SUNY Downstate Health Sciences University Begins Recruitment for Long-term Study of Diabetes Drug Efficacy
Jun 3, 2013
Brooklyn, NY – SUNY Downstate Health Sciences University 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. Beginning recruitment in June, the project is called the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) 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 glucose (blood sugar). But while short-term studies have shown the efficacy 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 Barbara Linder, MD, PhD, the GRADE project officer at the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health. “This study will help us understand how different combinations of medications affect the disease over time, and ultimately help physicians make better choices for their patients’ long-term care.”
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. Investigators at SUNY Downstate Health Sciences University and 36 other study sites are seeking people diagnosed with type 2 diabetes within the last five years. They may be on metformin, but not on any other diabetes medication. During the study, all participants will take metformin, along with a second medication randomly assigned from among four classes of medications, all 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 free of charge through the study, 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. Dr. Nathan and John Lachin, ScD, of The George Washington University, Washington, DC, are co-principal investigators.
“In addition to determining which medications control blood glucose levels most effectively over time, we hope to examine individual factors that are associated with better or worse response to the different medications,” Dr. Nathan said. “This should provide understanding of how to personalize the treatment of diabetes.”
MaryAnn Banerji, MD, chief of endocrinology and director of the Diabetes Treatment Center at SUNY Downstate, said, “Type 2 diabetes is a major health problem in Brooklyn. The GRADE study should prove extremely valuable in helping us learn how to best treat and manage diabetes among Brooklyn residents.” For more information about the study at Downstate, please call 718-270-1542.
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.
Learn more about the study at https://grade.bsc.gwu.edu.
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About SUNY Downstate Health Sciences University
Downstate Health Sciences University in Brooklyn is one of four academic health centers (AMCs) in The State University of New York (SUNY) 64-campus system and the only SUNY AMC in New York City dedicated to health education, research, and patient care for the borough’s 2.7 million residents. Its flagship hospital, University Hospital at Downstate (UHD), is a teaching hospital and benefits from the expertise of Downstate’s exceptional medical school and world-class academic center research facilities. With a staff of over 800 physicians representing 53 specialties and subspecialties, Downstate offers comprehensive healthcare services to the community.
UHD provides high-risk neonatal and infant services, pediatric nephrology, and dialysis for kidney diseases and is the only kidney transplantation program in Brooklyn. Beyond its clinical expertise, Downstate houses a range of esteemed educational institutions, including its College of Medicine, College of Nursing, School of Health Professions, School of Graduate Studies, and School of Public Health. Downstate fosters innovation through its multifaceted biotechnology initiative, the Biotechnology Incubator and BioBAT, which support early-stage and more mature biotech companies.