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 Mexico
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 2
- 主要终点
- Change in 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 participant's blood sugar levels. Participants will get Rybelsus® as prescribed by the study doctor. The study will last for about 8-10 months. Participant will be asked to complete a questionnaire about how the participant will take Rybelsus® tablets. Participant will complete this questionnaire during the normally scheduled visit with the study doctor. Participant will be asked to complete some questionnaires about diabetes treatment. Participant will complete these questionnaires during 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 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 naive 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
Semaglutide
Participants with T2D will be assessed for clinical parameters associated with the once-daily use of oral semaglutide who have not previously been treated with injectable glucose-lowering medication in routine clinical practice.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Measured in percentage (%)-points
次要结局
- Absolute change in body weight(From baseline (week 0) to End of Study visit (V3) (week 34-44))
- DTSQc, relative treatment satisfaction(End of Study visit (V3) (week 34- 44))
- HbA1c < 7%(End of Study visit (V3) (week 34- 44))
- 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 reduction >=1%-points and body weight reduction of >=5%(From baseline (week 0) to End of Study visit (V3) (week 34-44))
- HbA1c reduction >=1%-points and body weight reduction of >=3%(From baseline (week 0) to End of Study visit (V3) (week 34-44))