Northwest Clinical Center for Type 1 Diabetes - TrialNet

描述(由申请人提供) 本TrialNet临床中心申请分为三个部分。 第一节讨论了我们中心在完成DPT-1和 对1型糖尿病进行额外的研究。西北临床中心有 一直是DPT-1表现最好的网站。从1994年到2000年11月， 西北临床中心已经对大约8600名受试者进行了筛查，即刚刚超过100人 科目/月。人数最多的四个州中有三个被筛查 由我们的临床中心赞助。NW临床医院 中心在高风险试验中排名第二，总体排名第三 第二个是注册科目/筛选科目。此外, 我们的中心在总体上符合DPT-1中心的要求方面处于领先地位 协议。 第二节讨论了当前对第一类干预很重要的问题 糖尿病的病程。讨论的领域包括DPT-1的未决问题，如 以及与人口选择、干预和结果相关的问题 TrialNet协议的措施。 第三节详细介绍了一项拟议的临床试验。我们的假设是 依那西普(Enbrel)单独或与甲氨蝶呤联合使用会有改善 新诊断的1型患者超过一年的β细胞功能的保存 为期两年。在本试验中，我们将解决以下三个具体问题 目的：(1)证明依那西普单独或联合应用的短期安全性。 在新诊断的患者中联合甲氨蝶呤，(2)选择哪一种 干预措施更好地保护了新诊断患者的β细胞功能， (3)检测免疫措施是否可作为检测疫苗效果的替代指标 对新诊断的患者进行治疗。 这是一项三臂开放标签第二阶段依那西普的随机试验 (Enbrel)或依那西普加甲氨蝶呤(MTX)治疗新诊断的甲氨蝶呤 1型糖尿病。经过筛选和基线评估后，符合条件 患者将被纳入研究，并随机分配到三组中的一组 治疗组。样本大小为162名患者，每名患者54名 三组。主要结果衡量标准是术后C肽峰值反应。 混合餐刺激。次要结果包括C-肽对 精氨酸刺激、胰岛素剂量、低血糖事件和血糖 短途旅行。此外，我们将使用新技术来评估T细胞 既要了解自然历史，又要确定这些免疫 治疗措施可作为判断治疗效果的替代指标。

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.