A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance (PMS) Study of TresibaÂ® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India

ovo Nordisk India Private Ltd0 个研究点目标入组 1,000 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Informed consent obtained before any study-related activities (Study related activity are any procedure related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g., HbA1c, FPG, severe hypoglycaemia before the start of TresibaÂ® therapy) can be used for baseline data.
•2. Patients with insulin requiring diabetes mellitus and who is scheduled to start treatment with TresibaÂ® based on the clinical judgment of their treating physician.

•1. Known or suspected allergy to TresibaÂ®, the active substance 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 TresibaÂ® 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

发起方

ovo Nordisk India Private Ltd