Can You Help With A Long-Term Study of Diabetes Drug Efficacy?
Pennington Biomedical Research Center 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.
Doctors say if Metformin is not enough to help manage type 2 diabetes, a person's doctor may add other drugs to lower blood sugar. There have been short-term studies, but not long-term studies of which combination works best and has fewer side effects.
The National Institutes of Health (NIH)-funded study will run five years for patients.
William Cefalu, M.D., principal investigator of the Pennington Biomedical site says,
"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 will try to enroll about 5,000 patients from across the United States. You must be 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 drug all approved by the Food and Drug Administration.
Participants will have their diabetes medications managed free of charge through the study.
David M. Nathan, M.D., of Massachusetts General Hosptial, Boston, says, "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". 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.
Dr. Cefalu says,
"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".
You can learn more about the study at https://grade.bsc.gwu.edu. To determine eligibility, call 225-763-3000 or visit www.pbrc.edu/GRADE.