Clinical trial NCT02967757: In-market Utilisation of Liraglutide Used for Weight Management in Europe
Official title: In-market Utilisation of Liraglutide Used for Weight Management in Europe: a Retrospective Medical Record Review Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-11-18
Enrollment: 316
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a descriptive study designed to examine in-market utilisation of liraglutide; thus there will be no hypothesis testing and a power calculation is not applicable. 100 patients will be enrolled for the pilot study (50 in each country, ) and additionally 300 patients will be enrolled for the full study (150 in each country)

Brief summary: This study is conducted in Europe. The aim of this study is to investigate usage of liraglutide for weight management in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Initiation of liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg (initiation is defined as no prescription of the same brand within the previous 12 months)
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability of the study

Exclusion Criteria:

-Patients or physicians who previously participated in interventional studies for liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg will not be eligible to participate in the study -For the full study, sites and patients included in the pilot will be excluded

Primary outcomes:
measure: Number of patients with BMI above or equal to 30 kg/m^2
timeFrame: Less than 6 months before date of first prescription
measure: Number of patients with BMI above or equal to 27kg/m^2 and below 30 kg/m^2 and 1 or more comorbidity
timeFrame: Less than 6 months before date of first prescription
measure: Number of patients with above or equal to 27 kg/m^2 and below 30 kg/m^2 and no comorbidities
timeFrame: Less than 6 months before date of first prescription
measure: Number of patients with BMI below 27 kg/m^2
timeFrame: Less than 6 months before date of first prescription
measure: Number of patients with BMI not measured
timeFrame: Within 6 months before date of the first prescription
Secondary outcomes:
measure: Number of patients with liraglutide 1.2 or 1.8 mg prescriptions with dose information of 3.0 mg per day
timeFrame: From date of first prescription until 24 months
measure: Number of patients with liraglutide 1.2 or 1.8 mg prescriptions and indication of weight management
timeFrame: From date of first prescription until 24 months
measure: Number of patients with liraglutide 3.0 mg prescriptions who have reached a dose of 3.0 mg
timeFrame: By 12 weeks after first prescription date
measure: Number of patients with liraglutide 3.0 mg prescriptions and other GLP-1 receptor agonists prescribed during continued treatment with liraglutide 3.0 mg
timeFrame: From date of first prescription until 24 months
measure: Number of patients with continued treatment with liraglutide 3.0 mg
timeFrame: From date of first prescription until 0-6 weeks; 7-12 weeks; 13-18 weeks; 19-24 months
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Bünde
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Kaiserslautern
country: Germany
facility: Novo Nordisk Investigational Site
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: München
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Ulm
country: Germany
facility: Novo Nordisk Investigational Site
city: Catania
country: Italy
facility: Novo Nordisk Investigational Site
city: Chieti
country: Italy
facility: Novo Nordisk Investigational Site
city: Cremona
country: Italy
facility: Novo Nordisk Investigational Site
city: Novara
country: Italy
facility: Novo Nordisk Investigational Site
city: Pisa
country: Italy
facility: Novo Nordisk Investigational Site
city: Potenza
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Rome
country: Italy
facility: Novo Nordisk Investigational Site
city: Rome
country: Italy
facility: Novo Nordisk Investigational Site
city: Siena
country: Italy
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References:
citation: Sbraccia P, Aberle J, Olsen AH, Rathor N, Major-Pedersen A. Investigating the potential non-authorized use of two different formulations of liraglutide in Europe: A real-world drug utilization study. Diabetes Obes Metab. 2023 Apr;25(4):985-991. doi: 10.1111/dom.14945. Epub 2023 Jan 23.