PHASE II MULTIPLE-DOSE TREATMENT OF TYPE 1 DIABETES MELLITUS

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他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。 这是一项多中心、2组、随机、开放标签、II期试验，涉及在新发1型糖尿病（T1 DM）患者中使用免疫抑制药物hOKT 3 yl（Ala-Ala）进行0或2个周期的治疗，间隔1年。假设hOKT 3将在诊断后的前2年内阻止胰腺β细胞的胰岛素产生损失并改善血糖控制。更好的血糖控制已被证明可以降低TIDM的长期发病率。受试者将被随机分配至药物治疗组（A组）或对照组（B组）。每个周期内剂量递增，但周期之间无变化。随机化将是2例药物受试者对1例对照受试者，并将按研究中心分层。目前的方案是基于在哥伦比亚大学进行的I/II期和PK/安全性试验，这些试验表明了2002年5月NEJM发表的临床疗效，并证明了药物的安全性。

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. This is a multi-centered, 2 arm, randomized, open label, Phase II trial involving 0 or 2 cycles of treatment one year apart using the immune suppressive drug hOKT3yl (Ala-Ala) in patients with new onset type 1 Diabetes Mellitus (T1DM). It is hypothesized that hOKT3 will arrest the loss of insulin production of the pancreatic beta cells during the first 2 years from diagnosis and improve glycemic control. Greater glycemic control has been shown to result in less long-term TIDM morbidity. Participants will be randomized to drug treatment (Group A) or control (Group B). There is dose escalation within each cycle, but no change between cycles. The randomization will be 2 drug subjects to 1 control subject and will be stratified by study site. The current protocol is based on Phase I/II and PK/Safety trials conducted at Columbia University that suggested clinical efficacy as published in the NEJM in May 2002, and demonstrated safety of the drug.