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Recruitment for long-term study of diabetes drug efficacy underway

Baylor College of Medicine is recruiting volunteers for a multi-site study funded by the National Institutes of Health 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.

If metformin is not enough to help manage type 2 diabetes in a patient, one of several other drugs to lower glucose (blood sugar) may be added to the treatment plan. 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 project, called the Glycemic Reduction Approaches in Diabetes: A comparative Effectiveness (GRADE) study, is recruiting adults diagnosed with type 2 diabetes within the past five years. They may be on metformin, but not on any other diabetes medication.

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, all approved for use with metformin by the U.S. Food and Drug Administration. 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.

For more information or to participate in the study at Baylor College of Medicine, please 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.