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

NCT ID: NCT05689372

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with type 2 diabetes

Participants will be treated with Ozempic (solution for injection 1.34 milligrams per milliliter \[mg/ml\] (Semaglutide subcutaneous \[s.c.\]) according to routine clinical practice conditions for 26 weeks. The physician will determine the dose of Ozempic in accordance with the Korean package insert (K-PI).

Semaglutide

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Ozempic

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Central Contacts

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Novo Nordisk

Role: CONTACT

(+1) 866-867-7178

Other Identifiers

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1111-1243-9580

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-4666

Identifier Type: -

Identifier Source: org_study_id

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