LONG-TERM EFFECTS OF NBI 6024 IN TYPE 1 DIABETES SUBJECTS FROM NBI602-0003 TRIAL

NBI602-0003 试验中 NBI 6024 对 1 型糖尿病受试者的长期影响

• 批准号: 7377794
• 负责人: PETER A GOTTLIEB
• 金额: $ 0.03万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7377794
• 关键词: LONG; TERM; EFFECTS; NBI; 6024

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. Type 1 diabetes or insulin-dependent diabetes mellitus (IDDM) affects 19 million people worldwide. Type 1 diabetes appears to be a result of an autoimmune attack in which the body's own immune system destroys the insulin producing cells of the pancreas. One specific type of cell in the immune system, the T cell, appears to be important in the self-destruction that leads to diabetes. Past research has shown that a type of drug called an "altered peptide ligand" (APL) may stop these T cells from harming the pancreas. We are testing the safety and effectiveness of an APL drug, NBI-6024, to stop a newly diagnosed type 1 diabetes patients' T cells from completely destroying the insulin-producing pancreas cells. This study is designed to assess the long-term effect of NBI-6024 in adult and adolescent type 1 diabetes patients. These patients were previously given multiple injections of either the study drug or a "placebo," an injection without a drug (equivalent to a sugar-pill), and then monitored for a year. The patients were given the drug or placebo on a random basis, and the clinical investigators did not know to which group the patients belonged. The year following NBI-6024 dosing, blood tests were done to measure insulin production, T cell activity and general health. A study doctor also did a comprehensive physical exam to further assess general health. This follow-up study will continue these blood tests and physical exams for two more years in order to determine the drug's long-term effects on insulin production, T cell activity and health. This long-term analysis is important because (1) this drug has never been given to new-onset patients, (2) more data will improve the resulting analysis and (3) differences in insulin production between drug treated patients and placebo may be more significant once the "honeymoon" phase is over (honeymoon phase is a time after initial diagnosis, usually less than one year, during which many patients still make some of their own insulin). All patients in this study will have participated in the prior trial (NBI-6024-0003) in which they received the APL drug NBI-6024 or a placebo. Results from this study will help determine the long-term safety of NBI-6024 so that this drug can be further tested as a method to reduce the severity of type 1 diabetes when given to newly diagnosed patients or prevent the disease in high-risk patien

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。1型糖尿病或胰岛素依赖型糖尿病（IDDM）影响着全世界1900万人。1型糖尿病似乎是自身免疫攻击的结果，在这种攻击中，身体自身的免疫系统破坏了胰腺的胰岛素生成细胞。免疫系统中有一种特殊类型的细胞，T细胞，似乎在导致糖尿病的自我毁灭中起着重要作用。过去的研究表明，一种名为“改变肽配体”（APL）的药物可能会阻止这些T细胞损害胰腺。我们正在测试一种APL药物NBI-6024的安全性和有效性，以阻止新诊断的1型糖尿病患者的T细胞完全破坏产生胰岛素的胰腺细胞。本研究旨在评估NBI-6024对成人和青少年1型糖尿病患者的长期疗效。这些患者之前被多次注射研究药物或“安慰剂”，一种不含药物的注射（相当于糖丸），然后被监测一年。患者被随机给予药物或安慰剂，临床研究人员不知道患者属于哪一组。在服用NBI-6024后的一年，进行了血液测试，以测量胰岛素分泌、T细胞活性和总体健康状况。一名研究医生还做了全面的身体检查，以进一步评估总体健康状况。这项后续研究将继续进行两年以上的血液和身体检查，以确定药物对胰岛素产生、T细胞活性和健康的长期影响。这种长期分析很重要，因为(1)这种药物从未给新发患者使用过，(2)更多的数据将改善结果分析，(3)一旦“蜜月”期结束（蜜月期是初步诊断后的一段时间，通常不到一年，在此期间许多患者仍然自己制造一些胰岛素），接受药物治疗的患者和安慰剂之间胰岛素分泌的差异可能会更加显著。本研究的所有患者都参加了先前的试验（NBI-6024-0003），在试验中他们接受了APL药物NBI-6024或安慰剂。本研究的结果将有助于确定NBI-6024的长期安全性，从而进一步测试该药物作为一种降低新诊断患者1型糖尿病严重程度或预防高危患者1型糖尿病的方法