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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1240-4149 | Other Identifier | World Health Organization (WHO) |
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The purpose of the study is to collect information on participant's blood sugar levels, body weight, how satisfied participant is with the treatment, and how participant takes his/her diabetes medicines. Participant will get Rybelsus® as prescribed by 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 |
|---|---|---|---|
| Participants with type 2 diabetes | Participants with type 2 diabetes and naive to injectable glucose-lowering treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Participants 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 participant in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Measured in percentage (%)-points | From baseline (week 0) to End of Study visit (V3) (week 34-44) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured in percentage (%) | From baseline (week 0) to End of Study visit (V3) (week 34-44) |
| Absolute change in body weight | Measured in Kilogram (Kg) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with type 2 diabetes and naive to injectable glucose-lowering treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Master Centre for Spain | Barcelona | 08025 | Spain | |||
| Master Centre for Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40555703 | Derived | Delgado Alvarez E, Morales Portillo C, Abreu Padin C, Aliaga Verdugo A, Piera Carbonell A, Cadenas Gonzalez A, Amor Valero J, Gonzalez Lopez V, Rasmussen CL, Scheuer SH, Bellido Guerrero D. PIONEER REAL Spain: A multicentre, prospective, real-world study of oral semaglutide use in adults with type 2 diabetes. Diabetes Obes Metab. 2025 Sep;27(9):4812-4824. doi: 10.1111/dom.16523. Epub 2025 Jun 24. |
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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% | Measured as Yes or No | End of Study visit (V3) (week 34- 44) |
| HbA1c reduction >=1%-points and body weight reduction of >=5% | Measured as Yes or No | From baseline (week 0) to End of Study visit (V3) (week 34-44) |
| HbA1c reduction >=1%-points and body weight reduction of >=3% | Measured as Yes or No | From baseline (week 0) to End of Study visit (V3) (week 34-44) |
| DTSQc, relative treatment satisfaction | Measured in Total score | End of Study visit (V3) (week 34- 44) |
| DTSQs, change in absolute treatment satisfaction | Measured in Total score | From baseline (week 0) to End of Study visit (V3) (week 34-44) |
| Madrid |
| 28033 |
| Spain |
| D004700 | Endocrine System Diseases |