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Clinical Trial Details

Trial ID: L5975
Source ID: NCT05468632
Associated Drug: Semaglutide
Title: A Study in North Macedonia Investigating Retrospective Data of Glucagon-like Peptide-1 (GLP-1) Participants With Type 2 Diabetes (T2D) in Real World Environment (RWE) Setting (MIRAGE)
Acronym: MIRAGE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide
Outcome Measures: Primary: Change in glycated haemoglobin (HbA1c), Measured as percentage (%) point., From baseline (week 0) to end of follow-up (week 30+- 4 weeks) | Secondary: Change in body weight, Measured in kilograms (kg)., From baseline (week 0) to end of follow-up (week 30+- 4 weeks)|Change in body weight, Measured as percentage (%)., From baseline (week 0) to end of follow-up (week 30+- 4 weeks)|Change in waist circumference, Measured in centimeter (cm)., From baseline (week 0) to end of follow-up (week 30+- 4 weeks)|Change in fasting plasma glucose (FPG), Measured in millimoles per liter (mmol/l)., From baseline (week 0) to end of follow-up (week 30+- 4 weeks)|Change in Lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides), Measured in millimoles per liter (mmol/L)., From baseline (week 0) to end of follow-up (week 30+- 4 weeks)|Change in Blood Pressure (systolic and diastolic), Measured in millimiters of mercury (mmHg)., From baseline (week 0) to end of follow-up (week 30+- 4 weeks)|Glycated haemoglobin (HbA1c) less than 7%, Measured as Yes/No., At end of follow-up (week 30 +- 4 weeks)|Reduction in glycated haemoglobin (HbA1c) greater than or equal to (>=) 1%, Measured as Yes/No., From baseline (week 0) to end of follow-up (week 30+- 4 weeks)|Weight loss >= 5%, Measured as Yes/No., From baseline (week 0) to end of follow-up (week 30+- 4 weeks)|Weight loss >= 3%, Measured as Yes/No., From baseline (week 0) to end of follow-up (week 30+- 4 weeks)|HbA1c reduction >= 1% and weight loss of >=3%, Measured as Yes/No., From baseline (week 0) to end of follow-up (week 30+- 4 weeks)|Having at least 1 severe hypoglycaemic episode, Measured as Yes/No., At end of follow-up (week 30 +- 4 weeks)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 314
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2022-07-05
Completion Date: 2022-07-31
Results First Posted:
Last Update Posted: 2023-02-14
Locations: Novo Nordisk Investigational Site, Bitola, 7000, North Macedonia|Novo Nordisk Investigational Site, Debar, 1250, North Macedonia|Novo Nordisk Investigational Site, General Hospital Kavadarci, 1430, North Macedonia|Novo Nordisk Investigational Site, Gostivar, 1230, North Macedonia|Novo Nordisk Investigational Site, Kicevo, 6250, North Macedonia|Novo Nordisk Investigational Site, Kochani, 2300, North Macedonia|Novo Nordisk Investigational Site, Kumanovo, 1300, North Macedonia|Novo Nordisk Investigational Site, Ohrid, 6000, North Macedonia|Novo Nordisk Investigational Site, Prilep, 7500, North Macedonia|Novo Nordisk Investigational Site, Shtip, 2000, North Macedonia|Novo Nordisk Investigational Site, Skopje, 1 000, North Macedonia|Novo Nordisk Investigational Site, Skopje, 1000, North Macedonia|Novo Nordisk Investigational Site, Skopje, SK 1000, North Macedonia|Novo Nordisk Investigational Site, Struga, 6330, North Macedonia|Novo Nordisk Investigational Site, Stumica, 2400, North Macedonia|Novo Nordisk Investigational Site, Tetovo, 1220, North Macedonia|Novo Nordisk Investigational Site, Veles, 1400, North Macedonia
URL: https://clinicaltrials.gov/show/NCT05468632