Type1 Diabetes MellitusPhase 2TN-22NCT03428945
Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus
A Phase 2 study testing Hydroxychloroquine in people with Type1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 51 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 51 sitesin 6 countries
- Study dates
- 15 Aug 2018to 31 Oct 2022
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
51 sites in 6 countries.
51 sites in 6 countries
United States37 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Emory Children's Center
Atlanta, Georgia, 30322
Barbara Davis Center
Aurora, Colorado, 80045
St. Luke's Humphreys Diabetes Center
Boise, Idaho, 83702
Joslin Diabetes Center
Boston, Massachusetts, 02215
UBMD Pediatrics
Buffalo, New York, 14203
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Texas Southwestern
Dallas, Texas, 75390
University of Florida
Gainesville, Florida, 32610
Endocrinology Specialist / Greenville Health System
Greenville, South Carolina, 29605
GHS - Pediatric Endocrinology
Greenville, South Carolina, 29615
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
Indiana University - Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
The Children's Mercy Hospital
Kansas City, Missouri, 64108
Palm Research Center, Inc.
Las Vegas, Nevada, 89148
University of Kentucky/UK Healthcare
Lexington, Kentucky, 40504
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of Louisville Pediatric Endocrinology
Louisville, Kentucky, 40202
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt Eskind Diabetes Clinic
Nashville, Tennessee, 37232
Yale University School of Medicine
New Haven, Connecticut, 06519
Columbia University
New York, New York, 10032
The University of Oklahoma
Oklahoma City, Oklahoma, 73104
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399
University of Pittsburgh
Pittsburgh, Pennsylvania, 15224
University of Utah
Salt Lake City, Utah, 84132
University of California - San Francisco
San Francisco, California, 94143
Benaroya Research Institute
Seattle, Washington, 98101
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, 57105
Stanford University
Stanford, California, 94305
Joslin Center at SUNY Upstate Medical University
Syracuse, New York, 13210
USF Diabetes Center
Tampa, Florida, 33612
United Kingdom5 sites
University of Bristol
Bristol, UK, BS10 5NB
Royal Devon and Exeter Hospital
Exeter, Devon, EX2 5DW
Harrogate and District NHS Foundation Trust
Harrogate, North Yorkshire, HG2 7SX
Nottingham University Hospitals
Nottingham, NG7 2UH
Plymouth Diabetes Clinical Research Unit
Plymouth, Devon, PLG8BX
Australia4 sites
Women's and Children's Hospital, Adelaide
North Adelaide, South Australia, 5006
Walter and Eliza Hall Institute of Medical Research
Parkville, Victoria, 3052
Perth Children's Hospital
Perth, Western Australia, 6840
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Canada3 sites
IWK Health Center
Halifax, NS B3K 6R8
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H8L1
The Hospital For Sick Kids
Toronto, Ontario, M5G-1X8
About this study
Official title: Hydroxychloroquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At-risk for Type 1 Diabetes Mellitus (T1D)
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.
Read the 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.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- Hydroxychloroquine, Placebo
- Keywords
- TrialNet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
Hydroxychloroquine for oral administration, dosed by weight
PlaceboDrug
Also called Inactive Drug
Placebo tablet identical to active drug
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Hydroxychloroquine compound for oral use Receives: Drug: Hydroxychloroquine |
| Placebo | Placebo comparator | Placebo tablet matching active drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Glucose tolerance is measured every 6 months for up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start15 Aug 2018
- Primary completion27 Oct 2022
- Study completion31 Oct 2022
Why it stopped: This trial has undergone a prespecified interim analysis which determined that this treatment provides no statistically significant delay in the onset of abnormal glucose tolerance or Type 1 Diabetes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Carla Greenbaum, MD, Study chair, Type 1 Diabetes TrialNet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428945
- Sponsor's protocol ID
- Hydroxychloroquine
- Other IDs
- UC4DK117009, UC4DK106993
- Acronym
- TN-22
- Status last verified
- Jul 2023
- First submitted
- 24 Jan 2018
- Last updated
- 9 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No