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临床试验/NCT01212133
NCT01212133已完成不适用

A Post Marketing Surveillance (PMS) Study of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 1,386 人开始时间: 2010年11月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,386
试验地点
1
主要终点
The number of serious adverse drug reactions (SADRs) during the study period
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 study is conducted in Asia. The aim of this study is to evaluate the safety and effectiveness of liraglutide in subjects with type 2 diabetes mellitus.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Subjects with type 2 diabetes, including newly-diagnosed patients / those already receiving other anti-diabetic medications including GLP-1 analogues, who require treatment with liraglutide according to the clinical judgment of their treating physician
  • •Subjects who are capable of giving study-specific signed informed consent before any collection of information

排除标准

  • •Subjects with type 1 diabetes
  • •Subjects who are or have previously been on liraglutide
  • •Subjects who have previously been enrolled in the study
  • •Subjects who are participating in another clinical trial
  • •Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
  • •Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months

研究组 & 干预措施

A

干预措施: liraglutide (Drug)

结局指标

主要结局

The number of serious adverse drug reactions (SADRs) during the study period

时间窗: during 26 weeks of treatment

次要结局

  • Frequency of hypoglycaemic episodes(during 26 weeks of treatment)
  • The number of adverse drug reactions (ADR) during the study period(during 26 weeks of treatment)
  • The number of serious adverse events (SAE) during the study period(during 26 weeks of treatment)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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