Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus

  • STATUS
    Recruiting
  • End date
    Aug 6, 2024
  • participants needed
    201
  • sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Updated on 6 August 2021

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.

Description

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.

Details
Condition Type1 Diabetes Mellitus
Treatment Placebo, hydroxychloroquine
Clinical Study IdentifierNCT03428945
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last Modified on6 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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How to participate?

Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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