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Clinical Trial Details

Trial ID: L7016
Source ID: NCT03428945
Associated Drug: Hydroxychloroquine
Title: Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus
Acronym: TN-22
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03428945/results
Conditions: Type1 Diabetes Mellitus
Interventions: DRUG: Hydroxychloroquine|DRUG: Placebo
Outcome Measures: Primary: Change From Treatment Assignment Glucose Tolerance to Abnormal Glucose Tolerance or Diabetes, The primary outcome is the time in months from random treatment assignment to the development of confirmed abnormal glucose tolerance or clinical diabetes., Glucose tolerance is measured every 6 months for up to 4 years |
Sponsor/Collaborators: Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Collaborators: Juvenile Diabetes Research Foundation
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 273
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2018-08-15
Completion Date: 2022-10-31
Results First Posted: 2024-04-09
Last Update Posted: 2024-04-09
Locations: Children's Hospital Los Angeles, Los Angeles, California, 90027, United States|University of California - San Francisco, San Francisco, California, 94143, United States|Stanford University, Stanford, California, 94305, United States|Barbara Davis Center, Aurora, Colorado, 80045, United States|Yale University School of Medicine, New Haven, Connecticut, 06519, United States|University of Florida, Gainesville, Florida, 32610, United States|University of Miami, Miami, Florida, 33136, United States|USF Diabetes Center, Tampa, Florida, 33612, United States|Emory Children's Center, Atlanta, Georgia, 30322, United States|St. Luke's Humphreys Diabetes Center, Boise, Idaho, 83702, United States|Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States|University of Chicago, Chicago, Illinois, 60637, United States|Indiana University - Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|University of Iowa, Iowa City, Iowa, 52242, United States|University of Kentucky/UK Healthcare, Lexington, Kentucky, 40504, United States|University of Louisville Pediatric Endocrinology, Louisville, Kentucky, 40202, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|University of Michigan Health System, Ann Arbor, Michigan, 48109, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|The Children's Mercy Hospital, Kansas City, Missouri, 64108, United States|Palm Research Center, Inc., Las Vegas, Nevada, 89148, United States|UBMD Pediatrics, Buffalo, New York, 14203, United States|Columbia University, New York, New York, 10032, United States|Joslin Center at SUNY Upstate Medical University, Syracuse, New York, 13210, United States|Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|The University of Oklahoma, Oklahoma City, Oklahoma, 73104, United States|Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104-4399, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States|Endocrinology Specialist / Greenville Health System, Greenville, South Carolina, 29605, United States|GHS - Pediatric Endocrinology, Greenville, South Carolina, 29615, United States|Sanford Children's Specialty Clinic, Sioux Falls, South Dakota, 57105, United States|Vanderbilt Eskind Diabetes Clinic, Nashville, Tennessee, 37232, United States|University of Texas Southwestern, Dallas, Texas, 75390, United States|University of Utah, Salt Lake City, Utah, 84132, United States|University of Virginia Health System, Charlottesville, Virginia, 22908, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States|Royal North Shore Hospital, St. Leonards, New South Wales, 2065, Australia|Women's and Children's Hospital, Adelaide, North Adelaide, South Australia, 5006, Australia|Walter and Eliza Hall Institute of Medical Research, Parkville, Victoria, 3052, Australia|Perth Children's Hospital, Perth, Western Australia, 6840, Australia|Children's Hospital of Eastern Ontario, Ottawa, Ontario, K1H8L1, Canada|The Hospital For Sick Kids, Toronto, Ontario, M5G-1X8, Canada|IWK Health Center, Halifax, NS B3K 6R8, Canada|San Raffaele Hospital, Milan, 20132, Italy|Skane University Hospital, Malmö, 20502, Sweden|Royal Devon and Exeter Hospital, Exeter, Devon, EX2 5DW, United Kingdom|Plymouth Diabetes Clinical Research Unit, Plymouth, Devon, PLG8BX, United Kingdom|Harrogate and District NHS Foundation Trust, Harrogate, North Yorkshire, HG2 7SX, United Kingdom|University of Bristol, Bristol, UK, BS10 5NB, United Kingdom|Nottingham University Hospitals, Nottingham, NG7 2UH, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03428945

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D396 Hydroxychloroquine small molecule DB01611 Details