UT Health Science Center, Texas Diabetes Institute among enrolling centers
SAN ANTONIO (April 17, 2014) — The first comprehensive, long-term study comparing different medications for type 2 diabetes is recruiting participants at The University of Texas Health Science Center at San Antonio and the University Health System’s Texas Diabetes Institute.
The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study 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.
Ralph DeFronzo, M.D., principal investigator of the UT Health Science Center and Texas Diabetes Institute study site, said GRADE will compare the effects of four glucose-lowering medications — a sulfonylurea called glimepiride; a DPP-4 inhibitor, sitagliptin; a GLP-1 agonist, liraglutide; and a basal insulin, glargine — when each is added to metformin.
“All of these medications currently are approved for the treatment of type 2 diabetes, but it yet has not been established which antidiabetic medication provides the best glycemic control in diabetic patients who are suboptimally controlled on metformin,” Dr. DeFronzo said. He is division chief of diabetes in the School of Medicine of the Health Science Center and deputy director of the Texas Diabetes Institute.
Five-thousand patients will be enrolled in up to 50 academic and VA medical centers nationwide, including 150 in San Antonio. Patient outcomes will be followed for up to seven years. Participants will have their diabetes medications managed free of charge throughout the study, including at least four medical visits per year.
At enrollment, participants must be:
• At least 30 years of age with a diagnosis of type 2 diabetes
• Within 10 years of time of diagnosis
• Taking metformin only
• Willing to take a diabetes medication in addition to metformin
To inquire about study eligibility, please call 210-358-7200.
The GRADE Study is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health. It is coordinated by the Biostatistics Center, a research facility of George Washington University.
Anyone interested in learning more about the study can visit www.gradestudy.org.
The GRADE Study (ClinicalTrials.gov number: NCT01794143) is supported under NIH grant U01DK098246.
Type 2 Diabetes in the U.S., Texas and Bexar County
Type 2 diabetes is an epidemic that threatens to become the century’s major public health problem and poses enormous human and economic challenges worldwide. Nearly 26 million Americans are affected by diabetes and 79 million have prediabetes.
Diabetes is a chronic disease that, when left untreated or not properly managed, can result in serious complications, including kidney failure, blindness, limb amputation and death. In 2012, 11.4 percent of Bexar County adults reported being diagnosed with diabetes, a rate similar to the state of Texas. (Source: 2013 Bexar County Community Health Assessment, Page 168)
Bexar County was home to 1,785,787 people in 2012, according to the U.S. Census Bureau, and 11.4 percent of this figure totaled 203,579. Thousands more individuals in the area lived with undiagnosed diabetes.
UT Medicine San Antonio is the clinical practice of the School of Medicine at the UT Health Science Center San Antonio. With more than 700 doctors – all School of Medicine faculty – UT Medicine is the largest medical practice in Central and South Texas. Expertise is in more than 100 medical specialties and subspecialties. Primary care doctors and specialists see patients in private practice at UT Medicine’s flagship clinical home, the Medical Arts & Research Center (MARC), located at 8300 Floyd Curl Drive, San Antonio 78229. Most major health plans are accepted, and UT Medicine physicians also practice at several local and regional hospitals. Call (210) 450-9000 to schedule an appointment, or visit www.UTMedicine.org for a list of clinics and phone numbers.