Number of Subjects in Study Archive: 201 participants (estimated enrollment)
Study Design: Interventional
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1
Division: DEM
Duration: August 2018 - present
# Recruitment Centers: 51
Treatment: Hydroxychloroquine
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Access to biospecimens for Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus (TN22) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL:
https://clinicaltrials.gov/ct2/show/NCT03428945
This study is testing a medication, 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 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.
The objective of this prevention study is to test if hydroxychloroquine can delay or prevent early stage T1D (Stage 1) from progressing to abnormal glucose tolerance (Stage 2) and ultimately prevent clinical diagnosis (Stage 3).
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.
Inclusion Criteria:
Exclusion Criteria:
This study is ongoing.