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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05689372
• Other study ID #: NN9535-4666
• Secondary ID: 1111-1243-9580
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: January 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number (incidence) of adverse events (AEs)	Measured as count of events.	From baseline (week 0) to 26 weeks
Secondary	Number (incidence) of hypoglycaemia level 3 or level 2 according to American Diabetes Association (ADA) guideline 2020	Measured as count of events. Level 2 refers to glucose less than (<) 54 milligrams per deciliter (mg/dL) (3.0 millimoles per liter [mmol/L]). Level 3 refers to a severe event characterized by altered mental and/or physical status requiring assistance for treatment of hypoglycaemia.	From baseline (week 0) to 26 weeks
Secondary	Change in glycated haemoglobin (HbA1c)	Measured in percentage.	From baseline (week 0) to 26 weeks
Secondary	Participants achieving HbA1c target < 7.0 percent (%)	Measured as count of participants.	At 26 weeks
Secondary	Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG)	Measured in milligrams per deciliter (mg/dl).	From baseline (week 0) to 26 weeks
Secondary	Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG)	Measured in mg/dl.	From baseline (week 0) to 26 weeks
Secondary	Change in body weight	Measured in kilogram (kg).	From baseline (week 0) to 26 weeks
Secondary	Dose of Ozempic	Measured in milligrams per day (mg/day).	At 26 weeks