16 WEEK MULTICENTER CLINICAL TRIAL COMPARING H0E901 W/ NPH HUMAN INSULIN

比较 H0E901 与 NPH 人胰岛素的 16 周多中心临床试验

• 批准号: 6113033
• 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/6113033
• 关键词: Escherichia coli; antibacterial antibody; blood glucose; clinical chemistry; clinical research; diabetes mellitus therapy; drug screening /evaluation; glycation; hematology; hemoglobin As; human subject; human therapy evaluation; hypoglycemia; insulin; insulin dependent diabetes mellitus; recombinant proteins

The purpose of this study is to compare the efficacy and safety of HOE901 with that of NPH human insulin when used with insulin lispro in subjects with type I diabetes over a period of 16 weeks. This study will be performed in subjects with type I diabetes, treated with insulin, with s screening GHb of <12.0%. The comparison of HOE901 and NPH human insulin interms of efficacy will be based on levels of GHb. Measurement of GHb is a clinically useful means of assesing glycemic control in diabetes. GHb values reflect blood glucose levels over theprevious 2-3 months. For the secondary objectives, fasting glucose, variability of fasting glucose, hypoglycemia and pharmacoeconomics will be compared between the two treatment groups. Safety will be assessed on the bases of an analysis of clinical events, standard clinical events, standard clinical chemistry and hematology findings and determination of E. coli antibodies and insulin antibodies.

本研究的目的是比较 HOE901 与 NPH 人胰岛素与赖脯胰岛素在 I 型糖尿病受试者中使用 16 周的疗效和安全性。 这项研究将在接受胰岛素治疗、筛查 GHb <12.0% 的 I 型糖尿病受试者中进行。 HOE901和NPH人胰岛素的功效比较将基于GHb水平。 GHb 测量是临床上评估糖尿病血糖控制的有用方法。 GHb 值反映了过去 2-3 个月的血糖水平。 对于次要目标，将比较两个治疗组之间的空腹血糖、空腹血糖变异性、低血糖和药物经济学。 将根据临床事件分析、标准临床事件、标准临床化学和血液学结果以及大肠杆菌抗体和胰岛素抗体的测定来评估安全性。