Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus (TN-22)
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|ClinicalTrials.gov Identifier: NCT03428945|
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : January 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Type1 Diabetes Mellitus||Drug: Hydroxychloroquine Drug: Placebo||Phase 2|
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|
|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|
|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|
Hydroxychloroquine compound for oral use
Hydroxychloroquine for oral administration, dosed by weight
Other Name: Plaquenil
Placebo Comparator: Placebo
Placebo tablet matching active drug
Placebo tablet identical to active drug
- Change from Treatment Assignment Glucose Tolerance to Abnormal Glucose Tolerance or Diabetes [ Time Frame: Glucose tolerance is measured every 6 months for approximately 6 years ]The primary outcome is the time from treatment assignment to changes in glucose tolerance. The time to development of abnormal glucose tolerance or the diagnosis of type 1 diabetes will be measured to identify these changes.
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
|Contact: Lisa Rafkinfirstname.lastname@example.org|
|Contact: Ryan O'Donnell||813-396-9551||Ryan.O'Donnell@epi.usf.edu|
|Study Chair:||Carla Greenbaum, MD||Type 1 Diabetes TrialNet|