Baylor Endocrine Center is looking for volunteers to take part in a study to compare the long-term benefits and risks of four widely used diabetes drugs in combination with metformin, the most common first-line medication for treating type 2 diabetes. The project is called the GRADE: Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study.
If metformin is not enough to help manage type 2 diabetes, a person’s doctor may add one of several other drugs to lower blood sugar. But while short-term studies have shown the effectiveness of different drugs when used with metformin, there have been no long-term studies of which combination works best and has fewer side effects.
“Type 2 diabetes progresses slowly over a long period of time,” said Priscilla Hollander, MD, PhD, of Baylor Research Institute, principal investigator for the GRADE study.
The study will compare drug effects on glucose levels, adverse effects, diabetes complications and quality of life over an average of nearly five years.
GRADE aims to enroll about 5,000 patients around the country. Investigators at Baylor Endocrine Center and 36 other study sites are seeking people diagnosed with type 2 diabetes within the past five years. They may be taking metformin but not any other diabetes medications. During the study, all participants will take metformin along with a second medication randomly assigned from among four classes of medications approved for use with metformin by the U.S. Food and Drug Administration.
Three of the classes of medications increase insulin levels. They are: sulfonylurea, which increases insulin levels directly; DPP-4 inhibitor, which indirectly increases insulin levels by increasing the effect of a naturally occurring intestinal hormone; and GLP-1 agonist, which increases the amount of insulin released in response to nutrients. The fourth type of medication is a long-acting insulin.
Participants will have their diabetes medications managed through the study free of charge, including at least four medical visits per year, but will receive other health care through their own providers.
“What differentiates GRADE from previous studies is that it will perform a head-to-head, comprehensive comparison of the most commonly used drugs over a long period of time,” said David M. Nathan, MD, of Massachusetts General Hospital, Boston. Nathan and John Lachin, ScD, of The George Washington University, Washington, D.C., are co-principal investigators nationally.
Barbara Linder, MD, PhD, of the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health, is the project officer for GRADE.
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-Meyers Squibb, Novo Nordisk, Merck, BD Medical and Roche Diagnostics.
Learn more about the study at https://grade.bsc.gwu.edu .
Contact:
Kristine Hughes
kristine.hughes@baylorhealth.edu
214.820.7556
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