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

NCT06507475 | Completed

• 2 other identifiers: NN9924-7830U1111-1294-2999
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Haemoglobin (HbA1c)

  Measured in percentage-point of HbA1c.

  Baseline (week 0), end of study (week 26)

Secondary Outcomes (22)

• Absolute Change in Body Weight

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

• Relative Change in Body Weight

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

• Age of Participants

  At baseline (week 0)

• Percentage of Participants Assessed for Age

  At baseline (week 0)

• Number of Participants Assessed for Gender (Male/Female)

  At baseline (week 0)

Study Arms (1)

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

Interventions

Semaglutide DRUG

Participants treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician.

Also known as: Rybelsus

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Maharaj Nakorn Chiang Mai Hospital_Nephrology

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: September 7, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)