NCT05468632|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)

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

2 other identifiers

NN9535-4976U1111-1273-4429

Study Type

observational

Target

314

Locations

1 country

Sites

Timeline

RegisteredJul 2022

StartedJul 2022

CompletionJul 2022

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

314

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach

1 country

17 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

26 days study duration

Study Start

First participant enrolled

July 5, 2022

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2022

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed

10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed

Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

26 days

First QC Date

July 19, 2022

Last Update Submit

February 10, 2023

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (12)

Change in body weight
From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Change in body weight
From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Change in waist circumference
From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Change in fasting plasma glucose (FPG)
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)
From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
+7 more secondary outcomes

Study Arms (1)

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

Interventions

SemaglutideDRUG

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.

Glucagon like peptide-1 (GLP-1) naive participants with Type 2 Diabetes (T2D)

Eligibility Criteria

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.