NCT02821052已完成不适用
Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®.
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
- 1,355
- 试验地点
- 1
- 主要终点
- Incidence of AEs (adverse event)
研究概览
简要总结
This trial is conducted in Asia. The aim of this Non-interventional study is to investigate the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
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 Ryzodeg® 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 requiring insulin therapy for whom the physician has decided to start treatment with Ryzodeg®
- •Male or female, no age limitation
排除标准
- •Patients who are or have previously been treated with Ryzodeg®
- •Previous participation in this study. Participation is defined as having given informed consent in this study
- •Patients with a history of hypersensitivity to study product components
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
研究组 & 干预措施
insulin degludec/insulin aspart
干预措施: insulin degludec/insulin aspart (Drug)
结局指标
主要结局
Incidence of AEs (adverse event)
时间窗: Year 0-1
次要结局
- Incidence of SADRs (Serious Adverse Drug Reactions)(Year 0-1)
- Severe hypoglycaemic episodes(Year 0-1)
- Incidence of Serious allergic reactions (systemic or localized, including injection site reactions)(Year 0-1)
- Change in Glycosylated haemoglobin A1c (HbA1c)(Week 0, week 52)
研究者
研究点 (1)
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