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Massive study reveals best diabetes drug combinations

NCT ID NCT01794143

Disease control Sponsor: GRADE Study Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared several common diabetes medications when added to metformin in 7,850 adults with type 2 diabetes. The goal was to see which combination best kept blood sugar under control over time. Results help doctors and patients choose the most effective treatment plan.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

7,850 people

The number who actually took part.

Start date

May 2013

Finished

Apr 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men or women diagnosed with diabetes at age ≥ 30 years (≥ 20 for American Indians) 2. Duration of diagnosed diabetes \< 10 years 3. HbA1c criteria (at final run-in visit, \~2 weeks prior to randomization): 6.8-8.5% 4. Taking a daily dose of ≥ 1000 mg metformin for a minimum of 8 weeks at final run-in 5. 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 6. Fluent in either English or Spanish 7. A negative pregnancy test for all females of childbearing potential (i.e. pre-menopausal, and not surgically sterile) 8. Provision of signed and dated informed consent prior to any study procedures Exclusion Criteria: 1. 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) 2. 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) 3. More than 10 years of treatment with metformin at time of randomization screening 4. History of intolerance or allergy or other contraindications to any of the proposed study medications 5. Resides in the same household with another GRADE study participant 6. Current need for any specific glucose-lowering medications solely for other conditions, for example for polycystic ovary syndrome 7. Symptomatic hyperglycemia requiring immediate therapy during screening or run-in, in the judgment of the physician 8. A life-threatening event within 30 days prior to screening or currently planned major surgery 9. Any major cardiovascular event in previous year, including history of myocardial infarction, stroke, or vascular procedure such as coronary artery or peripheral bypass grafting, stent placements (peripheral or coronary) or angioplasty. 10. Plans for pregnancy during the course of the study for women of child-bearing potential 11. History of or planning bariatric surgery, including banding procedures or surgical gastric and/or intestinal bypass (if banding removed, may be considered eligible after 1 year) 12. History of congestive heart failure (NYHA 3 or greater) 13. History of pancreatitis 14. History of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years prior to randomization 15. Personal or family history of MEN-2 or family history of medullary thyroid cancer 16. Estimated GFR (eGFR) \<30 ml/min/1.73 m2 or end stage renal disease requiring renal replacement therapy 17. History of severe liver disease or acute hepatitis or ALT \> 3 times upper limit of normal 18. Current alcoholism or excessive alcohol intake 19. Previous organ transplant 20. Treatment with oral or systemic glucocorticoids (other than short-term treatment, for example for poison ivy) or disease likely to require periodic or regular glucocorticoid therapy (inhaled steroids are allowed) 21. Treatment with atypical antipsychotics 22. History of hemolytic anemia, chronic transfusion requirement, or other condition rendering HbA1c results unreliable as indicator of chronic glucose levels, or hematocrit \<35 for males and \<33 for females 23. Clinically or medically unstable with expected survival \<1 year 24. Unwillingness to permit sites to contact the PCP to communicate information about the study and the participant's data 25. No non-study PCP or inability to identify such a PCP (who will provide non-study care) by the time of final run-in 26. Participation in another interventional clinical trial 27. Previous randomization in the GRADE study 28. In the opinion of the principal investigator (PI), any other factor, including language barrier, likely to limit compliance with the protocol

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Comparative effectiveness of glycemia-lowering medications Type 2 diabetes

Contacts and locations

Locations

  • Albert Einstein College of Medicine

    The Bronx, New York, United States

  • Atlanta VA Medical Center

    Decatur, Georgia, United States

  • Baylor College of Medicine

    Houston, Texas, United States

  • Baylor Endocrine Center

    Dallas, Texas, United States

  • Case Western Reserve University School of Medicine

    Cleveland, Ohio, United States

  • Columbia University Naomi Berrie Diabetes Center

    New York, New York, United States

  • Duke University Medical Center

    Durham, North Carolina, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, United States

  • International Diabetes Center

    Minneapolis, Minnesota, United States

  • Kaiser Permanente Northwest

    Portland, Oregon, United States

  • Kaiser Permanente of Georgia

    Duluth, Georgia, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

  • MedStar Health Research Institute

    Hyattsville, Maryland, United States

  • Mount Sinai St. Luke's Hospital

    New York, New York, United States

  • Oregon Health and Science University

    Portland, Oregon, United States

  • Pacific Health Research and Education Institute (VA Pacific Islands)

    Honolulu, Hawaii, United States

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, United States

  • Seattle Institute for Biomedical and Clinical Research

    Seattle, Washington, United States

  • South Florida VA Foundation (Miami VA)

    Miami, Florida, United States

  • Southwestern American Indian Center

    Phoenix, Arizona, United States

  • State University of New York (SUNY)-Downstate Medical Center

    Brooklyn, New York, United States

  • University of Alabama-Birmingham

    Birmingham, Alabama, United States

  • University of Cincinnati

    Cincinnati, Ohio, United States

  • University of Colorado

    Denver, Colorado, United States

  • University of Iowa

    Iowa City, Iowa, United States

  • University of Michigan

    Ann Arbor, Michigan, United States

  • University of Minnesota

    Minneapolis, Minnesota, United States

  • University of Nebraska

    Omaha, Nebraska, United States

  • University of New Mexico School of Medicine

    Albuquerque, New Mexico, United States

  • University of North Carolina Diabetes Care Center

    Durham, North Carolina, United States

  • University of Texas Health Science Center

    San Antonio, Texas, United States

  • University of Texas-Southwestern Medical Center

    Dallas, Texas, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, United States

  • Veterans Medical Research Foundation, San Diego (San Diego VA)

    San Diego, California, United States

  • Washington University School of Medicine

    St Louis, Missouri, United States

  • Yale University School of Medicine

    New Haven, Connecticut, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.