Clinical trial

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

Name
NN9924-7577
Description
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.
Trial arms
Trial start
2023-01-25
Estimated PCD
2023-07-09
Trial end
2023-07-09
Status
Completed
Treatment
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.
Arms:
Participants with T2D
Size
288
Primary endpoint
Change in glycated haemoglobin (HbA1c)
From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 288, 'type': 'ACTUAL'}}
Updated at
2024-01-11

1 organization

1 product

2 indications

Organization
Novo Nordisk
Indication
Type 2