Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1240-3985 | Other Identifier | World Health Organization (WHO) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 participants blood sugar levels. Participants will get Rybelsus® as prescribed to them by their 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...
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Master Centre for Canada | Mississauga | Ontario | L4W 4XI | Canada | ||
| Dr. Nigel N Jagan Medicine Professional Corporation |
| 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. | |
| 38468125 |
Not provided
Not provided
According to the Novo Nordisk disclosure commitment on novonordisktrials.com
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 | 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 (V3) (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 (V3) (week 34-44) |
| Whitby |
| Ontario |
| L1N 2L1 |
| Canada |
| Jain AB, Reichert SM, Amadid H, Braae UC, Bradley RM, Kim JW, Soo V, Yale JF. Use of once-daily oral semaglutide and associated clinical outcomes among adults with type 2 diabetes in routine clinical practice in Canada: A multicentre, prospective real-world study (PIONEER REAL Canada). Diabetes Obes Metab. 2024 May;26(5):1799-1807. doi: 10.1111/dom.15493. Epub 2024 Mar 11. |
| D004700 | Endocrine System Diseases |