Real World Effectiveness of Oral Semaglutide in Thailand Participants With Type 2 Diabetes
NCT Number: NCT06507475
Acronym: REALISED
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide
Sponsor: Novo Nordisk A/S
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 209
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2025-01-15

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.

Primary Outcome Measures: Change in Glycated Haemoglobin (HbA1c), Measured in percentage-point of HbA1c., Baseline (week 0), end of study (week 26)
Secondary Outcome Measures: 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)