28 WEEK MULTI CENTER CONTROLLED RANDOMIZED OPEN CLINICAL TRIAL COMPARING HOE

28 周多中心对照随机开放临床试验比较 HOE

• 批准号: 6117876
• 负责人: CHARLES J CLARK
• 金额: $ 1.7万
• 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/6117876
• 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.

人胰岛素类似物HOE 901是为满足医疗需求而开发的 长效胰岛素可每日服用一次 注射以达到正常或接近正常的血糖控制 24 小时内尽可能平稳的基础胰岛素曲线。 这种制剂应该可以更好地控制夜间血糖，并且 空腹血糖水平和更稳定的日间血糖 轮廓。 本研究的目的是比较 HOE 901 的功效和安全性 与 NPH 人胰岛素。 该研究将在患有 1 型糖尿病的受试者中进行，这些受试者是 接受 NPH 和常规人胰岛素的多剂量胰岛素治疗。 HOE 901与NPH人胰岛素的功效比较 基于糖化血红蛋白 (GHb) 的水平。 除了这个初级 客观、血糖变异性、其他代谢指标 将比较两种治疗之间的控制和生活质量 组。 安全性将通过实验室结果和分析进行评估 的临床事件。