HOE 901 INSULIN COMPARE WITH NPH HU INSULIN IN TYPE I DIABETES MELLITUS

HOE 901 胰岛素与 NPH HU 胰岛素在 I 型糖尿病中的比较

• 批准号: 6291142
• 负责人: CHARLES J CLARK
• 金额: $ 0.04万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 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/6291142
• 关键词: analog; blood glucose; clinical research; diabetes mellitus therapy; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; insulin; insulin dependent diabetes mellitus; quality of life

The human insulin analogue HOE 901 was developed to meet the medical need for a long- acting insulin that can be administered as a single daily injection to yield normal or near- normal blood glucose control with a basal insulin profile that is as smooth as possible over a 24-hour period. Such a preparation should provide better control of nocturnal glycemia and fasting blood glucose levels, and a more stable daytime blood glucose profile. The purpose of this study is to compare the efficacy and safety of HOE 901 with those of NPH human insulin. The study will be performed in subjects with type 1 diabetes who are receiving multi-dose insulin therapy with NPH and regular human insulin. The comparison of HOE 901 and NPH human insulin in terms of efficacy will be based on levels of glycohemoglobin (GHb). In addition to this primary objective, blood glucose variability, other indicators of metabolic control, and quality of life will be compared between the two treatment groups. Safety will be assessed by laboratory findings and the analysis of clinical events.

开发人胰岛素类似物HOE 901是为了满足对长效胰岛素的医疗需求，长效胰岛素可每日单次注射给药，以产生正常或接近正常的血糖控制，基础胰岛素曲线在24小时内尽可能平稳。这样的制剂应该提供更好的夜间血糖和空腹血糖水平的控制，以及更稳定的日间血糖曲线。本研究旨在比较HOE 901与NPH人胰岛素的疗效和安全性。本研究将在接受NPH和常规人胰岛素多次给药胰岛素治疗的1型糖尿病受试者中进行。HOE 901和NPH人胰岛素在疗效方面的比较将基于糖化血红蛋白（GHb）水平。 除此主要目的外，还将比较两个治疗组之间的血糖变异性、代谢控制的其他指标和生活质量。 将通过实验室检查结果和临床事件分析评估安全性。