Diabetes Mellitus, Type 2REALISEDNCT06507475
Real World Effectiveness of Oral Semaglutide in Thailand Participants With Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 209 participants
- Where
- 1 siteThailand
- Study dates
- 7 Sep 2024to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Maharaj Nakorn Chiang Mai Hospital_Nephrology
Chiang Mai, 50200
About this study
Official 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
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
- Being tested
- Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Rybelsus
Participants treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Haemoglobin (HbA1c)
Measured in percentage-point of HbA1c.
Measured: Baseline (week 0), end of study (week 26)
Secondary outcomes (22)
Absolute Change in Body Weight
Measured in kilograms.
Measured: 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.
Measured: At or within 12 months prior to baseline (week 0), end of study (week 26)
Age of Participants
Measured in years.
Measured: At baseline (week 0)
Percentage of Participants Assessed for Age
Measured in percentage of participants.
Measured: At baseline (week 0)
Number of Participants Assessed for Gender (Male/Female)
Measured in participants.
Measured: At baseline (week 0)
Percentage of Participants With Smoking History (Never, Previous, Current)
Measured in percentage of participants.
Measured: At baseline (week 0)
Diabetes Duration of Participants
Measured in years.
Measured: 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.
Measured: At baseline (week 0)
Body Weight
Measured in kilograms.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Diabetes Medications: Dosage
Measured: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Waist Circumference
Measured in centimeters.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Creatinine
Measured in milligrams per deciliter (mg/dL).
Measured: 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).
Measured: 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.
Measured: At or within 12 months prior to baseline (week 0), end of study (week 26) and optional visit (week 52-62)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start7 Sep 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507475
- Sponsor's protocol ID
- NN9924-7830
- Other IDs
- U1111-1294-2999
- Acronym
- REALISED
- Status last verified
- Dec 2025
- First submitted
- 12 Jul 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06507475
- Acronym / sponsor ID
- REALISED / NN9924-7830
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | – | Drug: SemaglutideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: RybelsusParticipants treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. | Drug | Semaglutide |
Primary outcome
Change in Glycated Haemoglobin (HbA1c)
Time frame: Baseline (week 0), end of study (week 26)
Measured in percentage-point of HbA1c.
22 secondary outcomes
Absolute Change in Body Weight
Time frame: At or within 12 months prior to baseline (week 0), end of study (week 26)
Relative Change in Body Weight
Time frame: At or within 12 months prior to baseline (week 0), end of study (week 26)
Age of Participants
Time frame: At baseline (week 0)
Percentage of Participants Assessed for Age
Time frame: At baseline (week 0)
Number of Participants Assessed for Gender (Male/Female)
Time frame: At baseline (week 0)
Percentage of Participants With Smoking History (Never, Previous, Current)
Time frame: At baseline (week 0)
Diabetes Duration of Participants
Time frame: At baseline (week 0)
Percentage of Participants With Reasons to Initiate Oral Semaglutide Treatment
Time frame: At baseline (week 0)
Body Weight
Time frame: 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)
Time frame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Fasting Plasma Glucose
Time frame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Post Prandial Glucose
Time frame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Diabetes Medications: Type of Drugs Class
Time frame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Diabetes Medications: Number
Time frame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Diabetes Medications: Dosage
Time frame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Waist Circumference
Time frame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Body Mass Index
Time frame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Blood Pressure (systolic/diastolic)
Time frame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Estimated Glomerular Filtration Rate (eGFR)
Time frame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
Creatinine
Time frame: 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
Time frame: 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 (%)
Time frame: At or within 12 months prior to baseline (week 0), end of study (week 26) and optional visit (week 52-62)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Haemoglobin (HbA1c) (time frame: Baseline (week 0), end of study (week 26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.