NCT07658417Enrolling By Invitation不适用
A Real-world, Multi-centre, Prospective, Non-interventional, Single-arm Study Investigating Glycaemic Control, Treatment Satisfaction and Adherence Associated With the Switch From Daily Basal Insulin to Insulin Icodec in People Living With Type 2 Diabetes in China
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 216
- 试验地点
- 15
- 主要终点
- Change in glycated haemoglobin (HbA1c)
研究概览
简要总结
The purpose of this study is to investigate the use of insulin icodec in the real-world setting in a population that broadly reflects people living with T2D and for whom switching to a once-weekly insulin icodec has been deemed relevant and beneficial by the treating physician. The study will last for approximately 30 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
- 18 Years 至 —（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 protocol).
- •The decision to initiate treatment with commercially available insulin icodec has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include participant in this study.
- •Male or female, age above or equal to 18 years at the time of signing informed consent.
- •Diagnosed with T2D greater than or equal to (≥) 1 year before signing informed consent.
- •Treated with once- or twice-daily basal insulin injections ≥ 6 months before signing informed consent. Any other antidiabetic medications are allowed, except for bolus insulin during the 90 days prior to switching to icodec for a period of 14 days or more.
- •Available glycated haemoglobin (HbA1c) within 90 days prior to the 'Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Initiation visit' (V1) if in line with local clinical practice.
- •Treatment-naïve to once-weekly insulin prior to the 'Initiation Visit' (V1)
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 study.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
研究组 & 干预措施
Icodec with/without non-insulin glucose lowering treatments
Participants will initiate the treatment with insulin icodec at the treating physician's discretion according to the local label, and it will be clearly separated from the decision to include the participant in the study.
干预措施: Insulin icodec (Drug)
结局指标
主要结局
Change in glycated haemoglobin (HbA1c)
时间窗: From baseline (week 0) to week 26
Measured in percentage (%)-point
次要结局
- Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score(From baseline (week 0) to End of study (week 22-30))
- Change in Adelphi Adherence Questionnaire (ADAQ) score(From baseline (week 0) to End of study (week 22-30))
- Change in body weight(From baseline (week 0) to week 26)
- Number of self-reported overall severe hypoglycemia episodes(From baseline (week 0) to end of study (week 22-30))
研究者
研究点 (15)
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