NCT03416855已完成不适用
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance(rPMS) Study of Ryzodeg® FlexTouch® (Insulin Degludec /Insulin Aspart) to Evaluate Safety and Effectiveness in Patients 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
- 768
- 试验地点
- 1
- 主要终点
- Number of Adverse events (AEs) at week 13
研究概览
简要总结
The purpose of this study is to collect information about safety and effectiveness of Ryzodeg® FlexTouch® in participants with diabetes mellitus requiring insulin therapy under routine clinical practice conditions with the aim of identifying or quantifying a safety hazard, early detection of unknown safety problems. Participants will attend the clinic/hospital/medical institution according to usual practice and receive medical care, as agreed with the 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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The decision to initiate treatment with commercially available Ryzodeg® 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 - Signed informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study - Age equals to or more than 2 years at the time of signing informed consent with diabetes mellitus (Type 1 or Type 2) and who is scheduled to start treatment with Ryzodeg® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (K-PI)
排除标准
- •Patients who are or have previously been on Ryzodeg® FlexTouch® therapy - Known or suspected hypersensitivity to Ryzodeg® FlexTouch®, the active substance or any of the excipients - Previous participation in this study. Participation is defined as having given informed consent in this study - Female patient who is pregnant, breast-feeding or intends to become pregnant and is of childbearing potential and not using adequate contraceptive methods(adequate contraceptive measures as required by Korea regulation or practice) - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
研究组 & 干预措施
Overall population
Participants will be decided to be treated with Ryzodeg® FlexTouch® by physicians before the enrolment in the study based on clinical judgement in the diabetes management.
干预措施: Insulin degludec /insulin aspart (Drug)
结局指标
主要结局
Number of Adverse events (AEs) at week 13
时间窗: week 13 (± 2 weeks)
Count of events
Number of patients with AEs at week 26
时间窗: week 26 (± 2 weeks)
Number of patients
Number of patients with AEs at week 13
时间窗: week 13 (± 2 weeks)
Number of patients
Percentage of patients with AEs at week 26
时间窗: week 26 (± 2 weeks)
Percentage of patients
Percentage of patients with AEs at week 13
时间窗: week 13 (± 2 weeks)
Percentage of patients
Number of Adverse events (AEs) at week 26
时间窗: week 26 (± 2 weeks)
Count of events
次要结局
- Percentage of Patients with ADR at week 13(week 13 (± 2 weeks))
- Percentage of patients with unexpected ADR at week 26(week 26 (± 2 weeks))
- Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13(week 13 (± 2 weeks))
- Number of patients with Adverse Drug Reaction (ADR) at week 13(week 13 (± 2 weeks))
- Number of patients with Serious AE/ADR at week 13(week 13 (± 2 weeks))
- Percentage of patients with Serious AE/ADR at week 13(week 13 (± 2 weeks))
- Percentage of patients with Serious AE/ADR at week 26(week 26 (± 2 weeks))
- Change from baseline in HbA1c after 13 weeks of treatment(week 0, week 13 (± 2 weeks))
- Number of Patients with ADR at week 26(week 26 (± 2 weeks))
- Percentage of Patients with ADR at week 26(week 26 (± 2 weeks))
- Number of patients with Serious AE/ADR at week 26(week 26 (± 2 weeks))
- Number of patients with unexpected ADR at week 13(week 13 (± 2 weeks))
- Percentage of patients with unexpected ADR at week 13(week 13 (± 2 weeks))
- Number of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26(week 26 (± 2 weeks))
- Number of subjects with unexpected ADR at week 26(week 26 (± 2 weeks))
- Number of patients with Severe or Blood Glucose (BG) confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13(week 13 (± 2 weeks))
- Change from baseline in FBG/FPG after 26 weeks treatment(week 0, week 26 (± 2 weeks))
- Change from baseline in body weight at week 13(week 0, week 13 (± 2 weeks))
- Percentage of patients achieving the target of HbA1c < 7.0% at 13 weeks of treatment(week 13 (± 2 weeks))
- Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26(week 26 (± 2 weeks))
- Change from baseline in body weight at week 26(week 0, week 26 (± 2 weeks))
- Insulin dose at week 13(week 13 (± 2 weeks))
- Insulin dose at week 26(week 26 (± 2 weeks))
- Percentage of patients achieving the target of HbA1c < 7.0% at 26 weeks of treatment(week 26 (± 2 weeks))
- Change from baseline in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) after 13 weeks treatment(week 0, week 13 (± 2 weeks))
- Changes from baseline in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) after 13 weeks treatment(week 0, week 13 (± 2 weeks))
- Changes from baseline in PPBG/PPPG after 26 weeks treatment(week 0, week 26 (± 2 weeks))
- Change from baseline in HbA1c after 26 weeks of treatment(week 0, week 26 (± 2 weeks))
研究者
研究点 (1)
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