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临床试验/NCT00154414
NCT00154414已完成2 期

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

Novo Nordisk A/S2 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2005年1月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
226
试验地点
2
主要终点
HbA1c

研究概览

简要总结

This trial is conducted in Japan. The aim of this research trial is to evaluate the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in Japanese 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
20 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects diagnosed with type 2 diabetes and treated with diet therapy with or without single oral drug therapy
  • 7.0 % =< HbA1c < 10.0 %
  • Body Mass Index (BMI) < 30.0 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.
  • Glycaemic control parameters (fasting plasma glucose, post prandial plasma glucose) after 14-week treatment
  • Safety and tolerability

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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