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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1247-5339 | Other Identifier | World Health Organization (WHO) |
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The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels, and to get side-effects information. Participants will get Rybelsus® as prescribed to them by the study doctor.
The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with type 2 diabetes | Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral semaglutide | Drug | Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | percent-points | From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) |
| Number of adverse event (AEs) | Count | From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | percent | From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) |
| Absolute change in body weight | Kilogram (Kg) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 1452 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Master Centre for Japan | Tokyo | 1000005 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38711208 | Result | Suzuki R, Amadid H, Major-Pedersen A, Yabe D. PIONEER REAL Japan: Baseline characteristics of a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in clinical practice in Japan. J Diabetes Investig. 2024 Aug;15(8):1047-1056. doi: 10.1111/jdi.14219. Epub 2024 May 6. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) |
| HbA1c less than 7 percent (Yes/No) | Percentage of patients achieving or not achieving the target value | End of Study visit (Visit 3) (week 34-44) |
| HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 5 percent (Yes/No) | Percentage of patients achieving or not achieving the target value | From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) |
| HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 3 percent (Yes/No) | Percentage of patients achieving or not achieving the target value | From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) |
| Number of adverse reactions (ARs) | Count | From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) |
| Number of serious adverse events (SAEs) | Count | From baseline (week 0) to End of Study visit (Visit3) (week 34-44) |
| Number of serious adverse reactions (SARs) | Count | From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) |
| D004700 | Endocrine System Diseases |