NCT00198146已完成2 期
PD Initiated/Prevention of Diabetes Progression Trial (PDPT) ZEN119
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Area under the curve, Glucagon Stimulation Testing for c-peptide measurements at 0, +6min and +10min intervals over 2 years
研究概览
简要总结
The primary purpose of this study is to determine the efficacy and safety of daclizumab in preventing the progression of diabetes in children who have just been diagnosed with type I diabetes. Additional purposes of the study are to investigate the amount of drug in the children, how quickly it is eliminated from the blood, and analyze the effect of the drug on the immune reaction to diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed type 1 diabetes without previous insulin or oral hypoglycemic therapy.
- •ages 2 to 40 years at diagnosis
- •enroll within 3 months of diagnosis
- •test positive for at least one of the biochemical autoantibodies (ICA-512, GAD 65 or IAA) prior to enrolling
排除标准
- •Previous treatment with an anti-IL-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety and efficacy of daclizumab.
- •Other immunosuppressive drugs including, but not limited to, corticosteroids, cyclosporine, tacrolimus, rapamycin, mycophenolate mofetil, or azathioprine.
- •Active significant infection
- •Limited life expectancy because of disease other than diabetes
- •Pregnancy
结局指标
主要结局
Area under the curve, Glucagon Stimulation Testing for c-peptide measurements at 0, +6min and +10min intervals over 2 years
次要结局
- Insulin requirements (units/kg/day)
- HbA1c
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Power-Up: An Effectiveness Trial of the Diabetes Prevention ProgramPre-DiabetesType 2 DiabetesNCT04104243Albert Einstein College of Medicine301
已完成
4 期
A Clinical Trial to Prevent New Onset Diabetes After TransplantationPrevention of New Onset Diabetes Among Kidney Transplant PatientsNCT01683331University of Michigan251
已完成
不适用
Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal FormulationDiabetes MellitusPre DiabetesNCT03884920Islamia University of Bahawalpur57
终止
4 期
Diabetes Prevention With Lifestyle Intervention and Metformin EscalationDiabetesNCT03258723Yale University114
终止
4 期
Influence of Diabetes Control on Treatment of Diabetic Macular Edema With RanibizumabVisual Acuity Reduced TransientlyMacular Edema, CystoidNCT02665689Prof. Dr. Antonia M. Joussen4