NCT05689372尚未招募不适用
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Ozempic Solution for Injection 1.34mg/ml (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
- 试验地点
- 1
- 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 Ozempic initiated according to label in adults with Type 2 Diabetes Mellitus (T2DM) under routine clinical practice conditions. Participants will get Ozempic 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
- All
- 接受健康志愿者
- 否
入选标准
- •The decision to initiate treatment with commercially available Ozempic has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the participant in this study.
- •The participant with T2DM is scheduled to start treatment with Ozempic 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 Ozempic therapy.
- •Known or suspected hypersensitivity to Ozempic, 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 patients 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.
研究组 & 干预措施
Participants with type 2 diabetes
Participants will be treated with Ozempic (solution for injection 1.34 milligrams per milliliter [mg/ml] (Semaglutide subcutaneous [s.c.]) according to routine clinical practice conditions for 26 weeks. The physician will determine the dose of Ozempic in accordance with the Korean package insert (K-PI).
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
- Dose of Ozempic(At 26 weeks)
- Change in glycated haemoglobin (HbA1c)(From baseline (week 0) to 26 weeks)
- Participants achieving HbA1c target < 7.0 percent (%)(At 26 weeks)
- Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG)(From baseline (week 0) to 26 weeks)
- Number (incidence) of hypoglycaemia level 3 or level 2 according to American Diabetes Association (ADA) guideline 2020(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)
研究者
研究点 (1)
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