REALISED

Completed

Real World Effectiveness of Oral Semaglutide in Thailand Participants With Type 2 Diabetes

Real World Effectiveness of Oral Semaglutide in Thailand Patients With Type 2 Diabetes: an Observational, Multicentre, Retrospective Cohort Study REAL-world Effectiveness of Oral Semaglutide In a Cohort of Thai patientS With Type 2 Diabetes treatED With Oral Antidiabetic Medications (REALISED) Study

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

209

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≤12%

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 IDNCT06507475

Org study IDNN9924-7830

Secondary IDU1111-1294-2999World Health Organization (WHO)

Timeline

Milestones

Study first posted2024-07-18actual

Study start2024-09-07actual

Primary completion2024-12-20actual

Study completion2024-12-20actual

Last update posted2025-12-30actual

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 diagnosed with type 2 diabetes (T2D) who had initiated once-daily oral semaglutide during the target selection period of April 2022 to December 2023 and have not previously been treated with injectable glucose-lowering medication in routine clinical practice.

Inclusion criteria

•Adult Thai male or female patients aged greater than or equal to (≥) 18 years.

•Diagnosed with T2D either through International Classification of Diseases (ICD) code or by physician's description such as documentation in the medical record, and who have not previously been treated with injectable glucose-lowering medication.

•At least one recent or closest Glycated Haemoglobin (HbA1c) test value available and documented less than or equal to 12 weeks prior to the initiation of oral semaglutide.

•Had initiated oral semaglutide for diabetes during the target selection period of April 2022 to December 2023. All required data for collection should already be accessible prior to the initiation of data collection.

•Treated with oral semaglutide for at least 6 months without interruption or discontinuation.

Exclusion criteria

•Previous participation in this study. Participation is defined as having given informed consent in this study (if applicable).

•Participants with any diagnosis of type 1 diabetes (T1D).

•Medical records documenting prior or ongoing treatment with injectable glucose-lowering treatment.

Endpoints (23)

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

Glycemic / diabetes

Other (unclassified)

Weight & body composition

Renal / kidney

Cardiometabolic biomarkers

Other clinical outcomes

Weight & body composition

5 endpoints

Secondary/protocol endpoint

Absolute Change in Body Weight

Time frame:At or within 12 months prior to baseline (week 0), end of study (week 26)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Relative Change in Body Weight

Time frame:At or within 12 months prior to baseline (week 0), end of study (week 26)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Body Weight

Time frame:At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Waist Circumference

Time frame:At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Body Mass Index

Time frame:At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)

BMI, change

change from baseline, improvement

Glycemic / diabetes

7 endpoints

Primary/protocol endpoint

Change in Glycated Haemoglobin (HbA1c)

Time frame:Baseline (week 0), end of study (week 26)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting Plasma Glucose

Time frame:At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Post Prandial Glucose

Time frame:At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)

Postprandial glucose

descriptive

Secondary/protocol endpoint

Diabetes Medications: Type of Drugs Class

Time frame:At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)

descriptive

Secondary/protocol endpoint

Diabetes Medications: Number

Time frame:At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)

descriptive

Secondary/protocol endpoint

Diabetes Medications: Dosage

Time frame:At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)

descriptive

Secondary/protocol endpoint

Percentage of Participants Achieveing Glycated Haemoglobin (HbA1c) Less Than 7 Percentage (%)

Time frame:At or within 12 months prior to baseline (week 0), end of study (week 26) and optional visit (week 52-62)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Renal / kidney

2 endpoints

Secondary/protocol endpoint

Estimated Glomerular Filtration Rate (eGFR)

Time frame:At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Creatinine

Time frame:At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)

descriptive

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Blood Pressure (systolic/diastolic)

Time frame:At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)

descriptive, improvement

Secondary/protocol endpoint

Lipid profile: Low-density Lipoprotein Cholesterol (LDL), Non-high-density Lipoprotein Cholesterol (non-HDL), High-density Lipoprotein Cholesterol (HDL), Very Low Density Lipoprotein (VLDL), Total Cholesterol and Triglycerides

Time frame:At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)

descriptive, improvement

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Diabetes Related Co-morbidities (modified Charlson Comorbidity Index [mCCI] Category)

Time frame:At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)

descriptive

Other (unclassified)

6 endpoints

Secondary/protocol endpoint

Age of Participants

Time frame:At baseline (week 0)

descriptive

Secondary/protocol endpoint

Percentage of Participants Assessed for Age

Time frame:At baseline (week 0)

descriptive

Secondary/protocol endpoint

Number of Participants Assessed for Gender (Male/Female)

Time frame:At baseline (week 0)

descriptive

Secondary/protocol endpoint

Percentage of Participants With Smoking History (Never, Previous, Current)

Time frame:At baseline (week 0)

descriptive

Secondary/protocol endpoint/low confidence

Diabetes Duration of Participants

Time frame:At baseline (week 0)

descriptive

Secondary/protocol endpoint/low confidence

Percentage of Participants With Reasons to Initiate Oral Semaglutide Treatment

Time frame:At baseline (week 0)

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

Use of Oral Semaglutide and Associated Clinical Outcomes in Thai Patients With Type 2 Diabetes: Real-World Evidence From the REALISED Study.
Diabetes, obesity & metabolism2026 Jun (month)PMID41877352doi:10.1111/dom.70701via pubmed acronym asset candidate

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.