NCT05502562进行中（未招募）不适用
A Multicentre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Initiation of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in India
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 388
- 主要终点
- Change in Glycated haemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of the study is to look at the change in blood sugar levels in participants with type 2 diabetes who start using oral semaglutide. Participants will get oral semaglutide as prescribed to them by the study doctor. The study will last for about 8-11 months (34-44 weeks). Participants will be asked to complete a questionnaire about how they take oral semaglutide tablets. Participants will complete this questionnaire during the normal scheduled visit with the doctor and will be asked questions about their health and their 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).
- •Diagnosed with type 2 diabetes (T2D).
- •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 A1c (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 or equal to (<=) 14 days.
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Any prior or current use of oral semaglutide.
- •Hypersensitivity to oral semaglutide or to any of the excipients.
- •Treatment with any investigational drug within 30 days prior to signing of informed consent.
- •Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to signing of informed consent.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
研究组 & 干预措施
Participants with type 2 diabetes
Adult participants with type 2 diabetes and naive to injectable glucose-lowering treatment.
干预措施: Oral semaglutide (Drug)
结局指标
主要结局
Change in Glycated haemoglobin A1c (HbA1c)
时间窗: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Measured as percentage (%)-points.
次要结局
- Relative change in body weight(From baseline (week 0) to End of Study visit (V3) (week 34-44))
- Absolute change in body weight(From baseline (week 0) to End of Study visit (V3) (week 34-44))
- Glycated haemoglobin A1c (HbA1c) less than (<) 7%(At End of Study visit (V3) (week 34-44))
- HbA1c reduction greater than or equal to (>=) 1%-points and body weight reduction of greater than or equal to (>=) 5%(From baseline (week 0) to End of Study visit (V3) (week 34-44))
- HbA1c reduction greater than or equal to (>=) 1%-points and body weight reduction of greater than or equal to (>=) 3%(From baseline (week 0) to End of Study visit (V3) (week 34-44))
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