Hydroxychloroquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At-risk for Type 1 Diabetes Mellitus (T1D)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 273
- 试验地点
- 51
- 主要终点
- Change From Treatment Assignment Glucose Tolerance to Abnormal Glucose Tolerance or Diabetes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Active drug and placebo will be identical in appearance and packaging
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Hydroxychloroquine
Hydroxychloroquine compound for oral use
干预措施: Hydroxychloroquine (Drug)
Placebo
Placebo tablet matching active drug
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Treatment Assignment Glucose Tolerance to Abnormal Glucose Tolerance or Diabetes
时间窗: Glucose tolerance is measured every 6 months for up to 4 years
The primary outcome is the time in months from random treatment assignment to the development of confirmed abnormal glucose tolerance or clinical diabetes.
次要结局
未报告次要终点