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 A/S288 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

288

Conditions

Diabetes Mellitus, Type 2

Interventions

SemaglutideDRUG

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (20)

KOC Hospital

Al Ahmadi, Kuwait

Al Seef Hospital

As Sālimīyah, Kuwait

Glycemia Clinic

As Sālimīyah, Kuwait

New Mowasat Hospital

As Sālimīyah, Kuwait

New Mowasat Clinics

Mangaf, Kuwait

Almoosa Specialist Hospital

Ihsaa, Saudi Arabia

Saudi German Hospital

Jeddah, Saudi Arabia

Mouwasat Hospital Khobar

Khobar, Saudi Arabia

Dr. Sulaiman Al Habib Medical Group- Olaya

Riyadh, Saudi Arabia

Habib Medical Group

Riyadh, Saudi Arabia

...and 10 more locations

Outcomes

Primary Outcomes

Change in glycated haemoglobin (HbA1c)

Percentage (%) of HbA1c.

Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)

Secondary Outcomes

Relative change in body weight

Measured in percentage.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)