Diabetes Mellitus, Type 2MIRAGENCT05468632
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)
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 17 sites in North Macedonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide
- How many people
- 314 participants
- Where
- 17 sitesNorth Macedonia
- Study dates
- 5 Jul 2022to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Previous participation in this study.
- Prior use of GLP-1 within last one year.
- Participants with type-1 diabetes and gestational diabetes.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
North Macedonia17 sites
Novo Nordisk Investigational Site
Bitola, 7000
Novo Nordisk Investigational Site
Debar, 1250
Novo Nordisk Investigational Site
General Hospital Kavadarci, 1430
Novo Nordisk Investigational Site
Gostivar, 1230
Novo Nordisk Investigational Site
Kicevo, 6250
Novo Nordisk Investigational Site
Kočani, 2300
Novo Nordisk Investigational Site
Kumanovo, 1300
Novo Nordisk Investigational Site
Ohrid, 6000
Novo Nordisk Investigational Site
Prilep, 7500
Novo Nordisk Investigational Site
Shtip, 2000
Novo Nordisk Investigational Site
Skopje, 1 000
Novo Nordisk Investigational Site
Skopje, 1000
Novo Nordisk Investigational Site
Skopje, SK 1000
Novo Nordisk Investigational Site
Struga, 6330
Novo Nordisk Investigational Site
Stumica, 2400
Novo Nordisk Investigational Site
Tetovo, 1220
Novo Nordisk Investigational Site
Veles, 1400
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated haemoglobin (HbA1c)
Measured as percentage (%) point.
Measured: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Secondary outcomes (12)
Change in body weight
Measured in kilograms (kg).
Measured: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Change in body weight
Measured as percentage (%).
Measured: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Change in waist circumference
Measured in centimeter (cm).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Glycated haemoglobin (HbA1c) less than 7%
Measured as Yes/No.
Measured: At end of follow-up (week 30 +- 4 weeks)
Reduction in glycated haemoglobin (HbA1c) greater than or equal to (>=) 1%
Measured as Yes/No.
Measured: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Weight loss >= 5%
Measured as Yes/No.
Measured: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Weight loss >= 3%
Measured as Yes/No.
Measured: 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.
Measured: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Having at least 1 severe hypoglycaemic episode
Measured as Yes/No.
Measured: At end of follow-up (week 30 +- 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start5 Jul 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468632
- Sponsor's protocol ID
- NN9535-4976
- Other IDs
- U1111-1273-4429
- Acronym
- MIRAGE
- Status last verified
- Feb 2023
- First submitted
- 19 Jul 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05468632
- Acronym / sponsor ID
- MIRAGE / NN9535-4976
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glucagon like peptide-1 (GLP-1) naive participants with Type 2 Diabetes (T2D) | – | Drug: SemaglutideGlucagon 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Previous participation in this study.
- Prior use of GLP-1 within last one year.
- Participants with type-1 diabetes and gestational diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideParticipants 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. | Drug | Glucagon like peptide-1 (GLP-1) naive participants with Type 2 Diabetes (T2D) |
Primary outcome
Change in glycated haemoglobin (HbA1c)
Time frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Measured as percentage (%) point.
12 secondary outcomes
Change in body weight
Time frame: 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)
Change in waist circumference
Time frame: 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)
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 in Blood Pressure (systolic and diastolic)
Time frame: 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)
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)
Weight loss >= 5%
Time frame: 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)
HbA1c reduction >= 1% and weight loss of >=3%
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 17 sites in North Macedonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.