A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 … (NCT01794143) | Clinical Trial Compass
CompletedPhase 3
A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes
United States7,850 participantsStarted 2013-05
Plain-language summary
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.
Who can participate
Age range30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Suspected type 1 diabetes (lean with polyuria, polydipsia, and weight loss with little response to metformin) or "secondary" diabetes due to specific causes (e.g. previously diagnosed monogenic syndromes, pancreatic surgery, pancreatitis)
✕. Current or previous (within past 6 months) treatment with any diabetes drug/glucose-lowering medication other than metformin (limited use of no longer than seven days is allowed, for example during hospitalization)
✕
What they're measuring
1
Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication
Timeframe: Quarterly for 4 to 7 years
2
HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication