A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes



Status:Active, not recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:30 - Any
Updated:6/15/2018
Start Date:May 2013

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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.


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
We found this trial at
36
sites
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: William Tamborlane
Phone: 203-764-8463
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Timothy Garvey
Phone: 205-996-4015
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Deborah Wexler
Phone: 617-724-7851
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Boston, MA
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Ashok Balasubramanyam
Phone: 713-798-3625
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: William Sivitz
Phone: 319-384-5369
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Elizabeth Seaquist
Phone: 612-626-0143
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-936-1075
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Andrew Ahmann
Phone: 503-494-4650
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Albuquerque, New Mexico
Principal Investigator: David Schade
Phone: 505-272-5454
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: William Herman
Phone: 855-566-6559
University of Michigan The University of Michigan was founded in 1817 as one of the...
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6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
Principal Investigator: William Cefalu
Phone: 225-763-3000
Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
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1300 Morris Park Ave
Bronx, New York 10461
(718) 430-2000
Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
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Brooklyn, New York
Principal Investigator: Mary Ann Benerji
Phone: 718-270-4693
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Robert Cohen
Phone: 513-861-3100
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cleveland, Ohio 44106
Principal Investigator: Faramarz Ismail-Beigi
Phone: 216-231-3240
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Philip Raskin
Phone: 214-648-4561
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, Texas 75246
Principal Investigator: Priscilla Hollander
Phone: 214-820-4774
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Decatur, Georgia 30033
Principal Investigator: Lawrence Phillips
Phone: 404-235-3024
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Denver, Colorado 80210
Principal Investigator: Neda Rasouli
Phone: 303-399-8020
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Duluth, Georgia
Principal Investigator: Joshua Barzilay
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Jennifer Green
Phone: 919-681-3574
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, North Carolina 27703
Principal Investigator: Sue Kirkman
Phone: 984-974-3003
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Honolulu, Hawaii
Principal Investigator: Helen Petrovitch
Phone: 808-564-5700
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Hyattsville, Maryland 20782
Principal Investigator: Vanita Aroda
Phone: 301-560-2915
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Kieren Mather
Phone: 317-274-7679
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Miami, Florida
Principal Investigator: Hermes Flores
Phone: 305-575-7290
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Minneapolis, Minnesota 55416
Principal Investigator: Richard Bergenstal
Phone: 952-993-9605
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New York, New York
Principal Investigator: Robin Goland
Phone: 212-851-5489
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New York, New York
Principal Investigator: Xavier Pi-Sunyer
Phone: 212-523-4171
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Omaha, Nebraska 68198
Principal Investigator: Cyrus Desouza
Phone: 402-559-6244
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Phoenix, Arizona
Principal Investigator: Jonathan Krakoff
Phone: 602-200-5337
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Portland, Oregon 97227
Principal Investigator: Stephen Fortman
Phone: 503-571-3802
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Antonio, Texas 78229
Principal Investigator: Ralph DeFronzo
Phone: 210-358-7200
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San Diego, California
Principal Investigator: Robert Henry
Phone: 858-552-8585
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Seattle, Washington
Principal Investigator: Kristina Utzschneider
Phone: 206-227-4013
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