NCT07632404Enrolling 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 Italy
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
- 214
- 试验地点
- 16
研究概览
简要总结
The study will look at how well insulin icodec controls blood sugar levels in participants who have never used it before. Participants with type 2 diabetes (T2D) will be treated with insulin icodec as prescribed to by their doctor, in accordance with usual clinical practice. This study will last for about 22 to 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 the 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 the 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 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 the study.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
研究组 & 干预措施
Insulin icodec
Participants with T2D will be treated with commercially available insulin icodec according to routine clinical practice at the discretion of the treating physician.
干预措施: Insulin icodec (Drug)
研究者
研究点 (16)
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