临床试验/NCT00564668

NCT00564668已完成3 期

A 24-week, Randomised, Multi-centre, Double-blind, Parallel-group Trial to Investigate the Safety and the Efficacy of NN2000-Mix30 Compared to NN-X14Mix30 NovoRapid®30Mix) in Subjects With Type 2 Diabetes Mellitus on a Twice Daily Regimen

Novo Nordisk A/S2 个研究点分布在 1 个国家目标入组 126 人开始时间: 2004年6月19日最近更新: 2017年3月1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: 126
试验地点: 2
主要终点: Safety

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 aim of this trial was to investigate the safety and efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced by current process in Japanese subjects with type 2 diabetes.

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: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subjects with type 2 diabetes
•Subjects with insulin treatment for at least 24 weeks
•Current treatment with premixed biphasic human insulin preparation for at least 12 weeks
•HbA1c lesser than or equal to 11.0%

排除标准

•Recurrent severe hypoglycaemia
•Proliferative retinopathy or maculopathy requiring acute treatment
•Impaired renal function
•Cardiac diseases
•Uncontrolled hypertension
•Subjects with known malignant tumour
•Total daily insulin dose greater than or equal to 100 IU

结局指标

主要结局

Safety

时间窗: During 24 weeks of treatment

次要结局

HbA1c

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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