CTRI/2019/07/020371招募中未知
ARISE: A multi-centre prospective non-interventional study investigating the clinical effectiveness of Ryzodeg®(Insulin Degludec/Insulin Aspart) in patients with type 2 diabetes mellitus in a real-world setting - ARISE
ovo Nordisk India Private Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol.
- •2.The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before, and independently from, the decision to include the patient in this study.
- •3.Male or female, age above or equal to 18 years at the time of signing informed consent.
- •4.Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 26 weeks prior to signing informed consent.
- •5.Available and documented Glycosylated haemoglobin (HbA1c) value less than or equal to 12 weeks prior to signing informed consent.
排除标准
- •1.Hypersensitivity to the active substance or to any of the excipients as specified in the Ryzodeg® local label.
- •2.Previous participation in this study. Participation is defined as signed informed consent.
- •3.Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •4.Previous treatment with Ryzodeg®.
研究者
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