NCT03428945

Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus

Hydroxychloroquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At-risk for Type 1 Diabetes Mellitus (T1D)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Hydroxychloroquine for oral administration, dosed by weight
DRUG	Placebo	Placebo tablet identical to active drug

Timeline

• Start date: 2018-08-15
• Primary completion: 2022-10-27
• Completion: 2022-10-31
• First posted: 2018-02-12
• Last updated: 2024-04-09
• Results posted: 2024-04-09

Locations

51 sites across 6 countries: United States, Australia, Canada, Italy, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study