CLINICAL TRIAL: ORAL INSULIN IN RELATIVES AT RISK FOR TYPE I DIABETES MELLITUS

临床试验：有 I 型糖尿病风险的亲属口服胰岛素

• 批准号: 7717928
• 负责人: DARRELL M WILSON
• 金额: $ 0.05万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717928
• 关键词: American; Autoimmunity; Clinical; Clinical Trials; Cohort Analysis; Computer Retrieval of Information on Scientific Projects Database; Development; Diabetes Mellitus; Enrollment; Follow-Up Studies; Funding; Glucose; Grant; Human; Hyperglycemia; Institution; Insulin; Insulin-Dependent Diabetes Mellitus; Intervention; Masks; Metabolic; Oral; Oral Administration; Outcome; Placebos; Prevention; Randomized; Recombinants; Recruitment Activity; Relative (related person); Research; Research Design; Research Personnel; Resources; Risk; Risk Reduction; Sample Size; Side; Source; Specific qualifier value; Subgroup; Symptoms; Testing; Time; United States National Institutes of Health; Upper arm; base; capsule; design; placebo controlled study; prevent

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Study Design: This is an NIH TrialNet study that is a follow up study to our initial oral insulin prevention trial. Subgroup analysis of that study strongly suggests efficiency in the subgroup we are proposing to study here. The study is a 2-arm, multicenter, randomized, double-masked, placebo controlled trial. Subjects: A fixed target sample size has not been specified. Rather, the study is designed as a maximum information trial in which subjects are recruited and followed until the required amount of statistical information is achieved that provides 85% power to detect a 40% risk reduction using a one-sided logrank test at the 0.05 level. Treatment Description: Subjects will receive oral insulin 7.5 mg of recombinant human insulin crystals or placebo in capsules. Objective: The primary objective is to determine whether intervention with repeated oral administration of recombinant human insulin will prevent or delay the development of clinical Type 1 Diabetes Mellitus (T1DM) in subjects at risk for T1DM. Primary Outcome: The primary outcome is the elapsed time from random treatment assignment to the development of diabetes among those enrolled in the primary analysis cohort consisting of subjects with insulin autoimmunity and absence of metabolic abnormalities. Criteria for diabetes onset are as defined by the American Diabetes Association (ADA) based on glucose testing, or the presence of symptoms and unequivocal hyperglycemia.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 研究设计：这是一项NIH TrialNet研究，是我们最初口服胰岛素预防试验的后续研究。 对该研究的亚组分析强烈表明，我们在这里建议研究的亚组的效率。本研究是一项2组、多中心、随机、双盲、安慰剂对照试验。 受试者：未指定固定目标样本量。相反，本研究被设计为最大信息试验，招募受试者并对其进行随访，直至获得所需的统计信息量，使用单侧对数秩检验在0.05水平下提供85%的把握度来检测40%的风险降低。 治疗描述：受试者将接受口服胰岛素7. 5 mg重组人胰岛素晶体或安慰剂胶囊。 目的：主要目的是确定是否进行干预 重复口服施用重组人胰岛素将 预防或延缓临床1型糖尿病的发展 有T1 DM风险的受试者中的T1 DM。 主要结局：主要结局是入组主要分析队列的受试者从随机治疗分配至发生糖尿病的时间，该队列由胰岛素自身免疫和无代谢异常的受试者组成。糖尿病发作的标准由美国糖尿病协会（ADA）根据血糖检测或症状和明确的高血糖症的存在来定义。