NCT06807190招募中不适用
A Multi-centre, Prospective, Open Label, Non-interventional, Single-armed, 52 Weeks Post-marketing Study to Investigate Safety and Clinical Parameters of Awiqli Once Weekly in Patients With Diabetes Mellitus Under Real-world Clinical Practice Setting in Japan
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 630
- 试验地点
- 178
- 主要终点
- Number of Adverse Reactions (ARs)
研究概览
简要总结
The purpose of the study is to investigate the safety and effectiveness of Awiqli in participants with diabetes mellitus under real world clinical practice in Japan. Participants will get Awiqli as prescribed by the study doctor. The study will last for about 1 year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 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 Awiqli 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 with no age limitation.
- •Diagnosis of diabetes mellitus. There is no limitation for type of diabetes mellitus and prior treatment for diabetes mellitus.
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Treatment with any investigational drug within 30 days prior to enrolment into the study.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •Contraindication described in Japanese package insert.
- •Participants showing hypoglycaemic symptoms.
- •Participants with a history of hypersensitivity to any ingredients of this drug.
研究组 & 干预措施
Awiqli
Participants with diabetes mellitus will be treated with commercially available Awiqli according to routine clinical practice at the discretion of the treating physician.
干预措施: Insulin Icodec (Drug)
结局指标
主要结局
Number of Adverse Reactions (ARs)
时间窗: From baseline (week 0) to end of study (week 52)
Measured as number of events.
次要结局
- Number of Adverse Events (AEs)(From baseline (week 0) to end of study (week 52))
- Number of Serious Adverse Events (SAEs)(From baseline (week 0) to end of study (week 52))
- Number of Serious Adverse Reactions (SARs)(From baseline (week 0) to end of study (week 52))
- Change in Glycosylated Haemoglobin (HbA1c)(From baseline (week 0) to end of study (week 52))
- Change in Fasting Plasma Glucose (FPG)(From baseline (week 0) to end of study (week 52))
- Change in Diabetes Therapy-Related Quality Of Life (DTR-QOL)(From baseline (week 0) to end of study (week 52))
研究者
研究点 (178)
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