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| ID | Type | Description | Link |
|---|---|---|---|
| 1111-1243-9580 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with type 2 diabetes | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number (incidence) of adverse events (AEs) | Measured as count of events. | From baseline (week 0) to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with T2DM will be treated with Ozempic according to routine clinical practice conditions for 26 weeks. The physician will determine the dose of Ozempic in accordance with the K-PI.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonkwang University Hospital | Jeonlabuk-do | 54538 | South Korea |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| From baseline (week 0) to 26 weeks |
| Change in glycated haemoglobin (HbA1c) | Measured in percentage. | From baseline (week 0) to 26 weeks |
| Participants achieving HbA1c target < 7.0 percent (%) | Measured as count of participants. | At 26 weeks |
| Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG) | Measured in milligrams per deciliter (mg/dl). | From baseline (week 0) to 26 weeks |
| Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG) | Measured in mg/dl. | From baseline (week 0) to 26 weeks |
| Change in body weight | Measured in kilogram (kg). | From baseline (week 0) to 26 weeks |
| Dose of Ozempic | Measured in milligrams per day (mg/day). | At 26 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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