NCT01403025已完成不适用
A Multi-centre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Victoza® in Subjects With Type 2 Diabetes Mellitus
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
- 4,121
- 试验地点
- 1
- 主要终点
- The incidence of SADRs (Serious Adverse Drug Reactions)
研究概览
简要总结
This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions).
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 mellitus, including newly-diagnosed subjects, who require treatment with liraglutide
排除标准
- •Subjects who are or have previously been on liraglutide
- •Subjects who have previously been enrolled in the study
- •Subjects with a hypersensitivity to liraglutide or to any of the excipients
- •Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods
- •Subjects with cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the trial
- •Known or suspected abuse of alcohol or narcotics
研究组 & 干预措施
Liraglutide
干预措施: liraglutide (Drug)
结局指标
主要结局
The incidence of SADRs (Serious Adverse Drug Reactions)
时间窗: After 36 months
次要结局
- The incidence rate and type of SAEs (Serious Adverse Events)(At month 1, 3, 6, 12, 24 and 36)
- The incidence rate and type of ADRs (Adverse Drug Reactions)(At month 1, 3, 6, 12, 24 and 36)
研究者
研究点 (1)
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