STUDY OF LONG-TERM ADMINISTRATION OF NATEGLINIDE AND VALSARTAN

那格列奈和缬沙坦长期服用的研究

• 批准号: 7376254
• 负责人: VIVIAN A FONSECA
• 金额: $ 0.02万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376254
• 关键词: STUDY; LONG; TERM; ADMINISTRATION; NATEGLINIDE

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 study is a multinational, randomized, double-blind, placebo-controlled, forced-titration 2 x 2 factorial design study of the efficacy and safety of long term administration of nateglinide and valsartan in the prevention of diabetws and cardiovascular outcomes in subjects with impared glucose tolerance (IGT). In addition, we will conduct a substudy to determine whether endothelial function and body composition predict the development of diabetes and cv events in patients with IGT. Patients from all 6 New Orleans Navigator study sites will be invited to participate in this sub study (which may also be incorporated as a substudy at other sites willing/able to carry out these procedures). Male and female subjects with impaired glucose tolerance on OGTT screening and greater than or equal to 1 cardiovascular risk factors (s) (RF) or greater than or equal to 1 cardiovascular disease (CVD) are eligible to participate. Approximately 1875 subjects will be randomized per treatment group. At the end of the core phase, the data will be analyzed for the time to progression to diabetes endpoint while the trial will continue in a blinded fashion. In case of a statistically significant effect of one or both drugs, submission of a registration dossier will be considered. If no statistical significance is reached by any of the drugs the trial will continue and the analysis of the cardiovascular morbidity/mortality endpoint will be exploratory. Approximately 7500 subjects from 600-800 centers in approximately 40 countries are to be randomized. Screening for eligibility will take place 1 month prior to treatment start and requires an oral glucose tolerance test (OGTT) to confirm eligibility. After receipt of the appropriate baseline data and cardiovascular disease status, eligible subjects will be randomly assigned to one of the four treatment groups (ratio 1:1:1:1), i.e. nateglinide 60 mg ac, valsartan 160 mg od, the combination of nateglinide 60 mg ac and valsartan 160 mg od, the combination of nateglinide 60 mg ac and valsartan l60 mg od, or placebo, using a computerized interactive voice response system (IVRS). Study accrual is expected to require approximately 18 months. The duration of study follow-up is fixed for the progression to diabetes endpoint at a minimum of 3 years from last-patient first-visit (LPFV). This duration also defines the duration of the core phase. For the cardiovascular endpoint, 1000 patients with an event are required. A total duration of follow-up of 5 years and 9 months after FPFV is anticipated.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究是一项多国、随机、双盲、安慰剂对照、强制滴定2×2析因设计，研究长期服用那格列奈和valsartan预防糖耐量受损(IGT)受试者糖尿病和心血管结局的有效性和安全性。此外，我们还将进行一项子研究，以确定内皮功能和身体成分是否能预测IGT患者的糖尿病和心血管事件的发展。来自新奥尔良导航仪所有6个研究站点的患者将被邀请参加这项子研究(该研究也可能被纳入愿意/能够执行这些程序的其他站点的子研究)。糖耐量低减且心血管危险因素(S)(RF)或心血管疾病(CVD)大于或等于1的男女受试者均有资格参加。大约1875名受试者将被随机分配到每个治疗组。在核心阶段结束时，数据将被分析为进展到糖尿病终点的时间，而试验将以盲法继续进行。如果一种或两种药物在统计学上有显著效果，将考虑提交注册档案。如果任何一种药物没有达到统计学意义，试验将继续进行，心血管发病率/死亡率终点的分析将是探索性的。来自大约40个国家的600-800个中心的大约7500名受试者将被随机分组。合格筛查将在治疗开始前1个月进行，并需要进行口服葡萄糖耐量试验(OGTT)以确认合格。在收到适当的基线数据和心血管疾病状况后，符合条件的受试者将被随机分配到四个治疗组(比例为1：1：1：1)，即那格列奈60 mg ac，valsartan 160 mg od，那格列奈60 mg ac和valsartan 160 mg od的组合，那格列奈60 mg ac和valsartan L60 mg od的组合，或使用计算机交互语音应答系统(IVRS)的安慰剂。学习应计费用预计需要大约18个月。对于进展为糖尿病终点的研究，随访的持续时间固定为从最后一位患者首次就诊(LPFV)起至少3年。该持续时间还定义了核心阶段的持续时间。对于心血管终点，需要1000名有事件的患者。预计总的随访期为5年零9个月。