GRADE Study

 

Study Type
Diabetes/Prevention
Study Purpose
Pennington Biomedical is looking for individuals to participate in a Type 2 diabetes research study comparing the metabolic effects of four commonly used, FDA approved diabetes medications to maintain normal glucose levels.
About the Study

GRADE is funded by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health (NIH).  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.  Most people with diabetes eventually need 2 medications to control blood glucose levels. 

A major challenge is to determine which of the many possible drugs is the best choice among people already treated with metformin, the most commonly used diabetes drug.  GRADE will determine which combination of two medications is best for glycemic control, has the fewest side effects, and is the most beneficial for overall health.
Study Design

Number of visits:

  • 3-4 screening visits
  • Quarterly and annual outpatient visits until end of study

Study procedures:

  • Height, weight, vitals
  • Blood draws
  • Urine samples
  • Questionnaires
  • Memory testing
  • Foot exams
  • Oral Glucose Tolerance Test (OGTT)
  • Diabetes education

After completion of all screening visits, eligible participants will be randomly assigned to one of four treatment groups. These treatment groups consist of four commonly used, FDA approved diabetes medications (glimepiride, sitagliptin, liraglutide, and basal insulin glargine), plus metformin. Volunteers will be followed for up to 7 years to evaluate their relative effectiveness in achieving good glycemic control and on overall health. Volunteers will receive diabetes medications, diabetes education and all study related procedures at no cost.

Study Qualifications
  • Age: ≥ 30 years old (≥ 20 years for American Indians) at age of diabetes diagnosis
  • Diagnosed with Type 2 diabetes within the last 10 years
  • Currently taking only Metformin for Type 2 diabetes
  • HbA1c ≥ 6.8%
Study Duration
Multi-year
Compensation
Participants will be compensated up to $100/year of participation.
Study Contact
If you are interested in volunteering for the GRADE study, click here to screen online, call 225-763-3000 or email clinicaltrials@pbrc.edu.

If you think you may be eligible, please click the button below to screen online.



Please do not fill out this questionnaire for anyone other than yourself unless you are their legal guardian.
If you know someone who may be interested please direct them to the site or have them call us directly at 225-763-3000.

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