NCT04862923已完成不适用
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 the United Kingdom
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 1
- 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 by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor. Participants will be asked to complete some questionnaires about their diabetes treatment. Participants will complete these during their normally scheduled visits 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 glycated haemoglobin (HbA1c) value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (Visit 1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (Visit 1) 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 14 days or less.
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 (Visit 3) (week 34-44)
percent-points
次要结局
- HbA1c less than 7 percent (Yes/No)(End of Study visit (Visit 3) (week 34-44))
- HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 3 percent (Yes/No)(From baseline (week 0) to End of Study visit (Visit 3) (week 34-44))
- Relative change in body weight(From baseline (week 0) to End of Study visit (Visit 3) (week 34-44))
- Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction(End of Study visit (Visit 3) (week 34-44))
- Absolute change in body weight(From baseline (week 0) to End of Study visit (Visit 3) (week 34-44))
- HbA1c reduction greater than or equal to 1 percent-points and body weight reduction greater than or equal to 5 percent (Yes/No)(From baseline (week 0) to End of Study visit (Visit 3) (week 34-44))
- Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction(From baseline (week 0) to End of Study visit (Visit 3) (week 34-44))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Mexico, as Part of Local Clinical PracticeDiabetes Mellitus, Type 2NCT05316662Novo Nordisk A/S187
已完成
不适用
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in The Netherlands, as Part of Local Clinical PracticeDiabetes Mellitus, Type 2NCT04601740Novo Nordisk A/S145
已完成
不适用
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Sweden, as Part of Local Clinical PracticeDiabetes Mellitus, Type 2NCT04601753Novo Nordisk A/S194
已完成
不适用
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Finland, as Part of Local Clinical PracticeDiabetes Mellitus, Type 2NCT05443191Novo Nordisk A/S50
已完成
不适用
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Italy, as Part of Local Clinical PracticeDiabetes Mellitus, Type 2NCT05230615Novo Nordisk A/S458