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

人胰岛素类似物ho901的开发是为了满足医学对长效胰岛素的需求，这种胰岛素可以每天注射一次，使血糖控制在正常或接近正常水平，同时在24小时内胰岛素的基础分布尽可能平稳。这种制剂应能更好地控制夜间血糖和空腹血糖水平，以及更稳定的日间血糖谱。本研究的目的是比较ho901与NPH人胰岛素的疗效和安全性。该研究将在接受NPH和常规人胰岛素多剂量胰岛素治疗的1型糖尿病患者中进行。HOE 901和NPH人胰岛素的疗效比较将基于糖蛋白（GHb）水平。除了这一主要目的外，还将比较两个治疗组之间的血糖变异性、其他代谢控制指标和生活质量。安全性将通过实验室结果和临床事件分析来评估。

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.