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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1290-8109 | Other Identifier | World Health Organization (WHO) |
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Participant will get oral semaglutde as prescribed by the study doctor. The study will last for about 26 ± 4 weeks (5 to 7 months). Participant will be asked to complete a questionnaire about how they take oral semaglutide tablets during normal scheduled visit with doctor. Participant will also be asked questions about health and their diabetes treatment and lab tests as part of normal doctor's appointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with type 2 diabetes | Participants with Type 2 Diabetes (T2D) will initiate oral semaglutide at the discretion of the treating physician, based on approved oral semaglutide label in Hungary and independent from the decision to include the patient in the study. |
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| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5% | Participants (yes/no). | From Baseline to end of study (week 32) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Measured in percentage (%)- point. | From Baseline to end of study (week 32) |
| Change in fasting plasm glucose (FPG) | Measured in millimoles per liter (mmol/l). |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participant diagnosed with T2D and without any prior or current use of oral semaglutide.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siklósi Kórház, Diabetológia | Recruiting | Siklós | 7801 | Hungary |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| From Baseline to end of study (week 32) |
| Absolute change in body weight (BW) | Measured in kilogram (kg). | From Baseline to end of study (week 32) |
| Relative change in BW | Measured in %. | From Baseline to end of study (week 32) |
| HbA1c less than (<) 7.0% | Participants (yes/no). | At end of study (week 32) |
| HbA1c <6.5% | Participants (yes/no). | At end of study (week 32) |
| Body weight reduction ≥5% | Participants (yes/no). | At end of study (week 32) |
| HbA1c reduction ≥1%-point and BW reduction ≥5% | Participants (yes/no). | From Baseline to end of study (week 32) |
| HbA1c reduction ≥1%-point and BW reduction ≥3% | Participants (yes/no). | From Baseline to end of study (week 32) |
| Change in waist circumference | Measured in centimeter (cm). | From Baseline to end of study (week 32) |
| Change in blood pressure (BP) (systolic and diastolic) | Measured in millimeter of mercury (mmHg). | From Baseline to end of study (week 32) |
| Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG]) | Measured in mmol/L. | From Baseline to end of study (week 32) |
| Change in high sensitive C-reactive protein (hsCRP) | Measured in milligram per liter (mg/l). | From Baseline to end of study (week 32) |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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