With type 2 diabetes on the rise, Baylor College of Medicine is recruiting participants for a groundbreaking study funded by the National Institutes of Health to establish the benefits and risks of taking certain medications with metformin, the most commonly used medication for treating type 2 diabetes.
GRADE, which stands for Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, is recruiting adults diagnosed with type 2 diabetes in the past 10 years, and currently taking only metformin for glucose control. If metformin is not enough to normalize glucose levels in these patients, one of four drugs, all approved for use with metformin by the U.S. Food and Drug Administration, will be added to the treatment plan to lower glucose.
These four medications have been tested and shown to be effective in the short term. GRADE is the first long-term study to determine their effectiveness when combined with metformin. All participants will take metformin and a randomly assigned second medication. Over four to seven years, doctors will track the effects each combination has on patients to determine which one works best and has the fewest side effects. The goal of the study is to determine the optimal long-term treatment for type 2 diabetes in the future.
“This is the first ever comparative effectiveness trial for diabetes,” said Dr. Ashok Balasubramanyam, professor of medicine in the Section of Endocrinology, Diabetes and Metabolism at Baylor. “GRADE is a landmark study that will set the standard for effective treatment of type 2 diabetes.”
In addition to receiving the diabetes medications at no cost for the duration of the study, participants will receive specialized personal care from a diabetes expert. They also will receive compensation, as well as the appropriate laboratory tests, some supplies and nutritional counseling at no cost.
For more information or to participate in the study at Baylor College of Medicine, call 713-798-3625.
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.