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
O-SEMA-Fast
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
2 other identifiers
observational
288
3 countries
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Shorter than P25 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 25, 2023
CompletedFirst Submitted
Initial submission to the registry
January 29, 2023
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2023
CompletedJanuary 11, 2024
January 1, 2024
6 months
January 29, 2023
January 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Relative change in body weight
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
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
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
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
From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
- +8 more secondary outcomes
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Participants with T2D who intend to fast during Ramadan.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (20)
KOC Hospital
Al Ahmadi, 060008, Kuwait
Al Seef Hospital
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
Related Publications (1)
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.
PMID: 40016571DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2023
First Posted
February 8, 2023
Study Start
January 25, 2023
Primary Completion
July 9, 2023
Study Completion
July 9, 2023
Last Updated
January 11, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com