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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1280-0404 | 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with T2D | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with T2D who intend to fast during Ramadan.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KOC Hospital | Al Ahmadi | 060008 | Kuwait | |||
| Al Seef Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40016571 | Derived | Hassanein M, Alawadi F, AlKadhim I, Aly H, Bajawi D, Cinar T, Dhanwal D, Jabbar A, Khader S, Khudadah K, Muzaffar T, Ngome M, Nafach J, Shaghouli A; O-SEMA-FAST Investigators. O-SEMA-FAST: A Prospective, Non-interventional Study Investigating Oral Semaglutide Use in Adults with Type 2 Diabetes Mellitus During Ramadan. Diabetes Ther. 2025 Apr;16(4):663-684. doi: 10.1007/s13300-025-01702-1. Epub 2025 Feb 28. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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) |
| As Sālimīyah |
| 020000 |
| Kuwait |
| Glycemia Clinic | As Sālimīyah | 020000 | Kuwait |
| New Mowasat Hospital | As Sālimīyah | 22077 | Kuwait |
| New Mowasat Clinics | Mangaf | 053700 | Kuwait |
| Almoosa Specialist Hospital | Ihsaa | 22141 | Saudi Arabia |
| Saudi German Hospital | Jeddah | 23521 | Saudi Arabia |
| Mouwasat Hospital Khobar | Khobar | 34234 | Saudi Arabia |
| Dr. Sulaiman Al Habib Medical Group- Olaya | Riyadh | 11643 | Saudi Arabia |
| Habib Medical Group | Riyadh | 12343 | Saudi Arabia |
| Al Hammadi | Riyadh | 12474 | Saudi Arabia |
| Dr. Sulaiman Al Habib Medical Group- Swedi | Riyadh | 12987 | Saudi Arabia |
| Dallah Hospital_Riyadh | Riyadh | 14963 | Saudi Arabia |
| Thumbay Hospital Ajman | Ajman | 4184 | United Arab Emirates |
| Dubai Hospital | Dubai | 500001 | United Arab Emirates |
| Dubai Diabetes Center | Dubai | 9115 | United Arab Emirates |
| Al Garhoud Private Hospital | Dubai | United Arab Emirates |
| Medcare Hospital | Dubai | United Arab Emirates |
| NMC Specialty Hospital Dubai | Dubai | United Arab Emirates |
| Oriana Hospital Sharjah | Sharjah city | United Arab Emirates |
| 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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