NCT01484262已完成不适用
Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2
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
- 1,344
- 试验地点
- 1
- 主要终点
- Diabetes-related quality of life assessed by ADDQoL (Audit of Diabetes-Dependent Quality of Life)
研究概览
简要总结
This study is conducted in Europe. The intention of this health service research study is to obtain data from daily routine to evaluate the quality of life and the costs of the disease for patients 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
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any study-related activities. (Study-related activities are any procedures related to recording of data according to the protocol)
- •Patients willing and able to give signed consent on matching patient data with sick fund data
- •Patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetic medication, who need treatment intensification with insulin or liraglutide (Victoza®) due to inadequate blood glucose control
- •Patient is a member of the involved sick fund (AOK Plus)
排除标准
- •Known or suspected contra-indication to the relevant study product according to current SPC
- •Previous participation in this study
- •History of type 1 diabetes mellitus
- •Previous insulin treatment excluding emergency administration (treatment duration up to a maximum of 3 days)
- •Previous treatment with liraglutide
- •History of diabetic gastroparesis, diabetic precoma or diabetic ketoacidosis
- •Progressive fatal disease
- •Any reason in judgement of the treating physician that precludes study participation e.g. lack of compliance, safety concerns, alcohol or drug abuse
- •Patients without legal capacity
研究组 & 干预措施
Liraglutide
干预措施: liraglutide (Drug)
Any insulin
干预措施: insulin (Drug)
结局指标
主要结局
Diabetes-related quality of life assessed by ADDQoL (Audit of Diabetes-Dependent Quality of Life)
时间窗: At the end of the observational period (52 weeks)
次要结局
- Total cost of patient's diseases(At the end of the observational period (52 weeks))
- Total cost of patient education(At the end of the observational period (52 weeks))
研究者
研究点 (1)
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