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Diabetes Mellitus, Type 2O-SEMA-FastNCT05716724

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

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 20 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Semaglutide
Type of treatment
Pill or oral medicine
How many people
288 participants
Where
20 sitesin 3 countries
Study dates
25 Jan 2023to 9 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with T2D who intend to fast during Ramadan.

Who may be able to join

  • 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
  • Patient should be on oral semaglutide (at least 4 weeks on maintenance dose) with or without other OADs
  • 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

Who cannot join

  • 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
  • Patients who are breastfeeding
  • Patients on Insulin therapy within 2 weeks prior to enrolment
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Trial locations and contacts

20 sites in 3 countries.

20 sites in 3 countries

Saudi Arabia8 sites

  • Almoosa Specialist Hospital

    Ihsaa, 22141

  • Saudi German Hospital

    Jeddah, 23521

  • Mouwasat Hospital Khobar

    Khobar, 34234

  • Dr. Sulaiman Al Habib Medical Group- Olaya

    Riyadh, 11643

  • Habib Medical Group

    Riyadh, 12343

  • Al Hammadi

    Riyadh, 12474

  • Dr. Sulaiman Al Habib Medical Group- Swedi

    Riyadh, 12987

  • Dallah Hospital_Riyadh

    Riyadh, 14963

Other trials in Saudi Arabia

United Arab Emirates7 sites

  • Thumbay Hospital Ajman

    Ajman, 4184

  • Dubai Hospital

    Dubai, 500001

  • Dubai Diabetes Center

    Dubai, 9115

  • Al Garhoud Private Hospital

    Dubai

  • Medcare Hospital

    Dubai

  • NMC Specialty Hospital Dubai

    Dubai

  • Oriana Hospital Sharjah

    Sharjah city

Other trials in United Arab Emirates

Kuwait5 sites

  • KOC Hospital

    Al Ahmadi, 060008

  • Al Seef Hospital

    As Sālimīyah, 020000

  • Glycemia Clinic

    As Sālimīyah, 020000

  • New Mowasat Hospital

    As Sālimīyah, 22077

  • New Mowasat Clinics

    Mangaf, 053700

Other trials in Kuwait

About this study

Official title: 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

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.

Being tested
Semaglutide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05716724
Study groupRoleWhat they receive
Participants with T2DThe 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.
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glycated haemoglobin (HbA1c)

    Percentage (%) of HbA1c.

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

Secondary outcomes (13)

  1. Relative change in body weight

    Measured in percentage.

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

  2. Absolute change in body weight

    Measured in kilogram (kg).

    Measured: From participant enrolment visit (0 to 8 weeks before Ramadan) to End of follow-up visit (0 to 8 weeks after Ramadan)

  3. Self-reported confirmed hypoglycaemic events

    Measured in count of events.

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

  4. Self-reported hyperglycaemic episodes requiring hospitalisation

    Measured in count of episodes.

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

  5. Number of participants reporting greater than or equal to (>= 1) severe hypoglycaemic events

    Measured in count of participants.

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

  6. Number of self-reported gastrointestinal (GI) side-effects

    Measured in count of events.

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

  7. Addition of new OAD or increased baseline OAD dose during the study period

    Measured in count of participants (yes or no).

    Measured: At end of follow-up visit (0 to 8 weeks after Ramadan)

  8. Removal of OAD or reduction of baseline OAD dose during the study period

    Measured in count of participants (yes or no).

    Measured: At end of follow-up visit (0 to 8 weeks after Ramadan)

  9. Increase in dose of oral semaglutide

    Measured in count of participants (yes or no).

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

  10. Decrease in dose of oral semaglutide

    Measured in count of participants (yes or no).

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

  11. 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).

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

  12. 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).

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

  13. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start25 Jan 2023
  3. Primary completion9 Jul 2023
  4. Study completion9 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05716724
Sponsor's protocol ID
NN9924-7577
Other IDs
U1111-1280-0404
Acronym
O-SEMA-Fast
Status last verified
Jan 2024
First submitted
29 Jan 2023
Last updated
11 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Hassanein M, Alawadi F, AlKadhim I, Aly H, Bajawi D, Cinar T, Dhanwal D, Jabbar A, Khader S, Khudadah K, Muzaffar T, Ngome M, Nafach J, Shaghouli A; O-SEMA-FAST Investigators. O-SEMA-FAST: A Prospective, Non-interventional Study Investigating Oral Semaglutide Use in Adults with Type 2 Diabetes Mellitus During Ramadan. Diabetes Ther. 2025 Apr;16(4):663-684. doi: 10.1007/s13300-025-01702-1. Epub 2025 Feb 28.

    PubMed 40016571

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 20 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Saudi Arabia, United Arab Emirates, Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in glycated haemoglobin (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05716724, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.

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