Clinical trial
Regulatory Post Marketing Surveillance (rPMS) Study of Ozempic (Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea
Invitation only · Not applicable · 1 countries · Registry ID NCT05689372
Invitation onlyNot applicableObservational
What this study is about
The aim of this study is to assess the safety and effectiveness of Ozempic initiated according to label in adults with Type 2 Diabetes Mellitus (T2DM) under routine clinical practice conditions. Participants will get Ozempic as prescribed by study doctor. The study will last for about 26 weeks.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age19 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionDiabetes Mellitus, Type 2
Full registry criteria
Inclusion Criteria: * The decision to initiate treatment with commercially available Ozempic has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the participant in this study. * The participant with T2DM is scheduled to start treatment with Ozempic based on the clinical judgment of their treating physician as specified in the approved label in Korea. * Informed consent is obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male/female age greater than or equal to (\>=) 19 years at the time of signing informed consent. Exclusion Criteria: * Participants who are or have previously been on Ozempic therapy. * Known or suspected hypersensitivity to Ozempic, the active substance or any of the excipients. * Previous participation in this study. Participation is defined as having given informed consent in this study. * Female patients who is pregnant, breast-feeding or intends to become pregnant and is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by Korea regulation or practice). * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Treatments and study arms
Semaglutide
Drug
Participants will receive Ozempic (solution for injection 1.34 mg/ml (Semaglutide s.c.) according to routine clinical practice conditions for 26 weeks. The physician will determine the dose of Ozempic in accordance with the K-PI.
Primary outcomes
Number (incidence) of adverse events (AEs)From baseline (week 0) to 26 weeks
Measured as count of events.
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Wonkwang University Hospital🇰🇷 Jeonlabuk-do, South Korea