Clinical trial NCT05468632: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-07-21
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
Secondary outcomes:
measure: Change in body weight
timeFrame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
measure: Change in body weight
timeFrame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
measure: Change in fasting plasma glucose (FPG)
timeFrame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
measure: Change in Lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides)
timeFrame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
measure: Change in Blood Pressure (systolic and diastolic)
timeFrame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
measure: Glycated haemoglobin (HbA1c) less than 7%
timeFrame: At end of follow-up (week 30 +- 4 weeks)
measure: Reduction in glycated haemoglobin (HbA1c) greater than or equal to (>=) 1%
timeFrame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
measure: Weight loss >= 5%
timeFrame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
measure: Weight loss >= 3%
timeFrame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
measure: HbA1c reduction >= 1% and weight loss of >=3%
timeFrame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)
measure: Having at least 1 severe hypoglycaemic episode
timeFrame: At end of follow-up (week 30 +- 4 weeks)
Other outcomes:
Locations:
city: Bitola
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Debar
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: General Hospital Kavadarci
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Gostivar
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Kicevo
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Kochani
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Kumanovo
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Ohrid
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Prilep
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Shtip
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Skopje
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Skopje
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Skopje
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Struga
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Stumica
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Tetovo
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Veles
country: North Macedonia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: