Glycaemic Control and Management in Adult Type 2 Diabetes Patients Previously Treated With Premix Insulins and Initiating Treatment With IDegLira in Routine Clinical Practice in Croatia: A 36-week Single Arm, Prospective, Multi-centre, Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Glycated Haemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to look at the blood sugar control in participants with type 2 diabetes previously treated with premix insulins and initiating treatment with IDegLira. Participants will get IDegLira as prescribed by study doctor regardless of participant's decision to participate in the study. Decision to initiate treatment with IDegLira will be made by study doctor independent from the study. The study will last for about 36 weeks. Participants will be asked questions about their health and diabetes treatment and lab tests as part of their normal doctor's appointment.
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).
- •Male or female patients aged greater than or equal to (>=) 18 years at the time of signing informed consent.
- •Patients diagnosed with T2D and receiving treatment with premix insulin for at least 12 weeks (3 months) based on local clinical guidelines.
- •Switched to treatment with IDegLira from previous treatment of premix insulins. The decision to initiate treatment with IDegLira must be independently from the decision to enrol in the study.
- •Available and documented HbA1c collected within 12 weeks prior to initiation of IDegLira.
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Participation in any other T2D clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to initiation of IDegLira.
- •Previous treatment with IDegLira.
- •Patients diagnosed with Type 1 diabetes mellitus.
- •Female who is known to be pregnant, breastfeeding or intends to become pregnant during the conduct of the study.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the IDegLira label in Croatia.
研究组 & 干预措施
Participants with type 2 diabetes (T2D)
Participants with T2D previously treated with premix insulin for at least 12 weeks (3 months) based on local clinical guidelines will initiate treatment with IDegLira at the treating physician's discretion according to the approved IDegLira label in Croatia.
干预措施: IDegLira (Drug)
结局指标
主要结局
Change in Glycated Haemoglobin A1c (HbA1c)
时间窗: From baseline to end of study (week 36 ± 6 weeks)
Measured in percentage (%) point.
次要结局
- Change in body weight(From baseline to end of study (week 36 ± 6 weeks))
- Number of participants with HbA1c less than (<) 7.0%(At end of study (week 36 ± 6 weeks))
- Starting dose of IDegLira(At baseline)
- Dose of IDegLira at end of study(At end of study (week 36 ± 6 weeks))