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Yale Diabetes Center seeks participants for a high-impact trial

July 21, 2013

The Yale Diabetes Center is looking for volunteers to take part in a clinical study that physicians say could have a major impact on how the disease is treated. The Glycemia Reduction Approaches in Diabetes (GRADE) Study, which began in June, 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 type 2 diabetes.

“We have no doubt that GRADE will be one of the most important studies ever carried out regarding the treatment of type 2 diabetes, now and for the future,” said William Tamborlane, MD, the principal investigator of the GRADE Center at Yale, which is one of 36 study sites.

Eventually, most people treated with metformin need a second drug. The American Diabetes Association recommends four potential second-line treatments to lower blood sugar. But 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 GRADE study will compare drug effects on glucose levels, adverse effects, diabetes complications and quality of life over an average of nearly five years.

Investigators at Yale and 36 other study sites are seeking to enroll about 5,000 patients diagnosed with type 2 diabetes within the last five years. They 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 from among four classes of medications, all approved for use with metformin by the U.S. Food and Drug Administration.

Participants will receive their diabetes medications, laboratory tests, and diabetes medical visits free of charge through the study, but will receive other health care through their own providers. The study is being funded by the National Institutes of Health.

“One of the best parts of GRADE is that all the patients who enroll in the study will receive the most up-to-date treatments for their diabetes for up to seven years free of charge,” said Silvio Inzucchi, MD, director of the Yale Diabetes Center and co-investigator in the trial.

You can learn more about the study at To refer a patient at the Yale site, please call Patty Gatcomb, APRN, Yale’s GRADE Study coordinator at 203-764-8463 or Michele Alguard, Yale Recruitment Coordinator at 203-764-6649.

Submitted by Mark Santore on July 21, 2014