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

本研究的目的是比较HOE901与NPH人胰岛素在I型糖尿病患者中与胰岛素利斯普罗联合使用16周的疗效和安全性。本研究将在1型糖尿病患者中进行，接受胰岛素治疗，筛查GHb <12.0%。HOE901和NPH人胰岛素在疗效方面的比较将基于GHb水平。GHb的测量是评估糖尿病患者血糖控制的一种临床有用的手段。GHb值反映前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。安全性将根据临床事件、标准临床事件、标准临床化学和血液学结果的分析以及大肠杆菌抗体和胰岛素抗体的测定来评估。

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.