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

NCT05689372 | Enrolling By Invitation

• 2 other identifiers: NN9535-46661111-1243-9580
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Number (incidence) of adverse events (AEs)

  Measured as count of events.

  From baseline (week 0) to 26 weeks

Secondary Outcomes (7)

• Number (incidence) of hypoglycaemia level 3 or level 2 according to American Diabetes Association (ADA) guideline 2020

  From baseline (week 0) to 26 weeks

• Change in glycated haemoglobin (HbA1c)

  From baseline (week 0) to 26 weeks

• Participants achieving HbA1c target < 7.0 percent (%)

  At 26 weeks

• Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG)

  From baseline (week 0) to 26 weeks

• Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG)

  From baseline (week 0) to 26 weeks

Study Arms (1)

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).

Drug: Semaglutide

Interventions

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.

Also known as: Ozempic

Participants with type 2 diabetes

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with T2DM will be treated with Ozempic according to routine clinical practice conditions for 26 weeks. The physician will determine the dose of Ozempic in accordance with the K-PI.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Wonkwang University Hospital

Jeonlabuk-do, 54538, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 19, 2023
• Study Start: February 2, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)