Completed

O-SEMA-FastBlood Sugar Control with Oral Semaglutide in Type 2 Diabetes Patients During Ramadan Fasting

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Study Aim

This observational study aims to monitor the change in your blood sugar levels, specifically the glycated haemoglobin (HbA1c), while you are using oral Semaglutide and participating in Ramadan fasting.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2023
See protocol details

Summary

Principal SponsorNovo Nordisk A/S
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 25, 2023

Actual date on which the first participant was enrolled.

This study focuses on individuals with type 2 diabetes who plan to fast during Ramadan and are using oral Semaglutide, a once-daily medication. The main goal is to understand how this medication affects their blood sugar control during this period. The study is important as it aims to provide insights into the safety and effectiveness of oral Semaglutide for diabetic patients who fast, potentially improving their care and management during Ramadan. Participants in this study will take oral Semaglutide as directed by their study doctor. The study lasts about 5 months, during which participants will keep a diary about their medication usage. They will record how and when they take their oral Semaglutide tablets. The primary outcome measured is the change in glycated haemoglobin (HbA1c), which gives an indication of average blood sugar levels over a period of time. This will help evaluate the effectiveness of oral Semaglutide in maintaining blood sugar control during fasting.

Official TitleA 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
NCT05716724
Principal SponsorNovo Nordisk A/S
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

288 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

6 inclusion criteria required to participate
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
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7 exclusion criteria prevent from participating
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 20 locations

Suspended

KOC Hospital

Al Ahmadi, KuwaitOpen KOC Hospital in Google Maps
Suspended

Al Seef Hospital

As Sālimīyah, Kuwait
Suspended

Glycemia Clinic

As Sālimīyah, Kuwait
Suspended

New Mowasat Hospital

As Sālimīyah, Kuwait
Completed20 Study Centers