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)

February 10, 2023 updated by: Novo Nordisk A/S

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
314

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in glycated haemoglobin (HbA1c)
Time Frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Measured as percentage (%) point.
From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Measured in kilograms (kg).
From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Change in body weight
Time Frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Measured as percentage (%).
From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Change in waist circumference
Time Frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Measured in centimeter (cm).
From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Change in fasting plasma glucose (FPG)
Time Frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
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)
Time Frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
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)
Time Frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
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%
Time Frame: At end of follow-up (week 30 +- 4 weeks)
Measured as Yes/No.
At end of follow-up (week 30 +- 4 weeks)
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)
Measured as Yes/No.
From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Weight loss >= 5%
Time Frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Measured as Yes/No.
From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Weight loss >= 3%
Time Frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
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%
Time Frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Measured as Yes/No.
From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Having at least 1 severe hypoglycaemic episode
Time Frame: At end of follow-up (week 30 +- 4 weeks)
Measured as Yes/No.
At end of follow-up (week 30 +- 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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