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Completed

NCT Number: NCT06507475

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maharaj Nakorn Chiang Mai Hospital_Nephrology

Chiang Mai, 50200, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Rybelsus

Primary outcomes

  1. Change in Glycated Haemoglobin (HbA1c)

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

    Measured in percentage-point of HbA1c.

Secondary outcomes

  1. Absolute Change in Body Weight

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

    Measured in kilograms.

  2. Relative Change in Body Weight

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

    Measured as percentage change in body weight.

  3. Age of Participants

    Time frame: At baseline (week 0)

    Measured in years.

  4. Percentage of Participants Assessed for Age

    Time frame: At baseline (week 0)

    Measured in percentage of participants.

  5. Number of Participants Assessed for Gender (Male/Female)

    Time frame: At baseline (week 0)

    Measured in participants.

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

    Time frame: At baseline (week 0)

    Measured in percentage of participants.

  7. Diabetes Duration of Participants

    Time frame: At baseline (week 0)

    Measured in years.

  8. Percentage of Participants With Reasons to Initiate Oral Semaglutide Treatment

    Time frame: At baseline (week 0)

    Reasons will be categorized as: Improve glycemic control; Weight reduction; Address cardiovascular risk factors; Other. Measured in percentage of participants.

  9. Body Weight

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

    Measured in kilograms.

  10. 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)

    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.

  11. Fasting Plasma Glucose

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

    Measured in milligrams per deciliter (mg/dL).

  12. Post Prandial Glucose

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

    Measured in milligrams per deciliter (mg/dL).

  13. Diabetes Medications: Type of Drugs Class

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

    Measured in participants.

  14. Diabetes Medications: Number

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

    Measured in number of diabetes medications.

  15. Diabetes Medications: Dosage

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

  16. Waist Circumference

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

    Measured in centimeters.

  17. Body Mass Index

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

    Measured in kilograms per square meter (kg/m^2).

  18. Blood Pressure (systolic/diastolic)

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

    Measured in millimeters of mercury (mmHg).

  19. Estimated Glomerular Filtration Rate (eGFR)

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

    Measured in milliliters per minute (ml/min).

  20. Creatinine

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

    Measured in milligrams per deciliter (mg/dL).

  21. 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)

    Measured in milligrams per deciliter (mg/dL).

  22. 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)

    Measured in percentage of participants.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: REALISED

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2024
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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