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Not Yet Recruiting 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

Conditions: Diabetes Mellitus, Type 2

Sex: All
Ages: 18 Years – N/A
Enrollment: 288
Sponsor: Novo Nordisk A/S

Location: Kuwait

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: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 studyMale or female, age above or equal to 18 years at the time of signing informed consentPatients diagnosed with T2D who intend to fast during RamadanPatient should be on oral semaglutide (at least 4 weeks on maintenance dose) with or without other OADsAvailable 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 practiceExclusion Criteria:Previous participation in this study. Participation is defined as having given informed consent in this studyParticipation 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 studyPatients with type-1 diabetes and gestational diabetesPatients who are pregnant or are planning to become pregnant during the conduct of the studyPatients who are breastfeedingPatients on Insulin therapy within 2 weeks prior to enrolmentMental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05716724). StuddyBuddy aggregates publicly available trial information.