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Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus (TN-22)

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ClinicalTrials.gov Identifier: NCT03428945
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief 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.

Condition or disease Intervention/treatment Phase
Type1 Diabetes Mellitus Drug: Hydroxychloroquine Drug: Placebo Phase 2

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Treatment assignment (active drug: placebo) will be assigned in a parallel, randomized, 2:1 model. Assignment will be stratified based on prior treatment for T1D prevention and age.
Masking: Double (Participant, Investigator)
Masking Description: Active drug and placebo will be identical in appearance and packaging
Primary Purpose: Prevention
Official Title: Hydroxychloroquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At-risk for Type 1 Diabetes Mellitus (T1D)
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Hydroxychloroquine
Hydroxychloroquine compound for oral use
Drug: Hydroxychloroquine
Hydroxychloroquine for oral administration, dosed by weight
Other Name: Plaquenil

Placebo Comparator: Placebo
Placebo tablet matching active drug
Drug: Placebo
Placebo tablet identical to active drug




Primary Outcome Measures :
  1. Progression to Abnormal Glucose Tolerance or Diabetes [ Time Frame: Study duration is based on events observed; the duration is estimated to be approximately 6 years ]
    The primary outcome is the time from treatment assignment to development of abnormal glucose tolerance or diagnosis of type 1 diabetes



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant in TrialNet Pathway to Prevention Study (TN01)
  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

Exclusion Criteria:

  1. Abnormal Glucose Tolerance or Diabetes
  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 disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428945


Contacts
Contact: Lisa Rafkin 305-243-6146 lrafkin@miami.edu
Contact: Ryan O'Donnell 813-396-9551 Ryan.O'Donnell@epi.usf.edu

Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
Investigators
Study Chair: Carla Greenbaum, MD Type 1 Diabetes TrialNet

Additional Information:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT03428945     History of Changes
Other Study ID Numbers: Hydroxychloroquine
UC4DK117009 ( U.S. NIH Grant/Contract )
UC4DK106993 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
TrialNet

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents