February 09, 2016

Landmark Type 2 diabetes study continues — volunteers still needed

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grade studyVolunteers with Type 2 diabetes are still needed for a continuing national study of 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.

The University of Alabama at Birmingham is one of 50 institutions across the nation participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, or GRADE study. GRADE is sponsored by the National Institutes of Health with a goal of enrolling 5,000 patients nationwide.

“The GRADE study is the first comparative effectiveness study which will look directly at the four major treatments for diabetes, compare them, and try to determine which one or ones are the best for treating Type 2 diabetes,” said Andrea L. Cherrington, M.D., associate professor of preventive medicine and co-primary investigator at UAB. “At present, there is little consensus on which combinations of the current diabetes drugs in conjunction with metformin will best serve different patient populations.”

Metformin is widely accepted as the first medication that should be used to treat Type 2 diabetes; however, most patients eventually require an additional medication to manage the disease. The results of GRADE will help doctors guide the management of individuals with Type 2 diabetes in the future and might provide more immediate benefits now to those who participate.

Phil Ferguson has been enrolled for more than a year. He knew his blood sugar levels had been rising over time, but he did not fully grasp the need to take control of his diabetes until he became involved in the study.

“The best part of this study has been the people conducting it,” Ferguson said. “They are informative and compassionate and really help you understand how diabetes affects you. I’m in a much better place now for having joined the GRADE study, and I’ll miss it when it wraps up in a few years.”

People with Type 2 diabetes may be eligible to join the GRADE study if they:

  • Have had Type 2 diabetes for less than 10 years
  • Are over 30 years old
  • Are American Indian and over 20 years old
  • Take only metformin (Glucophage®) for their diabetes
  • Are willing to take a second diabetes medication
  • Are willing to make four office visits per year for the next four to six years

Participants in the GRADE study will receive:

  • Close follow-up from an expert diabetes care team at no cost
  • Diabetes medications and supplies at no cost
  • Diabetes care visits and lab tests at no cost
  • Diabetes education at no cost

The GRADE study is looking to enroll a cross section of patients with Type 2 diabetes of any age, gender and ethnicity. The study will follow its participants for seven years and will provide free medications and diabetes care. Contact Dana Golson at 205-996-4015 or ccnrn@uab.edu for more information on enrolling in the study.

“It is estimated that nearly one in three children, and one in two minority children, born after the year 2000 will develop Type 2 diabetes,” said W. Timothy Garvey, M.D., professor and chair of the Department of Nutrition Sciences, director of the UAB Diabetes Research Center, and co-primary investigator at UAB. “Type 2 diabetes progresses gradually, and this study will help us understand how different combinations of medicines affect the disease and the people who are taking those medications over time.”

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 pre-diabetes.

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.

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