DelfaGLP-1 Atlas

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O-SEMA-Fast

Completed

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

20

Recruiting sites

—

Enrollment

288

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05716724
Org study IDNN9924-7577
Secondary IDU1111-1280-0404World Health Organization (WHO)

Timeline

Milestones

Study start2023-01-25actual
Study first posted2023-02-08actual
Primary completion2023-07-09actual
Study completion2023-07-09actual
Last update posted2024-01-11actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Participants with T2D who intend to fast during Ramadan.

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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
6
Glycemic / diabetes
3
Weight & body composition
2
Other clinical outcomes
2
Other (unclassified)
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Relative change in body weight

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in body weight

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

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

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)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

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

categorical status, improvement

Secondary/protocol endpoint

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

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

categorical status, improvement

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

Self-reported confirmed hypoglycaemic 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)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Self-reported hyperglycaemic episodes requiring hospitalisation

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

event count, event

Secondary/protocol endpoint

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

Severe hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

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

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

event count, event

Secondary/protocol endpoint

Increase in dose of oral semaglutide

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

categorical status, descriptive

Secondary/protocol endpoint

Intake of oral semaglutide with up to 120 milliliter (mL) of water as reported in patient diary

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

categorical status, descriptive

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint/low confidence

Decrease in dose of oral semaglutide

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

categorical status, descriptive

Secondary/protocol endpoint

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

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

categorical status, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Timing of intake of oral semaglutide as reported in patient diary

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

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.