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Clinical Trial Details

Trial ID: L2103
Source ID: NCT06269120
Associated Drug: Oral Semaglutide
Title: SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Oral Semaglutide
Outcome Measures: Primary: Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5%, Participants (yes/no)., From Baseline to end of study (week 32) | Secondary: Change in HbA1c, Measured in percentage (%)- point., From Baseline to end of study (week 32)|Change in fasting plasm glucose (FPG), Measured in millimoles per liter (mmol/l)., From Baseline to end of study (week 32)|Absolute change in body weight (BW), Measured in kilogram (kg)., From Baseline to end of study (week 32)|Relative change in BW, Measured in %., From Baseline to end of study (week 32)|HbA1c less than (<) 7.0%, Participants (yes/no)., At end of study (week 32)|HbA1c <6.5%, Participants (yes/no)., At end of study (week 32)|Body weight reduction ≥5%, Participants (yes/no)., At end of study (week 32)|HbA1c reduction ≥1%-point and BW reduction ≥5%, Participants (yes/no)., From Baseline to end of study (week 32)|HbA1c reduction ≥1%-point and BW reduction ≥3%, Participants (yes/no)., From Baseline to end of study (week 32)|Change in waist circumference, Measured in centimeter (cm)., From Baseline to end of study (week 32)|Change in blood pressure (BP) (systolic and diastolic), Measured in millimeter of mercury (mmHg)., From Baseline to end of study (week 32)|Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG]), Measured in mmol/L., From Baseline to end of study (week 32)|Change in high sensitive C-reactive protein (hsCRP), Measured in milligram per liter (mg/l)., From Baseline to end of study (week 32)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 470
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2024-09-30
Completion Date: 2025-09-30
Results First Posted:
Last Update Posted: 2025-03-11
Locations: Siklósi Kórház, Diabetológia, Siklós, 7801, Hungary
URL: https://clinicaltrials.gov/show/NCT06269120