NCT02392117已完成不适用
A Multi-centre, Prospective, Non-interventional Study of Insulin Degludec Investigating the Safety and Effectiveness in a Real World Population With Type 1 and 2 Diabetes Mellitus
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
- 1,262
- 试验地点
- 1
- 主要终点
- Change in the number of any hypoglycaemic episodes
研究概览
简要总结
This study is conducted in Europe. The aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) 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 —（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 procedure related to recording of data according to the protocol)
- •Male or female patients at least 18 years of age at time of informed consent
- •T1DM (diagnosed clinically) prior to inclusion in the study, and/or T2DM, insulin using patients (diagnosed clinically) prior to inclusion in the study
- •Planned initiation with Tresiba®
排除标准
- •Known or suspected hypersensitivity to Tresiba® or any of the excipients listed in Section 6.1 of the SmPC (Summary of Product Characteristics) or related products
- •Previous participation in this study (i.e. provision of informed consent)
- •Patients who have previously been treated with Tresiba®
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
研究组 & 干预措施
Insulin degludec
干预措施: insulin degludec (Drug)
结局指标
主要结局
Change in the number of any hypoglycaemic episodes
时间窗: End of 4 week baseline period, end of 12 month observation period
次要结局
- Change from baseline in HbA1c (glycosylated haemoglobin)(0- 12 months)
- Change from baseline in FPG (Fasting Plasma Glucose)(0-12 months)
- Change from the baseline period in the number of severe hypoglycaemic episodes(0-12 months)
- Change from baseline in HR-QoL (health-related quality of life) questionnaire scores (PROs (patient reported outcome): SF-36 (short form 36), and DTSQ(Diabetes Treatment Satisfaction Questionnaire ))(0-12 months)
研究者
研究点 (1)
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