A multicentre, prospective, non-interventional single-armstudy investigating clinical parameters associated with theinitiation of once-daily oral semaglutide in a real-world adult population with type 2 diabetes in India

ovo Nordisk AS0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•1. Signed consent obtained before any study-related activities (study-related activities are any
•procedure related to recording of data according to the protocol).
•2. Diagnosed with T2D.
•3. The decision to initiate treatment with commercially available oral semaglutide 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.
•4. Male or female, age above or equal to 18 years at the time of signing informed consent.
•5. Available HbA1c value = 90 days prior to the ‘Informed Consent and Treatment Initiation visit’
•(V1) or HbA1c measurement taken in relation with the ‘Informed Consent and Treatment
•Initiation visit’ (V1) if in line with local clinical practice.
•6. Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin
•treatment for acute illness for a total of < 14 days.

•1. Previous participation in this study. Participation is defined as having given informed consent in this study.
•2. Any prior or current use of oral semaglutide.
•3. Hypersensitivity to oral semaglutide or to any of the excipients.
•4. Treatment with any investigational drug within 30 days prior to signing of informed consent.
•5. Participation in any clinical trial of an approved or non-approved investigational medicinal
•product within 30 days prior to signing of informed consent.
•6. Mental incapacity, unwillingness or language barriers precluding adequate understanding or
•cooperation.
•Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of coronavirus disease 2019 (COVID-19) or post-infectious conditions is allowed if the last dose of the investigational
•medicinal product has been received more than 30 days prior to signing of informed consent

发起方

ovo Nordisk AS