NCT01821846已完成不适用
A 6-month, Multi-centre, Open Labelled, Non-randomized, Non-interventional, Safety Study of Liraglutide (Victoza®) in Subjects With Type 2 Diabetes Mellitus in Korea
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
- 64
- 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 this study is to investigate the safety profile of liraglutide (Victoza®) under normal conditions of use in Korean 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 T2DM (Type 2 Diabetes Mellitus), including newly-diagnosed subjects, who require treatment with Victoza® according to the clinical judgment of their treating physician
- •Subjects (and/or parents or the subject's legally acceptable representative) who are capable of giving study-specific signed informed consent before any collection of information
排除标准
- •Subjects with a hypersensitivity to Victoza® 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 personal or family history of medullary thyroid carcinoma (MTC)
- •Subjects with multiple endocrine neoplasia syndrome type 2 (MEN2)
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: Up to 6 months
次要结局
- Change in body weight(Month 0, month 6)
- HbA1c (Glycosylated haemoglobin) change(Month 0, month 6)
- Number of SAEs/ ADRs (Serious Adverse Events/Adverse Drug Reactions)(Up to 6 months)
- Percentage of subjects reaching the target of HbA1c below 7.0%(Month 6)
研究者
研究点 (1)
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