NCT01345734已完成不适用
Liraglutide Effectiveness and Safety Data From Routine Clinical Practice in Philippines Study. A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes Mellitus in Philippines
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
- 1,056
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse drug reactions (SADRs)
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to investigate the safety profile of liraglutide under normal conditions of use.
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 or those already receiving other anti-diabetic medications including GLP-1 analogues other than Liraglutide, 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 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
Liraglutide
干预措施: liraglutide (Drug)
结局指标
主要结局
Incidence of serious adverse drug reactions (SADRs)
时间窗: Week 0, week 26
次要结局
- Incidence of adverse drug reactions (ADRs)(Week 0, week 26)
- Incidence of serious adverse events (SAEs)(Week 0, week 26)
- Change in HbA1c (glycosylated haemoglobin)"(Week 0, week 26)
- Frequency of hypoglycaemic episodes(Week 0, week 26)
研究者
研究点 (1)
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