NCT01288326已完成不适用
A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1%
研究概览
简要总结
The study is conducted in Europe. The aim of this observational study is to assess glycaemic control while using liraglutide under normal clinical practice conditions in Belgium.
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
- •Type 2 diabetes
- •Insufficiently controlled after 3 months of treatment with OADs (oral anti-diabetic drugs)
排除标准
- •Previously treated with liraglutide
- •Hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
- •Pregnant, breast feeding or have the intention of becoming pregnant
研究组 & 干预措施
A
干预措施: liraglutide (Drug)
结局指标
主要结局
Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1%
时间窗: month 12
Percentage of participants reaching the treatment target of a HbA1c (glycosylated haemoglobin A1c) decrease of at least 1%
时间窗: month 12
次要结局
- Incidence of adverse drug reactions (ADRs)(months 0-12)
- Fasting blood glucose (FBG)(month 12)
- Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar)(months 0-12)
- HbA1c(month 12)
- Incidence of serious adverse events (SAEs)(months 0-12)
研究者
研究点 (1)
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