临床试验/NCT00184626

NCT00184626已完成4 期

Safety and Efficacy of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin 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 97 人开始时间: 2004年9月10日最近更新: 2017年2月24日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 97
试验地点: 1
主要终点: HbA1c

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 Asia. The aim of the trial is to compare the glycaemic control of Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in combination with metformin 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: 35 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Type 2 diabetes
•Body mass index equal to or lesser than 35.0 kg/m2
•Currently treated with oral hypoglycaemic drug

排除标准

•Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
•Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or evaluation of results

结局指标

主要结局

HbA1c

时间窗: Measured at end of treatment (26 weeks)

次要结局

safety variables
other glycemic variables
Fasting plasma glucose value

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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