NCT04469855已完成不适用
Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®. A Multi-centre, Open-label, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Effectiveness of Ozempic® (Semaglutide) in Japanese Patients With Type 2 Diabetes Mellitus Under Normal Clinical Practice Condition
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,217
- 试验地点
- 828
- 主要终点
- Number of adverse events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety of long-term treatment with Ozempic® in patients with type 2 diabetes mellitus. People will get Ozempic® as prescribed by their doctor. People will be in this study about 3 years. People above the age of 18 will be asked to fill in the quality of life (QOL) questionnaire (the QOL questionnaire is for the assessment of the influence of diabetes treatment on people's life). There is a possibility that people's blood sample would be provided to Novo Nordisk from their doctors in case of severe allergic reaction that might be caused by Ozempic®.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 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).
- •The decision to initiate treatment with commercially available Ozempic® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
- •Patients with Diabetes Mellitus, Type 2 (T2DM) who the physician has decided to start treatment with Ozempic®.
- •Male or female, no age limitation.
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •Patients who fall under contraindications to the label.
- •Patients who are or have previously been treated with Ozempic®.
- •Female who is pregnant, breast-feeding or intends to become pregnant.
研究组 & 干预措施
Ozempic®
Japanese people with type 2 diabetes being treated in normal clinical practice conditions
干预措施: semaglutide (Drug)
结局指标
主要结局
Number of adverse events (AEs)
时间窗: From baseline (day 0) to end of study (month 36)
Count
次要结局
- Number of serious adverse reactions (SARs)(From baseline (day 0) to end of study (month 36))
- Number of adverse reactions (ARs)(From baseline (day 0) to end of study (month 36))
- Number of serious adverse events (SAEs)(From baseline (day 0) to end of study (month 36))
- Change in glycosylated haemoglobin A1c (HbA1c)(From baseline (day 0) to end of study (month 36))
- Change in fasting plasma glucose (FPG)(From baseline (day 0) to end of study (month 36))
- Change in body weight(From baseline (day 0) to end of study (month 36))
- Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - total score(From baseline (day 0) to visit 5 (month 12))
- Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - burden of social activities and daily activities(From baseline (day 0) to visit 5 (month 12))
- Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - anxiety and dissatisfaction with treatment(From baseline (day 0) to visit 5 (month 12))
- Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - hypoglycaemia(From baseline (day 0) to visit 5 (month 12))
- Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - satisfaction with treatment(From baseline (day 0) to visit 5 (month 12))
研究者
研究点 (828)
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