The Baylor Endocrine Center is comparing 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 GRADE: Glycemia Reduction Approaches in Diabetes, A Comparative Effectiveness 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 blood sugar. But while short-term studies have shown the effectiveness of different drugs when used with metformin, there have been no long-term studies of which combination works best and has the fewest side effects.
“Type 2 diabetes progresses slowly over a long period,” said Priscilla Hollander, MD, PhD, of Baylor Research Institute, principal investigator for the GRADE study at Baylor.
The study will compare drug effects on glucose levels, adverse effects, diabetes complications and quality of life over an average of nearly five years.
During the study, all participants will take metformin along with a second medication randomly assigned from among four classes of medications approved for use with metformin by the U.S. Food and Drug Administration.
Four of the classes of medications increase insulin levels 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
- 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 through the study free of charge, including at least four medical visits per year, but will receive other health care through their own providers.
Diabetics who have blood sugar that isn’t well controlled on metformin alone might want to consider participating in the GRADE study at the Baylor Endocrine Center.
GRADE (ClinicalTrials.gov number: NCT01794143) is supported under NIH grant U01DK098246. Additional support in the form of the donation of supplies comes from the National Diabetes Education Program, Sanofi-Aventis, Bristol-Meyers Squibb, Novo Nordisk, Merck, BD Medical and Roche Diagnostics.
Learn more about the GRADE study on the website.