临床试验/NCT01467401

NCT01467401已完成4 期

A Multi-National, Multi-Centre, Randomised, Open-Labelled, Parallel Trial Comparing Efficacy and Safety of NovoMix® 30 FlexPen® and Mixtard® 30 Twice Daily Injections in Subjects With Type 2 Diabetes

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 292 人开始时间: 2002年8月19日最近更新: 2017年2月24日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 292
试验地点: 1
主要终点: HbA1c (glycolated haemoglobin)

研究概览研究设计入排标准研究组 & 干预措施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 Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in 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: None

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

•Type 2 diabetes for at least 24 months
•Insulin treatment for the pase 3 months
•HbA1c (glycosylated haemoglobin) below 13%
•BMI (Body Mass Index) below 40 kg/m^2
•Ability and willingness to perform self-blood glucose monitoring

排除标准

•Receipt of any investigational drug within 4 weeks prior to this trial
•Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial
•Total daily insulin dosage less than or equal to 1.8 IU/kg

研究组 & 干预措施

A

Experimental

干预措施: biphasic insulin aspart (Drug)

B

Active Comparator

干预措施: biphasic human insulin (Drug)

结局指标

主要结局

HbA1c (glycolated haemoglobin)

次要结局

Number and severity of hypoglycaemic episodes
7-point blood glucose profile
Number and severity of local tolerability issues at the injection site
Prandial increment in blood glucose
Number and severity of adverse events

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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