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

Completed

• Conditions: Metabolism and Nutrition Disorder; Obesity
• Interventions: Drug: liraglutide

• Registration Number: NCT02967757
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Study Start: 2016-12-22
• Primary Completion: 2019-05-28
• Study Completion: 2019-05-28
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Number of patients with BMI not measured	Within 6 months before date of the first prescription
Number of patients with BMI above or equal to 30 kg/m^2	Less than 6 months before date of first prescription
Number of patients with BMI above or equal to 27kg/m^2 and below 30 kg/m^2 and 1 or more comorbidity	Less than 6 months before date of first prescription	Dysglycaemia (Type 2 Diabetes Mellitus \[T2DM\] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities
Number of patients with above or equal to 27 kg/m^2 and below 30 kg/m^2 and no comorbidities	Less than 6 months before date of first prescription	Dysglycaemia (Type 2 Diabetes Mellitus \[T2DM\] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities.
Number of patients with BMI below 27 kg/m^2	Less than 6 months before date of first prescription

Secondary Outcome Measures

Name	Time	Method
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
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
Number of patients with liraglutide 3.0 mg prescriptions who have reached a dose of 3.0 mg	By 12 weeks after first prescription date	While adhering to the dose escalation according to label
Number of patients with liraglutide 3.0 mg prescriptions and other GLP-1 receptor agonists prescribed during continued treatment with liraglutide 3.0 mg	From date of first prescription until 24 months	Number of patients
Number of patients with continued treatment with liraglutide 3.0 mg	From date of first prescription until 0-6 weeks; 7-12 weeks; 13-18 weeks; 19-24 months	Number of patients

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇹 Siena, Italy