Northwest Clinical Center for Type 1 Diabetes - TrialNet

描述（由申请人提供） TrialNet临床中心应用程序分为三个部分。 第一节讨论了我们中心完成DPT-1和完成DPT-1的实力 对1型糖尿病进行更多的研究。NW临床中心 一直是DPT-1的最佳表现场所。从1994年到2000年11月， NW临床中心已经筛选了大约8600名受试者， 受试者/月筛选人数最多的四个州中的三个 都在我们的临床中心的支持下。NW临床 该中心在高风险试验中的入组率排名第二，在总体试验中排名第三。 入组，其次是入组受试者/筛选受试者。此外，本发明还提供了一种方法， 我们的中心一直是DPT-1中心的领导者， 协议。 第二节讨论了目前对第一类危机干预很重要的问题。 糖尿病发病过程。讨论的领域包括DPT-1的未决问题， 以及与人群选择、干预和结果相关的问题 TrialNet协议的措施。 第III节详细描述了拟定的临床试验。我们的假设是 依那西普（Enbrel）单独或与甲氨蝶呤联合使用将改善 新诊断的1型患者中β细胞功能的保留 两年的时间。在本试验中，我们将解决以下三个具体问题 目的：（1）证明依那西普单用或联合 在新诊断患者中与甲氨蝶呤联合使用，（2）选择哪一种 干预更好地保留了新诊断患者的β细胞功能， (3)测试免疫措施是否可以作为影响的替代标志物， 治疗新诊断的患者。 这是一项依那西普的三组、开放标签、II期、随机试验 （Enbrel）或依那西普和甲氨蝶呤（MTX）在新诊断的 1型糖尿病筛选和基线评价后， 患者将入组本研究，并随机分配至三组之一， 治疗组。样本量为162例患者，每例54例 三组主要结果指标是C肽反应峰值， 混合餐刺激。次要结局包括C肽反应， 精氨酸刺激、胰岛素剂量、低血糖事件和血糖 短途旅行此外，我们将使用新技术评估T细胞 活动，以了解自然历史，并确定这些免疫 测量可以作为治疗效果的替代标记。

DESCRIPTION (provided by applicant) This TrialNet clinical center application is divided into three sections. Section I discusses the strength of our center to both complete DPT-1 and to conduct additional studies in Type 1 diabetes. The NW Clinical Center has consistently been a top performing site for DPT-1. From 1994 through Nov. 2000, NW Clinical Center has screened about 8600 subjects, or just over 100 subjects/month. Three of the top four states with the highest number screened per population are under the auspices of our clinical center. The NW Clinical Center is second with enrollment in high-risk trial, third for overall enrollment, and second for enrolled subjects/screened subjects. In addition, our center has been the leader among DPT-1 centers in overall compliance with the protocol. Section II discusses the current issues important to intervention in the Type 1 diabetes disease process. Areas discussed include pending issues for DPT-1, as well as issues related to selection of population, intervention, and outcome measures for TrialNet protocols. Section III details a proposed clinical trial. Our hypothesis is that etanercept (Enbrel) alone or in conjunction with methotrexate will improve preservation of beta cell function in newly diagnosed Type 1 patients over a two year period. In this trial, we will address the following three specific aims: (1) demonstrate the short-term safety of etanercept alone or in conjunction with methotrexate in newly diagnosed patients, (2) select which intervention better preserves beta cell function in newly diagnosed patients, (3) test whether immune measures can serve as surrogate markers for effect of therapy in newly diagnosed patients. This is a three arm, open-label Phase II, randomized trial of etanercept (Enbrel) or etanercept and methotrexate (MTX) in patients with newly diagnosed Type 1 diabetes. Following screening and baseline evaluations, eligible patients will be enrolled in the study and randomly assigned to one of three treatment groups. The sample size is a total of 162 patients with 54 in each of three groups. The primary outcome measure is peak C-peptide response after mixed meal stimulation. Secondary outcomes include C-peptide response to arginine stimulation, insulin dose, hypoglycemic events, and glycemic excursions. In addition, we will use new technologies for assessing T-cell activity to both understand the natural history and determine if these immune measures can serve as surrogate markers for effect of therapy.