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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1240-4396 | 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 participant's blood sugar levels. Participants will get Rybelsus® as prescribed by the study doctor. The study will last for about 8-10 months. Participant will be asked to complete a questionnaire about how the participant will take Rybelsus® tablets. Participant will complete this questionnaire during the normally scheduled visit with the study doctor. Participant will be asked to complete some questionnaires about diabetes treatment. Participant will complete these questionnaires during normally scheduled visits with the study doctor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Participants with T2D will be assessed for clinical parameters associated with the once-daily use of oral semaglutide who have not previously been treated with injectable glucose-lowering medication in routine clinical practice. |
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| 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 T2D will be assessed for clinical parameters associated with the once-daily use of oral semaglutide who have not previously been treated with injectable glucose-lowering medication in routine clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Investigacion Clinica Endocrinologica de Jalisco | Guadalajara | Jalisco | 44670 | Mexico | ||
| CICEJ Centro de Investigacion Clinica Endocrinologica de Jalisco SC |
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) |
| Guadalajara |
| Jalisco |
| 44670 |
| Mexico |
| D004700 | Endocrine System Diseases |