NCT05473286撤回不适用
A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Germany
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Glycated haemoglobin (HbA1c )
研究概览
简要总结
The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 34-44 weeks. Participants will be asked to complete questionnaires about how they take their Rybelsus® tablets. Participants will complete the questionnaires during their normally scheduled visit with the study doctor.
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).
- •Diagnosed with type 2 diabetes mellitus.
- •The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
- •Male or female, age above or equal to 18 years at the time of signing informed consent.
- •Available HbA1c value less than or equal to (≤) 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice.
- •Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than (<) 14 days.
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
Patients with type 2 diabetes
Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.
干预措施: Oral Semaglutide (Drug)
结局指标
主要结局
Change in Glycated haemoglobin (HbA1c )
时间窗: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Percent-points.
次要结局
- Absolute change in body weight(From baseline (week 0) to End of Study visit (V3) (week 34-44))
- HbA1c reduction >=1%-points and body weight reduction of >=3% (Yes/No)(From baseline (week 0) to End of Study visit (V3) (week 34-44))
- Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction(End of Study visit (V3) (week 34-44))
- Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction(From baseline (week 0) to End of Study visit (V3) (week 34-44))
- Relative change in body weight(From baseline (week 0) to End of Study visit (V3) (week 34-44))
- HbA1c <7% (Yes or No)(End of Study visit (V3) (week 34-44))
- HbA1c reduction >=1%-points and body weight reduction of >=5% (Yes/No)(From baseline (week 0) to End of Study visit (V3) (week 34-44))
研究者
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