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)
- Registration Number
- NCT05468632
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
The purpose of this study is to investigate glycaemic control and other clinical parameters in glucagon like peptide -1 (GLP-1) naive adult participants with type 2 diabetes (T2D) who initiated once weekly (OW) semaglutide in local clinical practice in North Macedonia. The participants were treated according to current clinical practice, applicable local labels, and standard of care as per physicians' discretion. The total duration of the study is planned to be approximately 30 weeks which is the period from OW semaglutide initiation to end of follow up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 314
- Male or female, age above or equal to 18 years at the time of once weekly (OW) semaglutide initiation.
- The decision to initiate treatment with commercially available OW semaglutide has been made by the participant and the treating physician before and independently from the decision to include the participant in this study.
- Adult participants with type 2 diabetes (T2D) initiated with OW semaglutide at least 30 +- 4 weeks prior to data collection.
- Participants should have baseline glycated haemoglobin (HbA1c) measurement and at least one HbA1c measurement after baseline. For baseline HbA1c measurement, the most recent value less than 12 weeks prior to OW semaglutide initiation will be used.
- Previous participation in this study.
- Prior use of GLP-1 within last one year.
- Participants with type-1 diabetes and gestational diabetes.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Glucagon like peptide-1 (GLP-1) naive participants with Type 2 Diabetes (T2D) Semaglutide Glucagon like peptide-1 (GLP-1) naive adult type 2 diabetes (T2D) participants who initiated once weekly (OW) semaglutide were treated according to current clinical practice, applicable local labels, and standard of care as per physicians' discretion.
- Primary Outcome Measures
Name Time Method Change in glycated haemoglobin (HbA1c) From baseline (week 0) to end of follow-up (week 30+- 4 weeks) Measured as percentage (%) point.
- Secondary Outcome Measures
Name Time Method Glycated haemoglobin (HbA1c) less than 7% At end of follow-up (week 30 +- 4 weeks) Measured as Yes/No.
Change in body weight From baseline (week 0) to end of follow-up (week 30+- 4 weeks) Measured as percentage (%).
Change in waist circumference From baseline (week 0) to end of follow-up (week 30+- 4 weeks) Measured in centimeter (cm).
Change in fasting plasma glucose (FPG) From baseline (week 0) to end of follow-up (week 30+- 4 weeks) Measured in millimoles per liter (mmol/l).
Change in Lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides) From baseline (week 0) to end of follow-up (week 30+- 4 weeks) Measured in millimoles per liter (mmol/L).
Change in Blood Pressure (systolic and diastolic) From baseline (week 0) to end of follow-up (week 30+- 4 weeks) Measured in millimiters of mercury (mmHg).
Reduction in glycated haemoglobin (HbA1c) greater than or equal to (>=) 1% From baseline (week 0) to end of follow-up (week 30+- 4 weeks) Measured as Yes/No.
Weight loss >= 5% From baseline (week 0) to end of follow-up (week 30+- 4 weeks) Measured as Yes/No.
HbA1c reduction >= 1% and weight loss of >=3% From baseline (week 0) to end of follow-up (week 30+- 4 weeks) Measured as Yes/No.
Having at least 1 severe hypoglycaemic episode At end of follow-up (week 30 +- 4 weeks) Measured as Yes/No.
Weight loss >= 3% From baseline (week 0) to end of follow-up (week 30+- 4 weeks) Measured as Yes/No.
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇲🇰Veles, North Macedonia