Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:3 - Any
Updated:3/1/2019
Start Date:August 15, 2018
End Date:August 2024
Contact:Lisa Rafkin
Email:lrafkin@miami.edu
Phone:305-243-6146

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Hydroxychloroquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At-risk for Type 1 Diabetes Mellitus (T1D)

The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled
clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for
progression of T1D.

This study is testing a medication, called hydroxychloroquine (HCQ) to assess safety and
effectiveness to prevent individuals at risk of type 1 diabetes (T1D) from progressing to
type 1 diabetes.

HCQ is approved by the U.S. Food and Drug Administration as a treatment for malaria, lupus,
and rheumatoid arthritis. HCQ has been used extensively for treatment of autoimmune disease
in adults, children, and during pregnancy. This medication has not previously been studied as
a treatment to prevent T1D.

The goal of this study is to learn if HCQ can help prevent or delay progression from normal
glucose tolerance (Stage 1) to abnormal glucose tolerance (Stage 2) or type 1 diabetes (Stage
3).

The study involves 5 visits in the first 6 months, then 1 visit every 6 months for the
remainder of the study.

Inclusion Criteria:

1. Participant in TrialNet Pathway to Prevention Study (TN01)

2. Age 3 years or greater at the time of randomization

3. Willing to provide informed consent

4. Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) of baseline

5. Two or more diabetes-related autoantibodies present on two separate samples

6. Weight of 12 kg or greater at screening

7. If a female participant with reproductive potential, willing to avoid pregnancy and
undergo pregnancy testing prior to randomization and at each study visit

8. Anticipated ability to swallow study medication.

Exclusion Criteria:

1. Abnormal Glucose Tolerance or Diabetes

2. History of treatment with insulin or other diabetes therapies

3. Ongoing use of medications known to influence glucose tolerance

4. Ongoing or anticipated future use of medications known to have untoward interactions
with hydroxychloroquine

5. Known hypersensitivity to 4-aminoquinoline compounds

6. G6PD deficiency

7. History of retinopathy

8. Have an active infection at time of randomization

9. Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B
core antibody or surface antigen), or Hepatitis C infection

10. Deemed unlikely or unable to comply with the protocol or have any complicating medical
issues, including prolonged QT interval, a disease previously or likely in the future
to require immunosuppression, or abnormal clinical laboratory results that interfere
with study conduct or cause increased risk.
We found this trial at
27
sites
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Lorraine Levitt Katz, MD
Phone: 267-426-5718
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Louis Philipson, MD
Phone: 773-702-3853
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Desmond Schatz, MD
Phone: 352-294-5759
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Wayne Moore, MD
Phone: 816-960-8943
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Roshanak Monzavi, MD
Phone: 323-361-8641
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: David Baidal, MD
Phone: 305-243-3781
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Toni Moran, MD
Phone: 612-624-5958
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Robin Goland, MD
Phone: 212-851-5465
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Dorothy Becker, MD
Phone: 412-692-7241
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Carol Foster, MD
Phone: 801-585-6227
University of Utah Research is a major component in the life of the U benefiting...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Inas Thomas, MD
Phone: 734-615-4079
University of Michigan Health System The University of Michigan is home to one of the...
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Atlanta, Georgia 30322
Principal Investigator: Andrew Muir, MD
Phone: 404-712-0051
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Aurora, Colorado 80010
Principal Investigator: Andrea Steck, MD
Phone: 303-724-6766
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Buffalo, New York 14203
Principal Investigator: Teresa Quattrin, MD
Phone: 716-323-0075
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Dallas, Texas 75390
Principal Investigator: Philip Raskin, MD
Phone: 241-648-4717
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Greenville, South Carolina 29615
Principal Investigator: Elaine Apperson, MD
Phone: 864-454-5168
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Indianapolis, Indiana 46202
Principal Investigator: Linda DiMeglio, MD
Phone: 317-278-8879
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Indianapolis, IN
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Las Vegas, Nevada 89102
Principal Investigator: Samer Nakhle, MD
Phone: 702-736-5161
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Louisville, Kentucky 40202
Principal Investigator: Kupper Wintergerst, MD
Phone: 502-588-0491
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Nashville, Tennessee 37232
Principal Investigator: William Russell, MD
Phone: 615-337-9597
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Kevan Herold, MD
Phone: 203-737-2760
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: David Sparling, MD
Phone: 405-271-8001
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Oklahoma City, OK
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San Francisco, California 94143
Principal Investigator: Stephen Gitelman, MD
Phone: 415-476-5984
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Seattle, Washington 98101
Principal Investigator: Carla Greenbaum, MD
Phone: 206-342-6945
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Darrell Wilson, MD
Phone: 650-498-4450
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Syracuse, New York 13210
Principal Investigator: Ramachandra Naik, MD
Phone: 315-464-9012
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12901 Bruce B Downs Boulevard
Tampa, Florida 33612
Principal Investigator: Henry Rodriguez, MD
Phone: 813-974-9817
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