In-market Utilisation of Liraglutide Used for Weight Management in Europe

Obesity Clinical Trial

Official title:

In-market Utilisation of Liraglutide Used for Weight Management in Europe: a Retrospective Medical Record Review Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967757
• Other study ID #: NN8022-4241
• Secondary ID: U1111-1185-3661E
• Status: Completed
• Start date: December 22, 2016
• Est. completion date: May 28, 2019

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: May 28, 2019
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity

Intervention

Drug:
• liraglutide
Patients will be treated according to routine clinical practice at the discretion of the treating physician. The study will gather data over the course of routine treatment for liraglutide 3.0 mg and liraglutide 1.2 mg/1.8 mg treated patients

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Bad Nauheim
Germany	Novo Nordisk Investigational Site	Bünde
Germany	Novo Nordisk Investigational Site	Essen
Germany	Novo Nordisk Investigational Site	Hamburg
Germany	Novo Nordisk Investigational Site	Kaiserslautern
Germany	Novo Nordisk Investigational Site	Mainz
Germany	Novo Nordisk Investigational Site	München
Germany	Novo Nordisk Investigational Site	Münster
Germany	Novo Nordisk Investigational Site	Ulm
Italy	Novo Nordisk Investigational Site	Catania
Italy	Novo Nordisk Investigational Site	Chieti
Italy	Novo Nordisk Investigational Site	Cremona
Italy	Novo Nordisk Investigational Site	Novara
Italy	Novo Nordisk Investigational Site	Pisa
Italy	Novo Nordisk Investigational Site	Potenza
Italy	Novo Nordisk Investigational Site	Roma
Italy	Novo Nordisk Investigational Site	Rome
Italy	Novo Nordisk Investigational Site	Rome
Italy	Novo Nordisk Investigational Site	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Germany,  Italy, 

References & Publications (1)

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. 2022 Dec 13. doi: 10.1111/dom.1494 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with BMI above or equal to 30 kg/m^2		Less than 6 months before date of first prescription
Primary	Number of patients with BMI above or equal to 27kg/m^2 and below 30 kg/m^2 and 1 or more comorbidity	Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities	Less than 6 months before date of first prescription
Primary	Number of patients with above or equal to 27 kg/m^2 and below 30 kg/m^2 and no comorbidities	Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities.	Less than 6 months before date of first prescription
Primary	Number of patients with BMI below 27 kg/m^2		Less than 6 months before date of first prescription
Primary	Number of patients with BMI not measured		Within 6 months before date of the first prescription
Secondary	Number of patients with liraglutide 1.2 or 1.8 mg prescriptions with dose information of 3.0 mg per day		From date of first prescription until 24 months
Secondary	Number of patients with liraglutide 1.2 or 1.8 mg prescriptions and indication of weight management		From date of first prescription until 24 months
Secondary	Number of patients with liraglutide 3.0 mg prescriptions who have reached a dose of 3.0 mg	While adhering to the dose escalation according to label	By 12 weeks after first prescription date
Secondary	Number of patients with liraglutide 3.0 mg prescriptions and other GLP-1 receptor agonists prescribed during continued treatment with liraglutide 3.0 mg	Number of patients	From date of first prescription until 24 months
Secondary	Number of patients with continued treatment with liraglutide 3.0 mg	Number of patients	From date of first prescription until 0-6 weeks; 7-12 weeks; 13-18 weeks; 19-24 months