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

Novo Nordisk

Status: Not yet enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Semaglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT05689372

NN9535-4666

1111-1243-9580 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 1 patient group

Participants with type 2 diabetes

Description:

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).

Treatment:

Drug: Semaglutide