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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1270-0826 | Other Identifier | World Health Organization (WHO) |
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The purpose of the study is to look at the change in blood sugar levels in participants with type 2 diabetes who start using oral semaglutide. Participants will get oral semaglutide as prescribed to them by the study doctor. The study will last for about 8-11 months (34-44 weeks). Participants will be asked to complete a questionnaire about how they take oral semaglutide tablets. Participants will complete this questionnaire during the normal scheduled visit with the doctor and will be asked questions about their health and their diabetes treatment and lab tests as part of their normal doctor's appointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with type 2 diabetes | Adult participants with type 2 diabetes and naive to injectable glucose-lowering treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral 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 Glycated haemoglobin A1c (HbA1c) | Measured as 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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Adult 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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41229720 | Derived | Sanyal D, Saboo B, Phatak SR, Kumar PKM, Basu D, Verma N, Nair A, Bhattacharjee K, Aneja P, Makkar BMM, Negalur V, Mithal A, Unnikrishnan AG. Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes: Findings from PIONEER REAL India. Indian J Endocrinol Metab. 2025 Sep-Oct;29(5):523-530. doi: 10.4103/ijem.ijem_179_25. Epub 2025 Oct 25. |
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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) |
| Glycated haemoglobin A1c (HbA1c) less than (<) 7% | Measured as Yes or No. | At 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% | Measured as Yes or No. | 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% | Measured as Yes or No. | From baseline (week 0) to End of Study visit (V3) (week 34-44) |
| D004700 | Endocrine System Diseases |