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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1243-9500 | Other Identifier | World Health Organization (WHO) |
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The aim of this study is to assess the safety and effectiveness of Rybelsus initiated according to label in adults with Type 2 Diabetes Mellitus (T2DM) under routine clinical practice conditions. Participants will get Rybelsus as prescribed by study doctor. The study will last for about 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with T2DM | All participants will be treated with Rybelsus for 26 weeks according to routine clinical practice at the discretion of the treating physician according to the label approved by Ministry of Food and Drug Safety (MFDS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | All participants will be treated with oral semaglutide for 26 weeks according to routine clinical practice at the discretion of the treating physician according to the label approved by MFDS. The prescription of semaglutide will be separated from the decision to include the participant in the study. |
| 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 | Hypoglycaemia Level 3 or Level 2 according to American Diabetes Association (ADA) guideline 2020 refers to: 1) Level 2: Glucose less than (<) 54 milligrams per deciliter (mg/dL) (3.0 millimoles per liter [mmol/L]); 2) Level 3: A severe event characterized by altered mental and/or physical status requiring assistance for treatment of hypoglycaemia. Measured as count of events. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with T2DM, who initiate treatment with Rybelsus under routine clinical practice in Korea.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
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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% | Measured as count of participants (Yes/No). | At 26 weeks |
| Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG) | Measured in 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 Rybelsus | 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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