NCT01984372已完成不适用
A Multi-centre, Open Label, Observational, Non-interventional, Post Marketing Surveillance to Evaluate Safety and Effectiveness During Long-term Treatment With Tresiba® (Insulin Degludec) in Patients With Diabetes Mellitus Requiring Insulin Therapy Under Normal Clinical Practice Conditions
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
- 6,163
- 试验地点
- 1
- 主要终点
- Incidence of AEs (Adverse Events) by preferred term
研究概览
简要总结
This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
A total of 4000 patients will be enrolled to investigate long term (3 years of treatment) safety of Tresiba® and additional 2000 patients will be enrolled to assess the safety in an early stage of the PMS more precisely. At the time of enrolment the patients will be randomly allocated to either 3 years or 6 months observation group.
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
- •Patients with diabetes mellitus requiring insulin therapy for whom the treating physician has decided to start Tresiba® treatment
排除标准
- •Patients who are or have previously been on Tresiba® therapy
- •Patients who have previously been participating in this PMS
研究组 & 干预措施
Tresiba® users
干预措施: insulin degludec (Drug)
结局指标
主要结局
Incidence of AEs (Adverse Events) by preferred term
时间窗: During 3 years of treatment
次要结局
- Incidence of severe hypoglycaemia(During 3 years of treatment)
- Incidence of AEs (Adverse Events) by preferred term(During 6 months of treatment)
- Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term(During 3 years of treatment)
- Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term(During 3 years of treatment)
研究者
研究点 (1)
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