Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGSemaglutide
Participants treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | Baseline (week 0), end of study (week 26) | Measured in percentage-point of HbA1c. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Assessed for Gender (Male/Female) | At baseline (week 0) | Measured in participants. |
| Diabetes Medications: Dosage | At or within 12 months prior to baseline (week 0) to optional visit (week 52-62) | — |
| Absolute Change in Body Weight | At or within 12 months prior to baseline (week 0), end of study (week 26) | Measured in kilograms. |
| Relative Change in Body Weight | At or within 12 months prior to baseline (week 0), end of study (week 26) | Measured as percentage change in body weight. |
| Age of Participants | At baseline (week 0) | Measured in years. |
| Percentage of Participants With Smoking History (Never, Previous, Current) | At baseline (week 0) | Measured in percentage of participants. |
| Diabetes Duration of Participants | At baseline (week 0) | Measured in years. |
| Percentage of Participants With Reasons to Initiate Oral Semaglutide Treatment | At baseline (week 0) | Reasons will be categorized as: Improve glycemic control; Weight reduction; Address cardiovascular risk factors; Other. Measured in percentage of participants. |
| Body Weight | At or within 12 months prior to baseline (week 0) to optional visit (week 52-62) | Measured in kilograms. |
| Diabetes Related Co-morbidities (modified Charlson Comorbidity Index [mCCI] Category) | 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. |
| Percentage of Participants Assessed for Age | At baseline (week 0) | Measured in percentage of participants. |
| Post Prandial Glucose | At or within 12 months prior to baseline (week 0) to optional visit (week 52-62) | Measured in milligrams per deciliter (mg/dL). |
| Diabetes Medications: Type of Drugs Class | At or within 12 months prior to baseline (week 0) to optional visit (week 52-62) | Measured in participants. |
| Diabetes Medications: Number | At or within 12 months prior to baseline (week 0) to optional visit (week 52-62) | Measured in number of diabetes medications. |
| Waist Circumference | At or within 12 months prior to baseline (week 0) to optional visit (week 52-62) | Measured in centimeters. |
| Body Mass Index | 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). |
| Blood Pressure (systolic/diastolic) | At or within 12 months prior to baseline (week 0) to optional visit (week 52-62) | Measured in millimeters of mercury (mmHg). |
| Estimated Glomerular Filtration Rate (eGFR) | At or within 12 months prior to baseline (week 0) to optional visit (week 52-62) | Measured in milliliters per minute (ml/min). |
| Creatinine | At or within 12 months prior to baseline (week 0) to optional visit (week 52-62) | Measured in milligrams per deciliter (mg/dL). |
| 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 | At or within 12 months prior to baseline (week 0) to optional visit (week 52-62) | Measured in milligrams per deciliter (mg/dL). |
| Percentage of Participants Achieveing Glycated Haemoglobin (HbA1c) Less Than 7 Percentage (%) | 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. |
| Fasting Plasma Glucose | At or within 12 months prior to baseline (week 0) to optional visit (week 52-62) | Measured in milligrams per deciliter (mg/dL). |
Countries
Thailand
Outcome results
None listed