A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Spain, as Part of Local Clinical Practice

Study Overview
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Brief Summary
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The purpose of the study is to collect information on participant's blood sugar levels, body weight, how satisfied participant is with the treatment, and how participant takes his/her diabetes medicines. Participant will get Rybelsus® as prescribed by 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.

Official Title
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A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Spain

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Semaglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) Diagnosed with type 2 diabetes mellitus 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 Male or female, age above or equal to 18 years at the time of signing informed consent Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice Treatment naive to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than 14 days Exclusion Criteria: Previous participation in this study. Participation is defined as having given informed consent in this study Treatment with any investigational drug within 30 days prior to enrolment into the study Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with type 2 diabetes<br>Participants with type 2 diabetes and naive to injectable glucose-lowering treatment. | Drug: Semaglutide<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | Measured in percentage (%)-points | From baseline (week 0) to End of Study visit (V3) (week 34-44) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) |