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)

NCT ID: NCT05468632

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-05

Study Completion Date

2022-07-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Semaglutide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Bitola, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Debar, , North Macedonia

Site Status

Novo Nordisk Investigational Site

General Hospital Kavadarci, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Gostivar, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Kičevo, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Kočani, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Kumanovo, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Ohrid, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Prilep, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Shtip, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Skopje, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Skopje, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Skopje, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Struga, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Stumica, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Tetovo, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Veles, , North Macedonia

Site Status

Countries

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North Macedonia

Other Identifiers

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U1111-1273-4429

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-4976

Identifier Type: -

Identifier Source: org_study_id

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