Clinical trial

A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Ozempic Solution for Injection 1.34mg/ml (Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

Name

NN9535-4666

Description

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.

Trial arms

Trial start

2024-06-30

Estimated PCD

2026-11-30

Trial end

2026-11-30

Status

Not yet recruiting

Treatment

Semaglutide

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.

Arms:

Participants with type 2 diabetes

Other names:

Ozempic

Size

600

Primary endpoint

Number (incidence) of adverse events (AEs)

From baseline (week 0) to 26 weeks

Eligibility 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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}

Updated at

2024-02-01

1 organization

1 product

2 indications

Product

Indication

Indication

Organization