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

人类胰岛素类似物HOE 901是为了满足医学上对长效胰岛素的需要而开发的，这种胰岛素可以作为每天一次注射，以产生正常或接近正常的血糖控制，并在24小时内尽可能平稳地保持基础胰岛素谱。这种制剂应该可以更好地控制夜间血糖和空腹血糖水平，并提供更稳定的白天血糖曲线。本研究的目的是比较HOE 901和NPH人胰岛素的有效性和安全性。这项研究将在1型糖尿病患者中进行，他们正在接受使用NPH和常规人类胰岛素的多剂量胰岛素治疗。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。除了这一主要目标外，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。安全性将通过实验室结果和对临床事件的分析进行评估。

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.