NCT03888157已完成不适用
A Multi-centre, Prospective, Non-interventional Study Investigating the Effect of Victoza® in Patients With Type 2 Diabetes in Iran Followed in a Real World Setting
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
- 839
- 试验地点
- 1
- 主要终点
- Change in HbA1c (mmol/mol)
研究概览
简要总结
The purpose of the study is to collect information on how the medicine Victoza® (liraglutide) works in people with Type 2 diabetes in Iran. Patients will get Victoza® as prescribed to them by their study doctor. The study will last for about 5 to 8 months. Patients will be asked to complete some questionnaires about their health and diabetes treatment. Patients will complete these during their normally scheduled visits with study doctor.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
- •Male or female, age greater than or equal to 18 years at the time of signing informed consent
- •The decision to initiate treatment with commercially available Victoza® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study
- •Patients diagnosed with type 2 diabetes mellitus (T2DM), with treatment planned according to the Iranian label for Victoza® at treatment initiation
- •Available glycated haemoglobin A1c (HbA1c) value less than or equal to 12 weeks prior to initiation of treatment with Victoza®
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study
- •Known or suspected hypersensitivity to Victoza® or related products
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
研究组 & 干预措施
Liraglutide
Patients with type 2 diabetes in Iran are to receive Victoza® for 26 weeks.
干预措施: Liraglutide (Drug)
结局指标
主要结局
Change in HbA1c (mmol/mol)
时间窗: Week 0, week 26
Measured in mmol/mol.
Change in glycated haemoglobin A1c (HbA1c) (percentage)
时间窗: Week 0, week 26
Measured in percentage.
次要结局
- Change in body weight (percentage)(Week 0, week 26)
- Change in body weight (kilogram)(Week 0, week 26)
- Change in fasting blood glucose (FBG) (self-measured)(Week 0, week 26)
- Change in total cholesterol (TC)(Week 0, week 26)
- Change in low density lipoprotein cholesterol (LDL-C)(Week 0, week 26)
- Change in waist circumference(Week 0, week 26)
- Change in high density lipoprotein cholesterol (HDL-C)(Week 0, week 26)
- Number of patients permanently discontinuing treatment with Victoza®(Week 26)
- Reasons for permanent treatment discontinuations(Week 26)
- Change in triglyceride (TG)(Week 0, week 26)
- Change in free fatty acid (FFA)(Week 0, week 26)
- Changes in quality of life (EQ VAS)(Week 0, week 26)
- Changes in quality of life (EQ-5D index score)(Week 0, week 26)
研究者
研究点 (1)
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