Clinical trial NCT05716724: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with T2D who intend to fast during Ramadan.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in glycated haemoglobin (HbA1c)
timeFrame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
Secondary outcomes:
measure: Relative change in body weight
timeFrame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
measure: Absolute change in body weight
timeFrame: From participant enrolment visit (0 to 8 weeks before Ramadan) to End of follow-up visit (0 to 8 weeks after Ramadan)
measure: Self-reported confirmed hypoglycaemic events
timeFrame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
measure: Self-reported hyperglycaemic episodes requiring hospitalisation
timeFrame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
measure: Number of participants reporting greater than or equal to (>= 1) severe hypoglycaemic events
timeFrame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
measure: Number of self-reported gastrointestinal (GI) side-effects
timeFrame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
measure: Addition of new OAD or increased baseline OAD dose during the study period
timeFrame: At end of follow-up visit (0 to 8 weeks after Ramadan)
measure: Removal of OAD or reduction of baseline OAD dose during the study period
timeFrame: At end of follow-up visit (0 to 8 weeks after Ramadan)
measure: Increase in dose of oral semaglutide
timeFrame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
measure: Decrease in dose of oral semaglutide
timeFrame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
measure: 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
timeFrame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
measure: Intake of oral semaglutide with up to 120 milliliter (mL) of water as reported in patient diary
timeFrame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
measure: Timing of intake of oral semaglutide as reported in patient diary
timeFrame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
Other outcomes:
Locations:
city: Ahmadi
country: Kuwait
facility: KOC Hospital
city: Mangaf
country: Kuwait
facility: New Mowasat Clinics
city: Salmiya,
country: Kuwait
facility: New Mowasat Hospital
city: Salmiya
country: Kuwait
facility: Al Seef Hospital
city: Salmiya
country: Kuwait
facility: Glycemia Clinic
city: Al Khobar
country: Saudi Arabia
facility: Mouwasat Hospital Khobar
city: Ihsaa
country: Saudi Arabia
facility: Almoosa Specialist Hospital
city: Jeddah
country: Saudi Arabia
facility: Saudi German Hospital
city: Riyadh
country: Saudi Arabia
facility: Dr. Sulaiman Al Habib Medical Group- Olaya
city: Riyadh
country: Saudi Arabia
facility: Habib Medical Group
city: Riyadh
country: Saudi Arabia
facility: Al Hammadi
city: Riyadh
country: Saudi Arabia
facility: Dr. Sulaiman Al Habib Medical Group- Swedi
city: Riyadh
country: Saudi Arabia
facility: Dallah Hospital_Riyadh
city: Ajman
country: United Arab Emirates
facility: Thumbay Hospital Ajman
city: Dubai
country: United Arab Emirates
facility: Dubai Hospital
city: Dubai
country: United Arab Emirates
facility: Dubai Diabetes Center
city: Dubai
country: United Arab Emirates
facility: Al Garhoud Private Hospital
city: Dubai
country: United Arab Emirates
facility: Medcare Hospital
city: Dubai
country: United Arab Emirates
facility: NMC Specialty Hospital Dubai
city: Sharjah
country: United Arab Emirates
facility: Oriana Hospital Sharjah
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: