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
- Registration Number
- NCT05689372
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with type 2 diabetes Semaglutide 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).
- Primary Outcome Measures
Name Time Method Number (incidence) of adverse events (AEs) From baseline (week 0) to 26 weeks Measured as count of events.
- Secondary Outcome Measures
Name Time Method Dose of Ozempic At 26 weeks Measured in milligrams per day (mg/day).
Change in glycated haemoglobin (HbA1c) From baseline (week 0) to 26 weeks Measured in percentage.
Participants achieving HbA1c target < 7.0 percent (%) At 26 weeks Measured as count of participants.
Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG) From baseline (week 0) to 26 weeks Measured in milligrams per deciliter (mg/dl).
Number (incidence) of hypoglycaemia level 3 or level 2 according to American Diabetes Association (ADA) guideline 2020 From baseline (week 0) to 26 weeks 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.
Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG) From baseline (week 0) to 26 weeks Measured in mg/dl.
Change in body weight From baseline (week 0) to 26 weeks Measured in kilogram (kg).