CTRI/2015/12/006442已完成4 期
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 - Ryzodeg PMS study
ovo Nordisk India Private Ltd0 个研究点目标入组 976 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 976
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. 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 Ryzodeg• therapy) can be used for baseline data
- •2. Patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with Ryzodeg• based on the clinical judgment of their treating physician.
- •3. More than 18 years old, male / female patients
排除标准
- •1. Known or suspected allergy to Ryzodeg• any of the active substances or any of the excipients
- •2. Previous participation in this study
- •3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •4. Patients who are or have previously been on Ryzodeg• therapy.
- •5. Patients who are participating in other studies or clinical trials
- •6. Patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
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