EUCTR2006-006550-96-IT进行中（未招募）1 期
Oral insulin for prevention of diabetes in relatives at risk for type 1 diabetes mellitus - ND
IDDK TYPE 1 DIABETES TRIALNET0 个研究点目标入组 300 人开始时间: 2008年4月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. have a proband with T1Dm 2. if the proband is a first degree relative the partecipant must be 3-45 years of age. If the proband is a second or third degree relative the partecipant must be 3-20 years of age. 3. OGTT performed within 7 weeks prior to randomization with: fasting plasma glucose <110 mg/dl 2 hour plasma glucose <140 mg/dl 4. mIAA confirmed positive within the previous six months. 5. two samples with at least one autoantibody other than mIAA positive within the previous six months. 6. willing to sign Informed Consent Form.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. does not satisfy the above inclusion criteria. 2. has severe active disease. 3. prior partecipation in a trial for prevention of T1DM. 4. ongoing use of medications known to influence glucose. 5. Pregnant women or lactating. 6. OGTT that reveals diabetes, Impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) 7. sunject has HLADQA1*0102,HLADQB1*0602.
研究者
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