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Clinical Trial to Evaluate Type 2 Diabetes Treatments

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A clinical trial coordinated by George Washington University in Washington, D.C. will test the effectiveness of glucose-lowering drugs in treating type 2 diabetes. The five year, $134 million study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at National Institute of Health.

John Lachin, professor of biostatistics, epidemiology and statistics at GWU is the co-principal investigator on the project, with David Nathan, director of the Diabetes Center at the Massachusetts General Hospital and professor of medicine at Harvard Medical School in Boston serving as the study chair.  Lachin is currently interim director of GWU’s Biostatistics Center.

The trial — known as the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study — aims to better understand the relative effectiveness of different medications to treat type 2 diabetes. NIDDK calls type 2 diabetes an epidemic that threatens to become the major public health problem of this century. The agency cites estimates of some 24.5 million persons with type 2 diabetes in the U.S., with 1.8 million new cases added per year.

Health care practitioners need to find the proper level of glycemic (blood sugar) control in diabetes patients from the outset and then maintain those levels over time. There are few head-to-head comparative studies of different glucose-lowering medications, says NIDDK, either alone or in combinations, as well as studies of long-term effects of interventions on glycemic control.

“GRADE’s primary objective,” says Lachin, “is a direct comparison of the commonly used drugs over a more realistic period of time with regard to glucose lowering, side effects, tolerability, other effects and costs.” The study aims to enroll at 40 sites up to 7,500 patients with recently diagnosed type 2 diabetes over three years. GWU is recruiting clinical researchers with experience in type 2 diabetes trials to take part.

The trial will test the benefits of several anti-diabetic medications, with different glucose lowering mechanisms, when used in conjunction with metformin that decreases the amount of glucose absorbed from food and amount of glucose made by the liver, as well as increasing the body’s response to insulin. Metformin is an accepted first-line medication for treatment of type 2 diabetes. The study also plans to evaluate two treatment strategies — introducing combination therapy early in the course of diabetes care, and introducing combination therapy sequentially, considered the traditional treatment strategy.

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