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Clinical Trial Details

Trial ID: L5358
Source ID: NCT06507475
Associated Drug: Semaglutide
Title: Real World Effectiveness of Oral Semaglutide in Thailand Participants With Type 2 Diabetes
Acronym: REALISED
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide
Outcome Measures: Primary: Change in Glycated Haemoglobin (HbA1c), Measured in percentage-point of HbA1c., Baseline (week 0), end of study (week 26) | Secondary: 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)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 209
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2024-09-30
Completion Date: 2025-01-15
Results First Posted:
Last Update Posted: 2024-09-19
Locations:
URL: https://clinicaltrials.gov/show/NCT06507475