MIRAGE: A North Macedonian Study Investigating Retrospective Data of Glucagon-like Peptide-1 (GLP-1) Participanta With Type 2 Diabetes (T2D) in Real World Environment (RWE) Setting

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05468632
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Actual Duration (Days): 26
• Patients Per Site Per Month: 409.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Semaglutide

Study Design

• Study Type: Observational
• Actual Enrollment: 350 participants
• Observational Model: Other
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: Jul 5, 2022
• Actual Primary Completion Date: Jul 31, 2022
• Actual Study Completion Date: Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Change in glycated haemoglobin (HbA1c) [From baseline (week 0) to end of follow-up (week 30+- 4 weeks)]

   Measured as percentage (%) point.

Secondary Outcome Measures

1. Change in body weight [From baseline (week 0) to end of follow-up (week 30+- 4 weeks)]

   Measured in kilograms (kg).

2. Change in body weight [From baseline (week 0) to end of follow-up (week 30+- 4 weeks)]

   Measured as percentage (%).

3. Change in waist circumference [From baseline (week 0) to end of follow-up (week 30+- 4 weeks)]

   Measured in centimeter (cm).

4. Change in fasting plasma glucose (FPG) [From baseline (week 0) to end of follow-up (week 30+- 4 weeks)]

   Measured in millimoles per liter (mmol/l).

5. 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)]

   Measured in millimoles per liter (mmol/L).

6. Change in Blood Pressure (systolic and diastolic) [From baseline (week 0) to end of follow-up (week 30+- 4 weeks)]

   Measured in millimiters of mercury (mmHg).

7. Glycated haemoglobin (HbA1c) less than 7% [At end of follow-up (week 30 +- 4 weeks)]

   Measured as Yes/No.

8. Reduction in glycated haemoglobin (HbA1c) greater than or equal to (>=) 1% [From baseline (week 0) to end of follow-up (week 30+- 4 weeks)]

   Measured as Yes/No.

9. Weight loss >= 5% [From baseline (week 0) to end of follow-up (week 30+- 4 weeks)]

   Measured as Yes/No.

10. Weight loss >= 3% [From baseline (week 0) to end of follow-up (week 30+- 4 weeks)]

    Measured as Yes/No.

11. HbA1c reduction >= 1% and weight loss of >=3% [From baseline (week 0) to end of follow-up (week 30+- 4 weeks)]

    Measured as Yes/No.

12. Having at least 1 severe hypoglycaemic episode [At end of follow-up (week 30 +- 4 weeks)]

    Measured as Yes/No.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Skopje		North Macedonia	SK 1000

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT05468632
• Other Study ID Numbers: NN9535-4976; U1111-1273-4429
• First Posted: Jul 21, 2022
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 25, 2022