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) (MIRAGE)

A Multicentre, Single-arm, Retrospective Study Investigating Glycaemic Control in GLP-1 Naive Participants With Type 2 Diabetes Who Initiated Once-weekly Semaglutide (OZEMPIC) in a Real World Setting in North Macedonia

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Semaglutide

• Study Type: Observational
• Enrollment (Actual): 314

Contacts and Locations

Study Locations

• North Macedonia
  • Bitola, North Macedonia, 7000
    • Novo Nordisk Investigational Site
  • Debar, North Macedonia, 1250
    • Novo Nordisk Investigational Site
  • General Hospital Kavadarci, North Macedonia, 1430
    • Novo Nordisk Investigational Site
  • Gostivar, North Macedonia, 1230
    • Novo Nordisk Investigational Site
  • Kicevo, North Macedonia, 6250
    • Novo Nordisk Investigational Site
  • Kochani, North Macedonia, 2300
    • Novo Nordisk Investigational Site
  • Kumanovo, North Macedonia, 1300
    • Novo Nordisk Investigational Site
  • Ohrid, North Macedonia, 6000
    • Novo Nordisk Investigational Site
  • Prilep, North Macedonia, 7500
    • Novo Nordisk Investigational Site
  • Shtip, North Macedonia, 2000
    • Novo Nordisk Investigational Site
  • Skopje, North Macedonia, 1000
    • Novo Nordisk Investigational Site
  • Skopje, North Macedonia, 1 000
    • Novo Nordisk Investigational Site
  • Skopje, North Macedonia, SK 1000
    • Novo Nordisk Investigational Site
  • Struga, North Macedonia, 6330
    • Novo Nordisk Investigational Site
  • Stumica, North Macedonia, 2400
    • Novo Nordisk Investigational Site
  • Tetovo, North Macedonia, 1220
    • Novo Nordisk Investigational Site
  • Veles, North Macedonia, 1400
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Previous participation in this study.
• Prior use of GLP-1 within last one year.
• Participants with type-1 diabetes and gestational diabetes.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Glucagon like peptide-1 (GLP-1) naive participants with Type 2 Diabetes (T2D); 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.	Drug: Semaglutide; Participants who initiated once weekly (OW) semaglutide in routine clinical practice in were enrolled in the study. The participants were treated according to current clinical practice, applicable local labels, and standard of care as per physicians' discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glycated haemoglobin (HbA1c)	Measured as percentage (%) point.	From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 5, 2022
• Primary Completion (ACTUAL): July 31, 2022
• Study Completion (ACTUAL): July 31, 2022

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (ACTUAL): July 21, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9535-4976; U1111-1273-4429 (OTHER: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.