NCT02230618已完成不适用
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India
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
- 1,029
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India.
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
- •Informed consent obtained before any study-related activities. (Study-related activities are any procedures that are related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g., HbA1c (Glycated Haemoglobin ), FPG (Fasting Plasma Glucose), PPPG (Postprandial Plasma Glucose), severe hypoglycaemia before the start of Ryzodeg™ therapy) can be used for baseline data
- •Patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with Ryzodeg™ based on the clinical judgment of their treating physician
排除标准
- •Known or suspected allergy to Ryzodeg™ any of the active substances or any of the excipients
- •Previous participation in this study
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- •Patients who are or have previously been on Ryzodeg™ therapy
- •Patients who are participating in other studies or clinical trials
- •Patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
研究组 & 干预措施
Ryzodeg™
干预措施: insulin degludec/insulin aspart (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Weeks 0-52
次要结局
- Adverse Drug Reactions (ADRs)(Weeks 0-52)
- Change in Fasting Plasma Glucose (FPG)(Week 0, week 52)
- Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)(Week 0, week 52)
- Severe or Blood glucose (BG) Confirmed hypoglycaemia(Weeks 0-52)
- Change in HbA1c (glycosylated haemoglobin)(Week 0, week 52)
- Serious Adverse Events (SAEs)(Weeks 0-52)
- Serious Adverse Drug Reactions (SADRs)(Weeks 0-52)
- The reason for initiating or intensifying treatment with Ryzodeg™(Week 0 - week 52)
研究者
研究点 (1)
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