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 range
30 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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)
. More than 10 years of treatment with metformin at time of randomization screening
. History of intolerance or allergy or other contraindications to any of the proposed study medications
. Resides in the same household with another GRADE study participant
. Current need for any specific glucose-lowering medications solely for other conditions, for example for polycystic ovary syndrome
. Symptomatic hyperglycemia requiring immediate therapy during screening or run-in, in the judgment of the physician
. A life-threatening event within 30 days prior to screening or currently planned major surgery