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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1240-4321 | 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.
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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 HbA1c (Glycated haemoglobin) | Measured as percent-points | From baseline (week 0) to End of Study visit (V3) (week 34-44) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured as Percent | 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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Adult patients with type 2 diabetes and naïve 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 Israel | Kfar Saba | 44425 | Israel |
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 below 7% | Percentage of participants achieving or not achieving the target value | End of Study visit (V3) (week 34-44) |
| HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 5% | Percentage of participants achieving or not achieving the reduction | From baseline (week 0) to End of Study visit (V3) (week 34-44) |
| HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 3% | Percentage of patients achieving or not achieving the reduction | From baseline (week 0) to End of Study visit (V3) (week 34-44) |
| DTSQc (Diabetes Treatment Satisfaction Questionnaire, change), relative treatment satisfaction | The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a Total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc Total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction. | End of Study visit (V3) (week 34-44) |
| DTSQs (Diabetes Treatment Satisfaction Questionnaire, status), change in absolute treatment satisfaction | The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items. | From baseline (week 0) to End of Study visit (V3) (week 34-44) |
| D004700 | Endocrine System Diseases |