Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGSemaglutide
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.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number (incidence) of adverse events (AEs) | From baseline (week 0) to 26 weeks | Measured as count of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| 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). |
| Dose of Ozempic | At 26 weeks | Measured in milligrams per day (mg/day). |
Countries
South Korea
Contacts
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed