A multicentre, prospective, non-interventional single-armstudy investigating clinical parameters associated with theinitiation of once-daily oral semaglutide in a real-world adult population with type 2 diabetes in India
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 45
- 主要终点
- To investigate the glycaemic control in adult
研究概览
简要总结
This is a 34 to 44-weeks, multicentre, prospective, open-label, non-interventional, single-arm study, assessing clinical parameters associated with the initiation of once-daily oral semaglutide in adult patients with T2D who have not previously been treated with injectable glucose-lowering medication in routine clinical practice. Data will be obtained through primary data collection. The decision to initiate treatment with oral semaglutide is at the treating physician’s discretion and is clearly separated from the decision to include the patient in the study. Furthermore, no additional diagnostic or monitoring procedures outside of usual clinical practice will be applied to the patients. Planned time period for the study: Sep 2022 to Sep 2023. The study population will consist of male or female patients (18 years or older at the time of signing informed consent) diagnosed with T2D and without any prior or current use of oral semaglutide.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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 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 HbA1c value ≤ 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 < 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.
- •Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of coronavirus disease 2019 (COVID-19) or post-infectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days prior to signing of informed consent.
结局指标
主要结局
To investigate the glycaemic control in adult
时间窗: From baseline End of study (V3)
patients with type 2 diabetes (T2D) who have not previously been treated with injectable glucose-lowering medication and who initiate treatment with oral semaglutide.
时间窗: From baseline End of study (V3)
次要结局
- HbA1c less than 7% at End of Study visit (V3)(End of study visit (V3))
- To investigate mean changes in body(weight in adult patients with T2D who have not previously been treated with injectable glucose-lowering medication and who initiate treatment with oral semaglutide.)