin and take up glucose."

The findings are reported in the March 26 issue of The New England Journal of Medicine, published by the Massachusetts Medical Society. The study itself was conducted in Yale's federally supported General Clinical Research Center. Glucose, a simple sugar, serves as an important source of energy in the human body, as well as an important source of energy for the brain. People with diabetes experience higher than normal blood glucose levels, which can lead to complications.

Type 2 diabetes, the most common type of diabetes, is considered to be the leading cause of blindness, renal failure and loss of limb, according to the American Diabetes Association (ADA). It also is the fourth leading cause of death. Approximately $85 billion a year are estimated to be spent on direct diabetes care.

Type 2 diabetes affects about 15 million Americans, the ADA estimates. Approximately seven million Americans have been diagnosed with this disease, and another eight million remain undiagnosed.

In the study, Yale and HHMI physicians, scientists and nurses evaluated the efficacy and physiologic effects of these two oral medications in 29 patients who suffer from type 2 diabetes, a chronic disease that requires individuals to be greatly involved in their own daily medical care. For three months, the patients were treated with only one medication, and then for an additional three months simultaneously with both medications. During the study, the patients were prescribed a diet designed to maintain their base-line body weight.

"The future of treatment in our type 2 diabetic patients will likely be combination therapy since no single agent will reverse all of the abnormalities seen in our diabetic patients," Dr. Shulman explains. "Therefore, it is essential that we understand the mechanism by which these novel oral medications lower patients' blood glucose. We then will be able to combine them in a rational fashion for effective treatment."

According to Silvio E. Inzucchi, M.D., assistant professor of medicine (endocrinology), results of this study offer new treatment options for our patients with type 2 diabetes.

Besides Drs. Inzucchi and Shulman, co-authors are David G. Maggs, M.D.; Geralyn R. Spollett, A.P.R.N.; Stephanie L. Page, R.N.; Frances S. Rife, R.N.; and Veronika Walton, B.A..

The study was supported, in part, by grants from the National Institute of Diabetes and Digestive and Kidney Diseases, a component of the National Institutes of Health, and Warner-Lambert Co., the parent company of Parke-Davis. Both Drs. Inzucchi and Shulman are consultants to Parke-Davis.
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