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Enrolling by invitation NCT05689372

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

— Observational Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Semaglutide.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • Number (incidence) of adverse events (AEs) [Time frame: From baseline (week 0) to 26 weeks]
Secondary outcome measures (7)
  • Number (incidence) of hypoglycaemia level 3 or level 2 according to American Diabetes Association (ADA) guideline 2020 [Time frame: From baseline (week 0) to 26 weeks]
  • Change in glycated haemoglobin (HbA1c) [Time frame: From baseline (week 0) to 26 weeks]
  • Participants achieving HbA1c target < 7.0 percent (%) [Time frame: At 26 weeks]
  • Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG) [Time frame: From baseline (week 0) to 26 weeks]
  • Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG) [Time frame: From baseline (week 0) to 26 weeks]
  • Change in body weight [Time frame: From baseline (week 0) to 26 weeks]
  • Dose of Ozempic [Time frame: At 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Wonkwang University Hospital — Jeonlabuk-do

Identifiers

NCT: NCT05689372 · NN9535-4666 · 1111-1243-9580

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗