NEW ONSET OF TYPE 1 DIABETES MYCOPHENOLATE MOFETIL - DACLIZUMAB CLINICAL TRIAL

1 型糖尿病新发霉酚酸酯 - 达利珠单抗临床试验

• 批准号: 7717510
• 负责人: HENRY RODRIGUEZ
• 金额: $ 0.16万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 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/7717510
• 关键词: Adverse effects; Autoimmune Diseases; Autoimmune Process; B-Lymphocytes; Beta Cell; Biological Preservation; C-Peptide; Caring; Chronic; Clinical Treatment; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Controlled Clinical Trials; Daclizumab; Data; Diabetes Mellitus; Disease; Funding; Grant; Human; Hypoglycemia; Immune; Immune system; Immunosuppression; Individual; Institution; Insulin-Dependent Diabetes Mellitus; Intervention; Intervention Trial; Masks; Newly Diagnosed; Pancreas; Pharmaceutical Preparations; Placebo Control; Placebos; Purpose; Randomized; Research; Research Personnel; Resources; Risk; Source; Therapeutic immunosuppression; Time; United States National Institutes of Health; Upper arm; Work; base; diabetic; immunoregulation; improved; islet; mycophenolate mofetil; 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. The major purpose of the TrialNet consortium is to develop clinical trials of treatments that protect pancreatic B-cells in individuals who are at risk for developing type 1 diabetes (T1D) or who have newly diagnosed T1D. Type 1 diabetes in humans is a chronic, slowly progressive autoimmune disease. The objective of this study is to identify immune intervention strategies that will prevent the progression of beta cell destruction from the time of onset of type 1 diabetes. The persistence of at least some beta cells should improve long-term diabetes care and prevent not only complications of the disease itself but also hypoglycemia, which is a consequence of its management. The aim is to arrest beta cell destruction in newly diabetic subjects because immune modulation may not work well alone once the autoimmune process has progressed to complete or near complete destruction of beta cells. The study's rationale is to demonstrate a meaningful preservation of islet function with minimal immune system side effects over the 4-year course of this study. The study is a multi center, three arm, randomized, double masked, placebo controlled clinical trial. Comparisons will be made among the three groups which are: 1. Mycophenolate mofetil active drug with Daclizumab (DZB) placebo IV, 2. Mycophenolate mofetil active drug with Daclizumab active IV, 3. Mycophenolate mofetil placebo with Daclizumab placebo IV. The data from this clinical trial could serve as the basis for a larger trial if the results are sufficiently positive, or they could suggest other combined intervention trials that might achieve either better efficacy or potentially preserve C-peptide without the need for continued immunosuppression.

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。 TrialNet联盟的主要目的是开发保护1型糖尿病（T1 D）风险或新诊断为T1 D的个体的胰腺B细胞的治疗的临床试验。 人类1型糖尿病是一种慢性、缓慢进展的自身免疫性疾病。 本研究的目的是确定免疫干预策略，以防止从1型糖尿病发作时β细胞破坏的进展。 至少一些β细胞的持续存在应该可以改善糖尿病的长期护理，不仅可以预防疾病本身的并发症，还可以预防低血糖，这是其管理的结果。 目的是阻止新糖尿病受试者中的β细胞破坏，因为一旦自身免疫过程已经进展到β细胞的完全或接近完全破坏，免疫调节可能无法单独良好地起作用。 该研究的基本原理是证明在本研究的4年过程中可以有效地保留胰岛功能，同时将免疫系统副作用降至最低。 本研究是一项多中心、三组、随机、双盲、安慰剂对照临床试验。 将对以下三组进行比较： 1.霉酚酸酯活性药物与达克珠单抗（DZB）安慰剂IV， 2.霉酚酸酯活性药物与达克珠单抗活性IV， 3.吗替麦考酚酯安慰剂与达克珠单抗安慰剂IV。 如果结果足够积极，这项临床试验的数据可以作为更大规模试验的基础，或者它们可以建议其他联合干预试验，这些试验可能会获得更好的疗效或可能保留C肽，而不需要继续进行免疫抑制。