Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study
The GRADE Study is a pragmatic, unmasked clinical trial that will compare commonly used diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and patient-centered outcomes.
• Men or women diagnosed with diabetes at age ≥ 30 years (≥ 20 for American Indians)
• Duration of diagnosed diabetes \< 10 years
• HbA1c criteria (at final run-in visit, \
⁃ 2 weeks prior to randomization): 6.8-8.5%
• Taking a daily dose of ≥ 1000 mg metformin for a minimum of 8 weeks at final run-in
• Willingness to administer daily subcutaneous injections, take a second diabetes drug after randomization, potentially initiate insulin and intensify insulin therapy if study metabolic goals are not met, perform self-monitoring of blood glucose
• Fluent in either English or Spanish
• A negative pregnancy test for all females of childbearing potential (i.e. pre-menopausal, and not surgically sterile)
• Provision of signed and dated informed consent prior to any study procedures