O-SEMA-Fast: A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes Who Plan to Fast During Ramadan in the United Arab Emirates, Saudi Arabia, and Kuwait

Study Overview
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Brief Summary
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The purpose of the study is to look at the change in blood sugar levels in people with type 2 diabetes who are using oral semaglutide and planning to fast during Ramadan. Participants will take oral semaglutide as prescribed by the study doctor. The study will last for about 5 months (20 weeks). Participants will be asked to complete a patient diary about how and when they take the oral semaglutide tablets. Participants will complete this diary during the study period as instructed by study doctor.

Official Title
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A Prospective, Non-interventional Study, Investigating Glycaemic Control and Treatment Patterns Associated With the Use of Once-daily Oral Semaglutide in Type 2 Diabetes Patients Who Intend to Fast During Ramadan in the United Arab Emirates, Saudi Arabia, and Kuwait

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) The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician 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 Patients diagnosed with T2D who intend to fast during Ramadan Patient should be on oral semaglutide (at least 4 weeks on maintenance dose) with or without other OADs Available HbA1c value ≤ 30 days prior to the patient enrolment visit (V1) or HbA1c measurement taken in relation with the patient enrolment visit (V1) if in line with local clinical practice Exclusion Criteria: Previous participation in this study. Participation is defined as having given informed consent in this study Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the patient enrolment visit (V1) and throughout the duration of the study Patients with type-1 diabetes and gestational diabetes Patients who are pregnant or are planning to become pregnant during the conduct of the study Patients who are breastfeeding Patients on Insulin therapy within 2 weeks prior to enrolment 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 T2D<br>The study is non-interventional as there are no interventions involved and the decision to initiate oral semaglutide treatment is at the discretion of the treating physician and is clearly independent from the decision to include the participant in the study. Participants will be treated with oral semaglutide (at least 4 weeks on maintenance dose) once daily with or without other oral antidiabetics (OADs) as per local label at the discretion of the treating physician. | Drug: Semaglutide<br>* Participants will receive oral semaglutide with or without other OADs as per local label at the discretion of the treating physician and is clearly independent from the decision to include the participant in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycated haemoglobin (HbA1c) | Percentage (%) of HbA1c. | From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change in body weight | Measured in percentage. | From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan) | 
| Absolute change in body weight | Measured in kilogram (kg). | From participant enrolment visit (0 to 8 weeks before Ramadan) to End of follow-up visit (0 to 8 weeks after Ramadan) | 
| Self-reported confirmed hypoglycaemic events | Measured in count of events. | From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan) | 
| Self-reported hyperglycaemic episodes requiring hospitalisation | Measured in count of episodes. | From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan) | 
| Number of participants reporting greater than or equal to (>= 1) severe hypoglycaemic events | Measured in count of participants. | From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan) | 
| Number of self-reported gastrointestinal (GI) side-effects | Measured in count of events. | From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan) | 
| Addition of new OAD or increased baseline OAD dose during the study period | Measured in count of participants (yes or no). | At end of follow-up visit (0 to 8 weeks after Ramadan) | 
| Removal of OAD or reduction of baseline OAD dose during the study period | Measured in count of participants (yes or no). | At end of follow-up visit (0 to 8 weeks after Ramadan) | 
| Increase in dose of oral semaglutide | Measured in count of participants (yes or no). | From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan) | 
| Decrease in dose of oral semaglutide | Measured in count of participants (yes or no). | From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan) | 
| Waiting time of at least 30 min after intake of oral semaglutide and before eating or drinking or taking any other oral medicinal product as per local label and as reported in patient diary | Measured in count of participants (yes or no). | From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan) | 
| Intake of oral semaglutide with up to 120 milliliter (mL) of water as reported in patient diary | Measured in count of participants (yes or no). | From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan) | 
| Timing of intake of oral semaglutide as reported in patient diary | Time before iftar (before iftar is before breaking the fast)/time before suhour (before suhour is before the last meal)/others. | From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan) |