Pennington Biomedical begins recruitment for long-term study of diabetes drug efficacy
POSTED: Tuesday, June 4, 2013 - 4:00am
UPDATED: Tuesday, June 4, 2013 - 12:54pm
BATON ROUGE, LA — Pennington Biomedical Research Center announced today that it is recruiting volunteers for a new clinical study that will 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 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.
The National Institutes of Health (NIH)-funded study will compare drug effects on glucose levels, adverse effects, diabetes complications and quality of life over an average of nearly five years.
William Cefalu, M.D., principal investigator of the Pennington Biomedical site stated, "The GRADE Study, by comparing all the currently available medications in a 'real world' setting, will determine the best combination of therapies for each individual. This is a highly translational research project as it is conducted at the community level. Given the progressive nature of type 2 diabetes, it is important that providers who care for those patients advance therapy as required in order to maintain effective blood sugar control that is necessary to reduce the complications of diabetes including eye, kidney, nerve and heart disease. Thus, a combination of oral and injectable therapies is needed."
GRADE aims to enroll about 5,000 patients from across the United States, with 150 patients coming from Baton Rouge and the surrounding area. Investigators at Pennington Biomedical and 36 other study sites are seeking people diagnosed with type 2 diabetes within the last five years. They must be at least 30 years of age and 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, M.D., of Massachusetts General Hospital, Boston. Nathan and John Lachin, Sc.D., of The George Washington University, Washington, D.C, are co-principal investigators.
In addition to Cefalu, Nathan and Lachin, Barbara Linder, M.D., Ph.D., of the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health, is the project officer for GRADE.
"Pennington Biomedical, since its inception, has conducted many NIH-funded landmark studies in the areas of diabetes, nutrition and obesity. The GRADE study is one of the largest ever proposed for management of type 2 diabetes. The fact that Pennington Biomedical was able to once again attract and obtain this type of high profile and important study reflects the high opinion the NIH has for the Center's facilities, staff and expertise," said Dr. Cefalu.
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.