HUMAN INSULIN ANALOGUE X14 & REGULAR HUMAN INSULIN AS MEAL RELATED INSULIN

人胰岛素类似物 X14

• 批准号: 6113013
• 负责人: JANET MCGILL
• 金额: $ 2.44万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6113013
• 关键词: clinical research; clinical trials; diabetes mellitus therapy; eating; human subject; human therapy evaluation; injection /infusion; insulin; insulin dependent diabetes mellitus; peptide hormone analog

Multicenter open-label asymmetrically randomized (1:1 X14 to Regular Human Insulin) trial with two parallel active treatment groups. An open-label trial has been chosen because Regular, Human Insulin is recommended to be injected 30 minutes before meals while X14 is to be injected immedialy before meals. Blinding the study (double dummy) would mean an unacceptable number of injections per subject per day. a fixed four week run-in period will ensure that all subjects are on a multiple injection treatment regimen with Regular, Human Insulin as meal related insulin and NPH, Human Insulin as basal insulin and trained in trial related procedures prior to randomization.

一项包含两个平行活性治疗组的多中心、开放标签、非对称随机（1：1 X14至常规人胰岛素）试验。 选择了一项开放标签试验，因为常规人胰岛素建议在饭前30分钟注射，而X14建议在饭前立即注射。 研究设盲（双模拟）意味着每例受试者每天的注射次数不可接受。 固定的四周导入期将确保所有受试者接受多次注射治疗方案，其中常规人胰岛素作为膳食相关胰岛素，NPH人胰岛素作为基础胰岛素，并在随机化之前接受试验相关程序的培训。