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

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Semaglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT05716724

NN9924-7577

U1111-1280-0404 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 288 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

288 participants in 1 patient group

Participants with T2D

Description:

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.

Treatment:

Drug: Semaglutide