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UTHSC Begins Recruitment for Diabetes Medication Efficacy Study


UTHSC study to compare long-term benefits and risks of four widely used diabetes drugs

Memphis, Tenn. (June 3, 2013) – The University of Tennessee Health Science Center
(UTHSC) is looking for volunteers to take part in a study to 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. Beginning
recruitment in June, the project is called the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) 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 glucose (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 study will compare drug effects on glucose levels, adverse effects, diabetes
complications and quality of life over an average of nearly five years.

“Of the nearly 26 million Americans with diabetes, greater than 90 percent have type
2 diabetes,” said Samuel Dagogo-Jack, MD, FRCP, A.C. Mullins Professor who directs both the Division of Endocrinology, Diabetes and Metabolism and
Clinical Research Center at UTHSC. “Although diet and exercise are key components of the management of type 2 diabetes, most patients require the
addition of medications to control blood sugar levels. It would come as a surprise to the public that most of the approved medications for the
treatment of type 2 diabetes have not been tested head-to-head with regard to their effects on blood sugar lowering, tolerability, and adverse
effects. The new federally sponsored GRADE study will literally grade the major classes of current diabetes medications on their effectiveness in
maintaining good blood sugar control as well as other critical aspects. The Division of Endocrinology, Diabetes and Metabolism in the Department
of Medicine at UTHSC has successfully attracted every landmark diabetes research study sponsored by the National Institutes of Health. We are delighted
to continue this tradition and track record by serving as one of the sites for the multicenter, national GRADE study.”

GRADE aims to enroll about 5,000 patients. Investigators at UTHSC and 36 other
study sites are seeking people 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 have their diabetes medications managed at no cost through the
study, including at least four medical visits per year, but will receive other health care through their own providers.

As planned, the UTHSC site will enroll 150 participants with type 2 diabetes in the
GRADE study. To learn more about this study, call the University of Tennessee Clinical Research Center at (901) 516-2212.

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

For more information about this study, visit https://grade.bsc.gwu.edu.

As Tennessee’s only public, statewide academic health system, the mission of the University of Tennessee Health Science Center (UTHSC) is to bring the benefits of the health sciences to the achievement and
maintenance of human health, with a focus on the citizens of Tennessee and the region, by pursuing an integrated program of education, research,
clinical care, and public service. Offering abroad range ofpostgraduate andselected baccalaureatetraining opportunities, the
mainUTHSC campus is located in Memphis and includes six colleges: Allied Health Sciences, Dentistry, Graduate Health Sciences, Medicine, Nursing
and Pharmacy. UTHSC also educates and trains cohorts of medicine, pharmacy and/or allied health students — in addition to medical residents and
fellows — at its majorsites in Knoxville, Chattanooga and Nashville. Founded in 1911, during its more than 100 years, UT Health Science
Center has educated and trained more than 56,000 health care professionals in academic settings and health care facilities across the state. For
more information, visit www.uthsc.edu.