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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。TrialNet联盟的主要目的是开展临床试验，以保护患有1型糖尿病（T1D）或新诊断为T1D的个体的胰腺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。本研究的目的是确定免疫干预策略，以防止1型糖尿病发病时β细胞破坏的进展。至少一些β细胞的持续存在将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，这是糖尿病治疗的结果。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，免疫调节可能无法单独发挥作用。该研究的基本原理是证明在4年的研究过程中，胰岛功能有意义的保存，免疫系统副作用最小。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。将对三组进行比较，这三组是：1。霉酚酸酯活性药物与Daclizumab （DZB）安慰剂IV， 2。霉酚酸酯活性药物与Daclizumab活性IV， 3。霉酚酸酯mofetil安慰剂与Daclizumab安慰剂IV。如果结果足够积极，该临床试验的数据可以作为更大规模试验的基础，或者他们可以建议其他联合干预试验，可能达到更好的疗效或可能保留c肽，而不需要持续的免疫抑制。

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 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.