临床试验/NCT00476437

NCT00476437已完成3 期

Safety and Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Human Insulin 50 in Patients With Type 2 Diabetes Mellitus.

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 81 人开始时间: 2007年4月1日最近更新: 2023年11月2日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 81
试验地点: 1
主要终点: Incidence of hypoglycaemic episodes

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Japan. The purpose of this trial is to investigate the safety and the effect of biphasic insulin aspart 50 compared to biphasic human insulin 50 in patients with type 2 diabetes mellitus.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 20 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Type 2 diabetes mellitus
•Current treatment with pre-mixed human insulin preparation or biphasic/pre-mixed insulin analogue in twice daily treatment for at least 8 weeks.
•HbA1C: less than 11.0%
•BMI: less than 30.0 kg/m2

排除标准

•Total daily insulin dose: 100 IU/U and more
•Treatment with oral hypoglycaemic agents within the last 4 weeks.
•Treatment with insulin sensitizer within the last 12 weeks
•A lifestyle that is considered unsuitable for this trial (frequent or routine night shift workers etc.)

结局指标

主要结局

Incidence of hypoglycaemic episodes

时间窗: During 16 weeks of treatment

次要结局

未报告次要终点

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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