NCT04952779已完成不适用
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec / Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 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
- 750
- 试验地点
- 31
- 主要终点
- Incidence of Adverse Events (AEs) by preferred term
研究概览
简要总结
The aim of this study is to assess the safety and effectiveness of Xultophy® initiated according to label in adults with type 2 diabetes mellitus (T2DM) under routine clinical practice conditions. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26 weeks.
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
- 19 Years 至 —（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 Xultophy® has been made by the participant/Legally Acceptable Representative (LAR) and the study doctor before and independently from the decision to include the participant in this study.
- •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.
- •Male or female, age 19 years or older at the time of signing informed consent form.
- •Participants diagnosed (clinically) with T2DM and who is scheduled to start treatment with Xultophy® based on the clinical judgment of their treating physician as specified in the approved Korean-Prescribing information (local label).
排除标准
- •Participants who are or have previously been on Xultophy® therapy.
- •Known or suspected hypersensitivity to Xultophy® (the active substance or any of the excipients).
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
研究组 & 干预措施
Xultophy®
Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea.
干预措施: Xultophy® (insulin degludec/liraglutide) (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs) by preferred term
时间窗: baseline (Visit1, 0 week) to 26 weeks
Count of events
次要结局
- Change in Glycosylated Haemoglobin (HbA1c)(Visit 1 (0 week), Visit 3 (13 weeks))
- Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia(Visit1 (0 week) to 26 weeks)
- Change in body weight(Visit 1 (0 week), Visit 4 (26 weeks))
- Change of Xultophy® dose(Visit (0 week), Visit 4 (26 weeks))
- Change in HbA1c(Visit 1 (0 week), Visit 4 (26 weeks))
- Individuals achieving HbA1c target less than 7.0 %(Visit 1 (0 week), Visit 4 (26 weeks))
- Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)(Visit 1 (0 week), Visit 4 (26 weeks))
- Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)(Visit 1 (0 week), Visit 3 (26 weeks))
研究者
研究点 (31)
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