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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1240-3705 | 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 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 treat the participant with a given product is independent of the decision to include him/her in the 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) |
| 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 who are 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 United Kingdom | Gatwick | West Sussex | RH6 0PA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39316289 | Result | Saravanan P, Bell H, Braae UC, Collins E, Deinega A, Dhatariya K, Machell A, Trent A, Strzelecka A. PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes. Adv Ther. 2024 Nov;41(11):4266-4281. doi: 10.1007/s12325-024-02973-z. Epub 2024 Sep 24. | |
| 39535683 | Derived |
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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 reduction | End of Study visit (Visit 3) (week 34-44) |
| HbA1c reduction greater than or equal to 1 percent-points and body weight reduction greater than or equal to 5 percent (Yes/No) | percentage of patients achieving or not achieving the reduction | 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 reduction | From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) |
| Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction | The change version (DTSQc) has the same 8 items as the status version but is reworded to direct the patients to rate their change in treatment satisfaction compared to before being treated with oral semaglutide. Each question is scored on a scale of -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. | End of Study visit (Visit 3) (week 34-44) |
| Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction | The status version (DTSQs) provides a measure of how satisfied patients are with their current diabetes treatment. It consists of 8 questions, which are to be answered on a Likert scale from 0 to 6 (0 = very dissatisfied to 6 = very satisfied). Six questions are summed to produce a total Treatment Satisfaction score. The remaining two questions are concerning perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia, respectively. | From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) |
| 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. |
| D004700 | Endocrine System Diseases |