Diabetes trial could have a big impact on treatment

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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 this month, 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," says William Tamborlane, MD, the principal investigator of the GRADE Center at Yale, which is one of 36 study sites.

Fair Haven Community Health Center in New Haven, which is collaborating on the study with Yale, is also recruiting volunteers. "We want to make sure that the study reflects the diversity of New Haven's community since diabetes disproportionately affects Hispanics and African-Americans," said Anne Camp, MD, Fair Haven's diabetes program director and a co-investigator in the study.

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," says Silvio Inzucchi, MD, director of the Yale Diabetes Center and co-investigator in the trial.

 

You can learn more about the study at grade.bsc.gwu.edu. 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.


This Article was submitted by Mark Santore, on Monday, December 02, 2013.
Source: Yale Medical Group