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Clinical Trial Details

Trial ID: L4208
Source ID: NCT05716724
Associated Drug: Semaglutide
Title: 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
Acronym: O-SEMA-Fast
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide
Outcome Measures: Primary: 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: 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)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 288
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2023-01-25
Completion Date: 2023-07-09
Results First Posted:
Last Update Posted: 2024-01-11
Locations: KOC Hospital, Ahmadi, 060008, Kuwait|New Mowasat Clinics, Mangaf, 053700, Kuwait|New Mowasat Hospital, Salmiya,, 22077, Kuwait|Al Seef Hospital, Salmiya, 020000, Kuwait|Glycemia Clinic, Salmiya, 020000, Kuwait|Mouwasat Hospital Khobar, Al Khobar, 34234, Saudi Arabia|Almoosa Specialist Hospital, Ihsaa, 22141, Saudi Arabia|Saudi German Hospital, Jeddah, 23521, 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, United Arab Emirates
URL: https://clinicaltrials.gov/show/NCT05716724