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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Semaglutide

• Study Type: Observational
• Enrollment (Actual): 288

Contacts and Locations

Study Locations

• Kuwait
  • Ahmadi, Kuwait, 060008
    • KOC Hospital
  • Mangaf, Kuwait, 053700
    • New Mowasat Clinics
  • Salmiya, Kuwait, 020000
    • Al Seef Hospital
  • Salmiya, Kuwait, 020000
    • Glycemia Clinic
  • Salmiya,, Kuwait, 22077
    • New Mowasat Hospital
• Saudi Arabia
  • Al Khobar, Saudi Arabia, 34234
    • Mouwasat Hospital Khobar
  • Ihsaa, Saudi Arabia, 22141
    • Almoosa Specialist Hospital
  • Jeddah, Saudi Arabia, 23521
    • Saudi German Hospital
  • Riyadh, Saudi Arabia, 11643
    • Dr. Sulaiman Al Habib Medical Group- Olaya
  • Riyadh, Saudi Arabia, 12343
    • Habib Medical Group
  • Riyadh, Saudi Arabia, 12474
    • Al Hammadi
  • Riyadh, Saudi Arabia, 12987
    • Dr. Sulaiman Al Habib Medical Group- Swedi
  • Riyadh, Saudi Arabia, 14963
    • Dallah Hospital_Riyadh
• United Arab Emirates
  • Ajman, United Arab Emirates, 4184
    • Thumbay Hospital Ajman
  • Dubai, United Arab Emirates
    • Al Garhoud Private Hospital
  • Dubai, United Arab Emirates, 500001
    • Dubai Hospital
  • Dubai, United Arab Emirates, 9115
    • Dubai Diabetes Center
  • Dubai, United Arab Emirates
    • Medcare Hospital
  • Dubai, United Arab Emirates
    • NMC Specialty Hospital Dubai
  • Sharjah, United Arab Emirates
    • Oriana Hospital Sharjah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with T2D who intend to fast during Ramadan.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Actual): July 9, 2023
• Study Completion (Actual): July 9, 2023

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: January 29, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9924-7577; U1111-1280-0404 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No