Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus
NCT ID: NCT03428945
Last Updated: 2024-04-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
273 participants
INTERVENTIONAL
2018-08-15
2022-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Hydroxychloroquine
Hydroxychloroquine compound for oral use
Hydroxychloroquine
Hydroxychloroquine for oral administration, dosed by weight
Placebo
Placebo tablet matching active drug
Placebo
Placebo tablet identical to active drug
Interventions
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Hydroxychloroquine
Hydroxychloroquine for oral administration, dosed by weight
Placebo
Placebo tablet identical to active drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
11. 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.
12. Be pregnant or breastfeeding.
3 Years
ALL
No
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Carla Greenbaum, MD
Role: STUDY_CHAIR
Type 1 Diabetes TrialNet
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
University of California - San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Barbara Davis Center
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
USF Diabetes Center
Tampa, Florida, United States
Emory Children's Center
Atlanta, Georgia, United States
St. Luke's Humphreys Diabetes Center
Boise, Idaho, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
University of Chicago
Chicago, Illinois, United States
Indiana University - Riley Hospital for Children
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kentucky/UK Healthcare
Lexington, Kentucky, United States
University of Louisville Pediatric Endocrinology
Louisville, Kentucky, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
The Children's Mercy Hospital
Kansas City, Missouri, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
UBMD Pediatrics
Buffalo, New York, United States
Columbia University
New York, New York, United States
Joslin Center at SUNY Upstate Medical University
Syracuse, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The University of Oklahoma
Oklahoma City, Oklahoma, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Endocrinology Specialist / Greenville Health System
Greenville, South Carolina, United States
GHS - Pediatric Endocrinology
Greenville, South Carolina, United States
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, United States
Vanderbilt Eskind Diabetes Clinic
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Benaroya Research Institute
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Women's and Children's Hospital, Adelaide
North Adelaide, South Australia, Australia
Walter and Eliza Hall Institute of Medical Research
Parkville, Victoria, Australia
Perth Children's Hospital
Perth, Western Australia, Australia
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital For Sick Kids
Toronto, Ontario, Canada
IWK Health Center
Halifax, , Canada
San Raffaele Hospital
Milan, , Italy
Skane University Hospital
Malmo, , Sweden
Royal Devon and Exeter Hospital
Exeter, Devon, United Kingdom
Plymouth Diabetes Clinical Research Unit
Plymouth, Devon, United Kingdom
Harrogate and District NHS Foundation Trust
Harrogate, North Yorkshire, United Kingdom
University of Bristol
Bristol, UK, United Kingdom
Nottingham University Hospitals
Nottingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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TrialNet Public Website
Other Identifiers
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