CTRI/2015/12/006442已完成Unknown
A multi-centre, prospective, open-label, single-arm, non-interventional, post marketing surveillance (PMS) study of RyzodegTM (insulin degludec/insulin aspart) to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India
Novo Nordisk India Private Ltd39 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2015年11月24日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 39
- 主要终点
- To assess the safety of long-term treatment with insulin degludec/ insulin aspart (Ryzodegâ„¢) in insulin requiring patients with diabetes mellitus, initiating treatment with Ryzodegâ„¢ under routine clinical practice in India.
研究概览
简要总结
A multi-centre, prospective, open-label, single-arm, non-interventional, post marketing surveillance (PMS) study of RyzodegTM (insulin degludec/insulin aspart) 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
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
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, FPG, PPPG, severe hypoglycaemia before the start of Ryzodegâ„¢ therapy) can be used for baseline data
- •Patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with Ryzodegâ„¢ based on the clinical judgment of their treating physician.
- •More than 18 years old, male / female patients".
排除标准
- •Known or suspected allergy to Ryzodegâ„¢ 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 Ryzodegâ„¢ 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".
结局指标
主要结局
To assess the safety of long-term treatment with insulin degludec/ insulin aspart (Ryzodegâ„¢) in insulin requiring patients with diabetes mellitus, initiating treatment with Ryzodegâ„¢ under routine clinical practice in India.
时间窗: 1 year
次要结局
- To assess efficacy and additional safety of long term (1 year) treatment with Ryzodegâ„¢
研究者
研究点 (39)
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