MIRAGE

Completed

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)

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

314

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05468632

Org study IDNN9535-4976

Secondary IDU1111-1273-4429World Health Organization (WHO)

Timeline

Milestones

Study start2022-07-05actual

Study first posted2022-07-21actual

Primary completion2022-07-31actual

Study completion2022-07-31actual

Last update posted2023-02-14actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Sampling methodNon probability sample

Study population text

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.

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.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

5 endpoints

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Weight loss >= 5%

Time frame:From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight loss >= 3%

Time frame:From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

threshold achievement, improvement

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Glycated haemoglobin (HbA1c) less than 7%

Time frame:At end of follow-up (week 30 +- 4 weeks)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Reduction in glycated haemoglobin (HbA1c) greater than or equal to (>=) 1%

Time frame:From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change in Lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides)

Time frame:From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

change from baseline, improvement

Secondary/protocol endpoint

Change in Blood Pressure (systolic and diastolic)

Time frame:From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Having at least 1 severe hypoglycaemic episode

Time frame:At end of follow-up (week 30 +- 4 weeks)

Severe hypoglycemia

categorical status, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

HbA1c reduction >= 1% and weight loss of >=3%

Time frame:From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Once-weekly semaglutide use in glucagon-like peptide-1 receptor agonist naïve patients with type 2 diabetes in North Macedonia: Real-world data from the MIRAGE study.
Diabetes research and clinical practice2023 Dec (month)PMID37972857doi:10.1016/j.diabres.2023.111018via pubmed acronym asset candidate

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.