Hydroxychloroquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At-risk for Type 1 Diabetes Mellitus (T1D)
Who is this study for? Children, adolescent, and adults at risk for developing type 1 diabetes
What treatments are being studied? Hydroxychloroquine
Status: Terminated
Location: See all (51) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Healthy Volunteers: f
View:
• Participant in TrialNet Pathway to Prevention Study (TN01)
• Age 3 years or greater at the time of randomization
• Willing to provide informed consent
• Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) of baseline
• Two or more diabetes-related autoantibodies present on two separate samples
• Weight of 12 kg or greater at screening
• If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and at each study visit
• Anticipated ability to swallow study medication.
Locations
United States
California
Children's Hospital Los Angeles
Los Angeles
University of California - San Francisco
San Francisco
Stanford University
Stanford
Colorado
Barbara Davis Center
Aurora
Connecticut
Yale University School of Medicine
New Haven
Florida
University of Florida
Gainesville
University of Miami
Miami
USF Diabetes Center
Tampa
Georgia
Emory Children's Center
Atlanta
Iowa
University of Iowa
Iowa City
Idaho
St. Luke's Humphreys Diabetes Center
Boise
Rocky Mountain Clinical Research
Idaho Falls
Illinois
University of Chicago
Chicago
Indiana
Indiana University - Riley Hospital for Children
Indianapolis
Kentucky
University of Kentucky/UK Healthcare
Lexington
University of Louisville Pediatric Endocrinology
Louisville
Massachusetts
Joslin Diabetes Center
Boston
Michigan
University of Michigan Health System
Ann Arbor
Minnesota
University of Minnesota
Minneapolis
Missouri
The Children's Mercy Hospital
Kansas City
Nevada
Palm Research Center, Inc.
Las Vegas
New York
UBMD Pediatrics
Buffalo
Columbia University
New York
Joslin Center at SUNY Upstate Medical University
Syracuse
Ohio
Cleveland Clinic Foundation
Cleveland
Oklahoma
The University of Oklahoma
Oklahoma City
Pennsylvania
Childrens Hospital of Philadelphia
Philadelphia
University of Pittsburgh
Pittsburgh
South Carolina
Endocrinology Specialist / Greenville Health System
Greenville
GHS - Pediatric Endocrinology
Greenville
South Dakota
Sanford Children's Specialty Clinic
Sioux Falls
Tennessee
Vanderbilt Eskind Diabetes Clinic
Nashville
Texas
University of Texas Southwestern
Dallas
Utah
University of Utah
Salt Lake City
Virginia
University of Virginia Health System
Charlottesville
Washington
Benaroya Research Institute
Seattle
Wisconsin
Medical College of Wisconsin
Milwaukee
Other Locations
Australia
Women's and Children's Hospital, Adelaide
North Adelaide
Walter and Eliza Hall Institute of Medical Research
Parkville
Perth Children's Hospital
Perth
Royal North Shore Hospital
St. Leonards
Canada
IWK Health Center
Halifax
Children's Hospital of Eastern Ontario
Ottawa
The Hospital For Sick Kids
Toronto
Italy
San Raffaele Hospital
Milan
Sweden
Skane University Hospital
Malmö
United Kingdom
University of Bristol
Bristol
Royal Devon and Exeter Hospital
Exeter
Harrogate and District NHS Foundation Trust
Harrogate
Nottingham University Hospitals
Nottingham
Plymouth Diabetes Clinical Research Unit
Plymouth
Time Frame
Start Date: 2018-08-15
Completion Date: 2022-10-31
Participants
Target number of participants: 273
Treatments
Experimental: Hydroxychloroquine
Hydroxychloroquine compound for oral use
Placebo_comparator: Placebo
Placebo tablet matching active drug
Authors
Michael Tansey, Kurt Griffin, Daniel Flynn, Roshanak Monzavi, David Liljenquist, Rosanna Fiallo-Scharer, Dorothy Becker, Susanne Cabrera, Teresa Quattrin, Andrew Muir, David Baidal, Robin Goland, David Sparling, Desmond Schatz, Elizabeth Davis, Lorraine Levitt Katz, Andrea Steck, Kupper Wintergerst, Darrell Wilson, Ramachandra Naik, Samer Nakhle, Sandra Weber, Jason Gaglia, Kathryn Thrailkill, Sumana Narasimhan, Kevan Herold, Stephen Gitelman, Wayne Moore, Elaine Apperson, Inas Thomas, Carla Greenbaum, Christopher Moudiotis, Peter Hammond, Philip Raskin, Arati Mokashi, Polly Bingley, Elizabeth Cummings, Louise Denvir, Margaret Lawson, Henrik Borg, Peter Colman, Emanuele Bosi, Diane Wherrett, Jennifer Couper, John Wentworth
Related Therapeutic Areas
Sponsors
Collaborators: Juvenile Diabetes Research Foundation
Leads: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)