NCT05714683尚未招募不适用
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Rybelsus® (Oral Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- Number (Incidence) of adverse events (AEs)
研究概览
简要总结
The aim of this study is to assess the safety and effectiveness of Rybelsus initiated according to label in adults with Type 2 Diabetes Mellitus (T2DM) under routine clinical practice conditions. Participants will get Rybelsus as prescribed by study doctor. The study will last for about 26 weeks.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The decision to initiate treatment with commercially available Rybelsus has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
- •The participant with T2DM is scheduled to start treatment with Rybelsus based on the clinical judgment of their treating physician as specified in the approved label in Korea
- •Informed consent is obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
- •Male/female age greater than or equal to (>=) 19 years at the time of signing informed consent
排除标准
- •Participants who are or have previously been on Rybelsus therapy
- •Known or suspected hypersensitivity to Rybelsus, the active substance or any of the excipients
- •Previous participation in this study. Participation is defined as having given informed consent in this study
- •Female participant who is pregnant, breast-feeding or intends to become pregnant and is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by Korea regulation or practice)
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- •Family or personal history of multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC)
研究组 & 干预措施
Participants with T2DM
All participants will be treated with Rybelsus for 26 weeks according to routine clinical practice at the discretion of the treating physician according to the label approved by Ministry of Food and Drug Safety (MFDS).
干预措施: Semaglutide (Drug)
结局指标
主要结局
Number (Incidence) of adverse events (AEs)
时间窗: From baseline (week 0) to 26 weeks
Measured as count of events.
次要结局
- Participants achieving HbA1c target <7.0%(At 26 weeks)
- Number (Incidence) of hypoglycaemia Level 3 or Level 2(From baseline (week 0) to 26 weeks)
- Change in glycated haemoglobin (HbA1c)(From baseline (week 0) to 26 weeks)
- Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG)(From baseline (week 0) to 26 weeks)
- Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG)(From baseline (week 0) to 26 weeks)
- Change in body weight(From baseline (week 0) to 26 weeks)
- Dose of Rybelsus(At 26 weeks)
研究者
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