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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1240-4249 | 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. 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.
Participants will be asked to complete some questionnaires about their diabetes treatment. Participants will complete these during their normally scheduled visits 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 (V3) (week 34-44) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Percent | From baseline (week 0) to End of Study visit (V3) (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 Netherlands | Alphen aan den Rijn | 2408 AV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39535683 | Derived | Rudofsky G, Amadid H, Braae UC, Catrina SB, Kick A, Mandavya K, Roslind K, Saravanan P, van Houtum W, Jain AB. Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies. Diabetes Ther. 2025 Jan;16(1):73-87. doi: 10.1007/s13300-024-01668-6. Epub 2024 Nov 13. | |
| 38861137 |
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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 (V3) (week 34-44) |
| HbA1c <7% (Yes/No) | Percentage of patients achieving or not achieving the target value | End of Study visit (V3) (week 34-44) |
| HbA1c reduction >=1%-points and body weight reduction of >=5% (Yes/No) | Percentage of patients achieving or not achieving the reduction | From baseline (week 0) to End of Study visit (V3) (week 34-44) |
| HbA1c reduction >=1%-points and body weight reduction of >=3% (Yes/No) | Percentage of patients achieving or not achieving the reduction | From baseline (week 0) to End of Study visit (V3) (week 34-44) |
| Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction | Total score | End of Study visit (V3) (week 34-44) |
| Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction | Total score | From baseline (week 0) to End of Study visit (V3) (week 34-44) |
| van Houtum W, Schrombges P, Amadid H, van Bon AC, Braae UC, Hoogstraten C, Herrings H. Real-World Use of Oral Semaglutide in Adults with Type 2 Diabetes in the PIONEER REAL Netherlands Multicentre, Prospective, Observational Study. Diabetes Ther. 2024 Aug;15(8):1749-1768. doi: 10.1007/s13300-024-01588-5. Epub 2024 Jun 11. |
| D004700 | Endocrine System Diseases |