NEW ONSET OF TYPE 1 DIABETES MMF/DZB 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。 过去10-20年发展起来的大量证据表明，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在这项研究的4年过程中，以最小的免疫系统副作用展示胰岛功能的有意义的呈现。 这项研究是一项多中心、三臂、随机、双掩蔽、安慰剂对照的临床试验。将在三个组之间进行比较： 1.霉酚酸酯(MMF)活性药物与Daclizumab(DZB)安慰剂IV 2.MMF活性药物与DZB活性药物IV 3 MMF安慰剂和DZB安慰剂IV 每个参与者的主要结果是在为期两年的访问中进行的4小时混合餐糖耐量测试的前两个小时内，他或她的刺激C肽曲线下的面积。次要结果是检查MMF单独或与DZB联合使用如何影响以下指标：糖化血红蛋白、低血糖事件的总数以及低血糖事件的主要病例数。 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 great body of evidence developed over the last 10-20 years suggests that 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 complication 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 the beta cells. The study's rationale is to demonstrate a meaningful presentation of islet function with minimal immune system side effects over the 4-year course of this study. This study is a multi-center, three-arm, randomized, double masked, placebo-controlled clinical trial. Comparisons will be made among three groups: 1. Mycophenolate Mofetil (MMF) active drug with Daclizumab (DZB) placebo IV 2. MMF active drug with DZB active drug IV 3 MMF placebo with DZB placebo IV The primary outcome of each participant is his or her area under the stimulated C-peptide curve over the first two hours of a 4-hour mixed meal glucose tolerance test conducted at the two-year visit. Secondary outcomes are to examine how MMF alone or in conjunction with DZB affects the following: HbA1c, total number of hypoglycemia events, and number of major cases of hypoglycemic events. 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.