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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 TrialNet联盟的主要目的是开发治疗方法的临床试验，以保护有患1型糖尿病(T1D)风险或新诊断为T1D的个人的胰腺B细胞。人类1型糖尿病是一种慢性、缓慢进展的自身免疫性疾病。这项研究的目的是确定免疫干预策略，以防止从1型糖尿病发病时起β细胞破坏的进展。至少一些β细胞的持续存在应该会改善长期的糖尿病护理，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。其目的是阻止新糖尿病患者的β细胞破坏，因为一旦自身免疫过程进展到完全或接近完全破坏β细胞，免疫调节可能不会很好地发挥作用。这项研究的基本原理是证明在这项研究的4年过程中，在免疫系统副作用最小的情况下，有意义地保存胰岛功能。 这项研究是一项多中心、三臂、随机、双盲、安慰剂对照的临床试验。我们会比较这三个组别，即： 1.霉酚酸酯活性药物与Daclizumab(DZB)安慰剂IV， 2.霉酚酸酯活性药物，Daclizumab活性IV， 3.霉酚酸酯安慰剂和Daclizumab安慰剂IV。 如果结果足够积极，来自这项临床试验的数据可以作为更大规模试验的基础，或者它们可以建议进行其他联合干预试验，这些试验可能取得更好的疗效，或者可能在不需要持续免疫抑制的情况下保留C肽。

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.