Emory and Atlanta VA join major new NIH diabetes study

Woodruff Health Sciences Center | June 5, 2013

Contact

Jennifer Johnson McEwen
(media inquiries only)
404-727-5696
jennifer.johnson@emory.edu

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37 Clinical Centers in the United States will enroll participants with type 2 diabetes within five years of diagnosis. View an interactive map of centers.

Emory University and the Atlanta Veterans Affairs (VA) Medical Center are participating in a new National of Institutes of Health (NIH) study to compare the long-term benefits and risks of four widely used type 2 diabetes drugs in combination with metformin, the first-line medication used to treat the common condition.

If metformin is not enough to help manage type 2 diabetes, a person’s doctor may add one of several other drugs to lower glucose (blood sugar). All of these drugs have been shown to lower glucose levels in short-term studies. However, there have been no long-term studies to determine which combination works best and has the least side effects.

The NIH project, called the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study, will compare drug effects on glucose levels, adverse effects, diabetes complications and quality of life over an average of nearly five years in patients at 37 sites across the United States.

Lawrence S. Phillips, MD, a professor in the division of endocrinology at Emory University School of Medicine, will serve as the lead investigator of the GRADE project at the Atlanta VA.  "This is a unique project that will allow us to compare the benefits and risks of these commonly used drugs, head-to-head, over a substantial period of time," says Phillips, a longtime diabetes physician and researcher at Emory and the Atlanta VA.

"The ultimate goal of the study is to get critical information that will help physicians offer accurate and personalized treatment options to their patients," adds Phillips.

GRADE aims to enroll about 5,000 patients nationwide and 150 patients at the Atlanta VA site diagnosed with type 2 diabetes within the last five years. They must be taking metformin, but not using any other diabetes medication. During the study, all participants will take metformin, along with a second medication randomly assigned from among four commonly used classes of medications, all approved for use with metformin by the U.S. Food and Drug Administration.

The medications include glimepiride, a sulfonylurea; sitagliptin, a DPP-4 inhibitor; liraglutide, a GLP-1 agonist; and glargine, a long-acting insulin.

Participants will have their diabetes medications managed free of charge through the study, including at least four medical visits per year, but will receive other health care through their own providers.

Barbara Linder, MD, PhD, of the National Institute of Diabetes and Digestive and Kidney Diseases, part of the NIH, is the project officer for GRADE.  David M. Nathan, MD, of Massachusetts General Hospital, and John Lachin, ScD, of The George Washington University, are co-principal investigators.

GRADE (ClinicalTrials.gov number: NCT01794143) is supported under NIH grant U01DK098246. Additional support in the form of donation of supplies comes from the National Diabetes Education Program, Sanofi-Aventis, Bristol-Myers Squibb, Novo Nordisk, Merck, BD Medical and Roche Diagnostics.

To learn more about the GRADE study at the Atlanta VA, please call 404 235-3024. For general information, please visit: https://grade.bsc.gwu.edu.