28 WEEK MULTI CENTER CONTROLLED RANDOMIZED OPEN CLINICAL TRIAL COMPARING HOE

人胰岛素类似物hoe 901是为满足医学需要而开发的。 一种长效胰岛素，可以作为每日一次给药 注射使血糖控制在正常或接近正常的水平 基础胰岛素谱在24小时内尽可能平稳。 这种制剂应该能更好地控制夜间血糖，并 空腹血糖水平和更稳定的白天血糖 侧写。 本研究的目的是比较HOE 901的疗效和安全性。 与NPH人胰岛素相同。 这项研究将在患有1型糖尿病的患者中进行，这些患者 使用NPH和常规人胰岛素进行多剂量胰岛素治疗。 HOE 901与NPH人胰岛素的疗效比较 以糖化血红蛋白(GHb)水平为基础。除了这场初选 目标、血糖变异性、其他代谢指标 对照，并将两种治疗方法的生活质量进行比较 组。安全性将通过实验室发现和分析进行评估 临床事件的记录。

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.