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临床试验/NCT00154401
NCT00154401已完成2 期

Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes.

Novo Nordisk A/S40 个研究点 分布在 4 个国家目标入组 177 人开始时间: 2005年1月最近更新:
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试验速览

阶段
2 期
状态
已完成
入组人数
177
试验地点
40
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 Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.

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 diagnosed with type 2 diabetes mellitus and treated with either diet or single oral drug therapy
  • •Diet treated subjects: 7.5% < HbA1c < 10%
  • •Single oral drug therapy subjects: 7.0% < HbA1c < 9.5%
  • •Body Mass Index (BMI): max 40 kg/m^2

排除标准

  • •Subjects treated with thiazolidinediones or insulin
  • •Subjects with any serious medical conditions

结局指标

主要结局

HbA1c

时间窗: after 14 weeks treatment

次要结局

  • Body weight after 14 weeks.
  • Safety and tolerability
  • Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks.

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (40)

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