Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Type1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03428945

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

273

Starts

2018-08-15

Expected to finish

2022-10-31

Last updated by the study team

2024-04-09

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Abnormal Glucose Tolerance or Diabetes
• History of treatment with insulin or other diabetes therapies
• Ongoing use of medications known to influence glucose tolerance
• Ongoing or anticipated future use of medications known to have untoward interactions with hydroxychloroquine
• Known hypersensitivity to 4-aminoquinoline compounds
• G6PD deficiency
• History of retinopathy
• Have an active infection at time of randomization
• Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection
• 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.
• 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.
• Be pregnant or breastfeeding.

Where it is running

• 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
• Children's Hospital Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.