LEVEX STUDY

莱克斯研究

• 批准号: 7952020
• 负责人: Vanita Aroda
• 金额: $ 0.17万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952020
• 关键词: Biometry; Body Composition; Body Weight Changes; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Frequencies; Funding; Galvanic Skin Response; Goals; Grant; Heart Rate; Heating; Hyperglycemia; Hypoglycemia; Inferior; Institution; Lipids; Magnetic Resonance Imaging; Non-Insulin-Dependent Diabetes Mellitus; Oral; Patients; Pharmaceutical Preparations; Phase; Randomized; Research; Research Personnel; Resources; Site; Source; Stratification; United States National Institutes of Health; control trial; exenatide; insulin detemir; open label; primary outcome; prospective; secondary outcome

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 two-site, prospective, randomized, open-label, parallel group, controlled trial of up to 24 weeks in patients with Type 2 Diabetes Mellitus who have poor control as defined by an HgBA1C between 7.5% and 10%. The hypothesis is that insulin detemir will be non-inferior to exenatide. As many as 74 patients (24 at MRI and 50 at WRAMC) will be randomized to either detemir or exenatide with stratification for TZD use. They will continue their oral agent therapy. Phase 1 is 12 weeks and patients not achieving goal A1C will enter a 12 week Phase 2 where they will receive both the initial medication and the alternative agent. Patients who do achieve goal A1C in Phase 1 will be continued on that single agent. The primary outcome is A1C improvement with secondary outcomes including frequency of hypo and hyperglycemia, weight, change in body composition, lipid levels, biometric parameters of activity, heat flux, galvanic skin response, and heart rate.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项两点、前瞻性、随机、开放标签、平行分组对照试验，对HgBA1C在7.5%至10%之间控制不良的2型糖尿病患者进行长达24周的对照试验。假设地特胰岛素的疗效不逊于艾塞那帝。 多达74名患者(24名接受核磁共振检查，50名接受WRAMC治疗)将被随机分为地替米尔组或艾塞那度组，分层使用TZD。他们将继续进行口服药物治疗。第一阶段是12周，没有达到A1C目标的患者将进入12周的第二阶段，在那里他们将接受初始药物和替代药物。在第一阶段达到A1C目标的患者将继续服用该单一药物。主要结果是糖化血红蛋白的改善，次要结果包括低血糖和高血糖的频率、体重、身体成分、血脂水平的变化、活动的生物测定参数、热通量、皮肤电反应和心率。