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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03428945
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : August 28, 2018
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)
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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
  8. Anticipated ability to swallow study medication.

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 identifier (NCT number): NCT03428945

Contact: Lisa Rafkin 305-243-6146
Contact: Ryan O'Donnell 813-396-9551 Ryan.O'

United States, Colorado
Barbara Davis Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Betsy Burke    303-724-6766   
Principal Investigator: Andrea Steck, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Jennifer Hosford    352-294-5759   
Contact: Paula Towe    352-294-5761   
Principal Investigator: Desmond Schatz, MD         
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Della Matheson    305-243-3781   
Contact: Natalia Sanders-Branca    305-243-6616   
Principal Investigator: David Baidal, MD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: David Groscost    412-692-7241   
Contact: Kelli Delallo    412-692-5210   
Principal Investigator: Dorothy Becker, MD         
United States, Tennessee
Vanderbilt Eskind Diabetes Clinic Recruiting
Nashville, Tennessee, United States, 37232
Contact: Brenna Dixon    615-337-9597   
Contact: Faith Brendle    615-936-8638   
Principal Investigator: William Russell, MD         
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Lauren Boyles    241-648-4717   
Principal Investigator: Philip Raskin, MD         
United States, Washington
Benaroya Research Institute Recruiting
Seattle, Washington, United States, 98101
Contact: Mary Ramey    206-342-6945   
Contact: Marli McCulloch-Olson    206-515-5239   
Principal Investigator: Carla Greenbaum, MD         
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
Study Chair: Carla Greenbaum, MD Type 1 Diabetes TrialNet

Additional Information:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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: August 28, 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):

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