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)

Diabetes Mellitus, Type 2 Clinical Trial

— MIRAGE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05468632
• Other study ID #: NN9535-4976
• Secondary ID: U1111-1273-4429
• Status: Completed
• Start date: July 5, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
North Macedonia	Novo Nordisk Investigational Site	Bitola
North Macedonia	Novo Nordisk Investigational Site	Debar
North Macedonia	Novo Nordisk Investigational Site	General Hospital Kavadarci
North Macedonia	Novo Nordisk Investigational Site	Gostivar
North Macedonia	Novo Nordisk Investigational Site	Kicevo
North Macedonia	Novo Nordisk Investigational Site	Kochani
North Macedonia	Novo Nordisk Investigational Site	Kumanovo
North Macedonia	Novo Nordisk Investigational Site	Ohrid
North Macedonia	Novo Nordisk Investigational Site	Prilep
North Macedonia	Novo Nordisk Investigational Site	Shtip
North Macedonia	Novo Nordisk Investigational Site	Skopje
North Macedonia	Novo Nordisk Investigational Site	Skopje
North Macedonia	Novo Nordisk Investigational Site	Skopje
North Macedonia	Novo Nordisk Investigational Site	Struga
North Macedonia	Novo Nordisk Investigational Site	Stumica
North Macedonia	Novo Nordisk Investigational Site	Tetovo
North Macedonia	Novo Nordisk Investigational Site	Veles

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

North Macedonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycated haemoglobin (HbA1c)	Measured as percentage (%) point.	From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Secondary	Change in body weight	Measured in kilograms (kg).	From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Secondary	Change in body weight	Measured as percentage (%).	From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Secondary	Change in waist circumference	Measured in centimeter (cm).	From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Secondary	Change in fasting plasma glucose (FPG)	Measured in millimoles per liter (mmol/l).	From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Secondary	Change in Lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides)	Measured in millimoles per liter (mmol/L).	From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Secondary	Change in Blood Pressure (systolic and diastolic)	Measured in millimiters of mercury (mmHg).	From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Secondary	Glycated haemoglobin (HbA1c) less than 7%	Measured as Yes/No.	At end of follow-up (week 30 +- 4 weeks)
Secondary	Reduction in glycated haemoglobin (HbA1c) greater than or equal to (>=) 1%	Measured as Yes/No.	From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Secondary	Weight loss >= 5%	Measured as Yes/No.	From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Secondary	Weight loss >= 3%	Measured as Yes/No.	From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Secondary	HbA1c reduction >= 1% and weight loss of >=3%	Measured as Yes/No.	From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Secondary	Having at least 1 severe hypoglycaemic episode	Measured as Yes/No.	At end of follow-up (week 30 +- 4 weeks)