Study type

Study topic

Human medicinal product

Study topic, other

GLP-1 agonists shortage

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

OZEMPIC
SAXENDA
TRULICITY
VICTOZA

Name of medicine, other

GLP-1 agonists

Study drug International non-proprietary name (INN) or common name

DULAGLUTIDE
LIRAGLUTIDE
SEMAGLUTIDE

Anatomical Therapeutic Chemical (ATC) code

(A10BJ) Glucagon-like peptide-1 (GLP-1) analogues
Glucagon-like peptide-1 (GLP-1) analogues
Population studied

Short description of the study population

Population-level drug utilisation of GLP-1 RA and medicines used for weight loss that help contextualise exposure to GLP-1 RA: All individuals present in the database in the last 10 years of available data will be included in the analysis. For this population, incidence and prevalence of use of GLP-1 RA and medicines used for weight loss that help contextualise exposure to GLP-1 RA will be explored.
Patient level cohort study on GLP-1 RA users stratified by presence or absence of diabetes mellitus type 2 and/or obesity: new drug users of GLP-1 RA stratified by presence or absence of diagnosis of diabetes mellitus type 2 and/or diagnosis of obesity will be characterised by age, sex, body mass index, initial dose, cumulative dose and a list of prespecified indications/comorbidities.
Study design details

Study design

Retrospective cohort studies will be conducted using routinely collected health data from five databases.

Main study objective

This study aims to provide an overview of the characteristics of patients prescribed with a GLP-1 RA medicinal product and how these have changed over the past ten years.
The specific objectives of this study are:
1) To determine the incidence and prevalence of prescriptions of GLP-1 RA medicinal products (overall and stratified by age, sex, database, indications (only for incidence), and calendar time (per month), for the past 10 years. Additionally, new drug users of GLP-1 RA (stratified by presence or absence of diagnosis of diabetes mellitus type 2 and diagnosis of obesity indications) will be characterised by age, sex, body mass index, initial dose, cumulative dose and a list of prespecified indications.

2) To determine the incidence and prevalence of prescriptions of medicines used for weight loss that help contextualise exposure to GLP-1 RA, including orlistat, naltrexone/bupropion, phentermine/topiramate, phentermine and metformin (overall and stratified by age, sex, database, and calendar time (per month), for the past 10 years.
Documents
Study report
English (6.31 MB - PDF)View document