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

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

This study aims to describe the effectiveness of oral semaglutide on glycemic control and body weight control and describe characteristics of type 2 diabetes (T2D) adult patients who are being treated with oral semaglutide in Thailand. Data of eligible patients with T2D will be collected via electronic medical record or paper-format chart review to assess the effectiveness of oral semaglutide. Total study duration for the individual patient will be six months from baseline. The study duration expands within the window period will be 12 months from baseline which will be the optional visit.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Semaglutide

• Study Type: Observational
• Enrollment (Actual): 209

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital_Nephrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Semaglutide; 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.	Drug: Semaglutide; Participants treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician.; Other Names: Rybelsus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated Haemoglobin (HbA1c)	Measured in percentage-point of HbA1c.	Baseline (week 0), end of study (week 26)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change in Body Weight	Measured in kilograms.	At or within 12 months prior to baseline (week 0), end of study (week 26)
Relative Change in Body Weight	Measured as percentage change in body weight.	At or within 12 months prior to baseline (week 0), end of study (week 26)
Age of Participants	Measured in years.	At baseline (week 0)
Percentage of Participants Assessed for Age	Measured in percentage of participants.	At baseline (week 0)
Number of Participants Assessed for Gender (Male/Female)	Measured in participants.	At baseline (week 0)
Percentage of Participants With Smoking History (Never, Previous, Current)	Measured in percentage of participants.	At baseline (week 0)
Diabetes Duration of Participants	Measured in years.	At baseline (week 0)
Percentage of Participants With Reasons to Initiate Oral Semaglutide Treatment	Reasons will be categorized as: Improve glycemic control; Weight reduction; Address cardiovascular risk factors; Other. Measured in percentage of participants.	At baseline (week 0)
Body Weight	Measured in kilograms.	At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Diabetes Related Co-morbidities (modified Charlson Comorbidity Index [mCCI] Category)	The modified Charlson Comorbidity Index is a commonly used scale for assessing morbidity. It predicts the mortality for a patient who may have a range of comorbidities. It is based on comorbid conditions with varying assigned weights, resulting in a composite score. Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality. A score of zero indicates that no comorbidities were found, the higher the score, the higher the predicted mortality rate is. Measured in score on scale.	At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Fasting Plasma Glucose	Measured in milligrams per deciliter (mg/dL).	At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Post Prandial Glucose	Measured in milligrams per deciliter (mg/dL).	At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Diabetes Medications: Type of Drugs Class	Measured in participants.	At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Diabetes Medications: Number	Measured in number of diabetes medications.	At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Diabetes Medications: Dosage		At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Waist Circumference	Measured in centimeters.	At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Body Mass Index	Measured in kilograms per square meter (kg/m^2).	At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Blood Pressure (systolic/diastolic)	Measured in millimeters of mercury (mmHg).	At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Estimated Glomerular Filtration Rate (eGFR)	Measured in milliliters per minute (ml/min).	At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Creatinine	Measured in milligrams per deciliter (mg/dL).	At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
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	Measured in milligrams per deciliter (mg/dL).	At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Percentage of Participants Achieveing Glycated Haemoglobin (HbA1c) Less Than 7 Percentage (%)	Measured in percentage of participants.	At or within 12 months prior to baseline (week 0), end of study (week 26) and optional visit (week 52-62)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2024
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; semaglutide
• Other Study ID Numbers: NN9924-7830; U1111-1294-2999 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com