Clinical Trial 23773

St. Louis, MO 63110


Summary:

The GRADE study, a diabetes treatment study, is a long term research study designed to compare the effects of adding one of four different diabetes medications to the treatment program of patients who are already taking metformin. The four diabetes medications are recommended by the American Diabetes Association and approved by the FDA to treat type 2 diabetes. Each medication has advantages and disadvantages, but it is not clear which of the four is best for controlling diabetes over the long-term. The goal of GRADE is to try to answer that question.

The National Institutes of Diabetes and Digestive and Kidney Diseases, part of the NIH, in collaboration with 37 medical clinics, including Washington University School of Medicine, is conducting this study. During the first year there will be about 6 study visits after that there will be 4 visits each year for the next 4 to 7 years.

Participants receive physical exams, lab tests (blood draw, urine specimen), Oral Glucose Tolerance Test, memory tests, foot exam, diabetes education and healthy lifestyle guidance and questionnaires.

No charge to the participant or their insurance provider.

Parking is free and if the participant takes the Metro, fare will be reimbursed. A small travel stipend provided and a $100 payment at each yearly visit. Participant’s primary care doctor will be provided a copy of lab results and up-dates at specific study visits. The study staff will assume responsibility for diabetes medication management but the participant’s primary care doctor will remain responsible for all other care.


Qualified Participants Must:

• Have Type 2 Diabetes diagnosed within the past 10 years
• Be taking metformin and no other diabetes medications
• Have a current HbA1c greater than or equal to 6.8%


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.