NCT02779413已完成不适用
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Tresiba® FlexTouch® (Insulin Degludec) to Evaluate Safety and Effectiveness in Patients of All Age Groups Excluding Less Than 12 Months Old Infants With Diabetes Mellitus in Routine Clinical Practice in Korea
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
- 3,303
- 试验地点
- 1
- 主要终点
- Number of Adverse Events (AE)
研究概览
简要总结
This study is conducted in Asia. The aim of the study is to evaluate safety and effectiveness in patients of all age groups excluding less than 12 month old infants with diabetes mellitus in routine clinical practice in Korea.
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
- 12 Months 至 —（Child, 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) - The decision to initiate treatment with commercially available Tresiba® FlexTouch® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study - Male or Female, Age at least 12 months, at the time of signing informed consent with type 1 or type 2 diabetes mellitus and who is scheduled to start treatment with Tresiba® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing Information (KPI)
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study - Patients who are or have previously treated with Tresiba® FlexTouch® - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. However, paediatric patients can be enrolled when the patient's primary caregiver (e.g. parents) or legally acceptable representatives (LAR) are capable of giving study specific signed informed consent. Any chronic disorder or severe disease which in the opinion of the investigator might jeopardise patient's safety or compliance with the protocol - Female who is pregnant, breast-feeding or intends to become pregnant and is of child-baring potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
研究组 & 干预措施
Insulin degludec
干预措施: insulin degludec (Drug)
结局指标
主要结局
Number of Adverse Events (AE)
时间窗: week 26± 2 weeks
次要结局
- Number of Adverse reactions (AR)(week 26± 2 weeks)
- Number of Serious AE(week 26± 2 weeks)
- Number of Serious AR(week 26± 2 weeks)
- Number of Unexpected AR(week 26± 2 weeks)
- Number of Severe hypoglycaemia (PG (plasma glucose) below 56 mg/dl)(week 26± 2 weeks)
- Insulin dose changes(Week 0, Week 26)
- Number of Blood glucose (BG) confirmed hypoglycaemia (PG below 56 mg/dl)(week 26± 2 weeks)
- Change in HbA1c(Week 0, week 13, week 26)
- Percentage of patients achieving the target of HbA1c below 7.0%(At week 26)
- Change in fasting plasma glucose (FPG)(Week 0, week 13, week 26)
- Changes in postprandial plasma glucose (PPG)(Week 0, week 13, week 26)
- Weight gain(week 26± 2 weeks)
研究者
研究点 (1)
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