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

Diabetes Mellitus, Type 2 Clinical Trial

— O-SEMA-Fast  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05716724
• Other study ID #: NN9924-7577
• Secondary ID: U1111-1280-0404
• Status: Completed
• Start date: January 25, 2023
• Est. completion date: July 9, 2023

Study information

• Verified date: January 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: July 9, 2023
• Est. primary completion date: July 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)

2. 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

3. Male or female, age above or equal to 18 years at the time of signing informed consent

4. Patients diagnosed with T2D who intend to fast during Ramadan

5. Patient should be on oral semaglutide (at least 4 weeks on maintenance dose) with or without other OADs

6. 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:

1. Previous participation in this study. Participation is defined as having given informed consent in this study

2. 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

3. Patients with type-1 diabetes and gestational diabetes

4. Patients who are pregnant or are planning to become pregnant during the conduct of the study

5. Patients who are breastfeeding

6. Patients on Insulin therapy within 2 weeks prior to enrolment

7. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Semaglutide
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.

Locations

Country	Name	City	State
Kuwait	KOC Hospital	Ahmadi
Kuwait	New Mowasat Clinics	Mangaf
Kuwait	Al Seef Hospital	Salmiya
Kuwait	Glycemia Clinic	Salmiya
Kuwait	New Mowasat Hospital	Salmiya,
Saudi Arabia	Mouwasat Hospital Khobar	Al Khobar
Saudi Arabia	Almoosa Specialist Hospital	Ihsaa
Saudi Arabia	Saudi German Hospital	Jeddah
Saudi Arabia	Al Hammadi	Riyadh
Saudi Arabia	Dallah Hospital_Riyadh	Riyadh
Saudi Arabia	Dr. Sulaiman Al Habib Medical Group- Olaya	Riyadh
Saudi Arabia	Dr. Sulaiman Al Habib Medical Group- Swedi	Riyadh
Saudi Arabia	Habib Medical Group	Riyadh
United Arab Emirates	Thumbay Hospital Ajman	Ajman
United Arab Emirates	Al Garhoud Private Hospital	Dubai
United Arab Emirates	Dubai Diabetes Center	Dubai
United Arab Emirates	Dubai Hospital	Dubai
United Arab Emirates	Medcare Hospital	Dubai
United Arab Emirates	NMC Specialty Hospital Dubai	Dubai
United Arab Emirates	Oriana Hospital Sharjah	Sharjah

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Kuwait,  Saudi Arabia,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)