INDIANAPOLIS — Indiana University School of Medicine is one of the 37 sites selected by the National Institutes of Health for a study of the long-term risks and benefits of four widely used diabetes drugs used in combination with metformin, the most common first-line medication for treating type 2 diabetes.
Enrollment in GRADE, or the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, by the IU Division of Endocrinology began in June. For additional information or to enroll in the study at IU, contact GRADE study coordinator Tonya Hamilton at 317-274-7679 or email@example.com.
“GRADE will answer a key question about what medicines should be used after initial therapy with metformin to treat diabetes,” said Kieren J. Mather, M.D., professor of medicine at the IU School of Medicine and principal investigator of the IU arm of the study. “We are using agents that are already used around the world, trying to see if one combination is better than the others in keeping glucose levels low. Participating in the study benefits people with diabetes now and in the future.”
When metformin is not enough to manage type 2 diabetes, a patient’s physician may add one of several other drugs to lower glucose (blood sugar). Short-term studies have looked at the effectiveness of different drugs used in combination with metformin; but no longer-term studies have evaluated which combination works best with the fewest side effects.
GRADE will compare drug effects on glucose levels, adverse effects, diabetes complications and quality of life over an average of five years. The overall study aims to enroll about 5,000 patients who have been diagnosed with type 2 diabetes within the past five years.
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.
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.