NEW ONSET OF TYPE 1 DIABETES MMF/DZB CLINICAL TRIAL

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。子项目及 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。 在过去的10-20年里，大量的证据表明，人类1型糖尿病是一种慢性缓慢进行性自身免疫性疾病。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改善长期糖尿病护理，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。 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很好地起作用。该研究的基本原理是证明在本研究的4年过程中，胰岛功能的有意义的呈现与最小的免疫系统副作用。 本研究是一项多中心、三组、随机、双盲、安慰剂对照的临床试验。将在三组之间进行比较： 1.霉酚酸酯（MMF）活性药物与达克珠单抗（DZB）安慰剂IV 2. MMF活性药物与DZB活性药物IV 3例MMF安慰剂+DZB安慰剂IV 每个参与者的主要结果是他或她在两年访视时进行的4小时混合餐葡萄糖耐量试验的前两个小时内的刺激C肽曲线下面积。次要结局是检查MMF单独使用或与DZB联合使用如何影响以下内容：HbA 1c、低血糖事件总数和低血糖事件重大病例数。 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。

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.