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

January 19, 2023 updated by: Novo Nordisk A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

316

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Nauheim, Germany, 61231
        • Novo Nordisk Investigational Site
      • Bünde, Germany, 32257
        • Novo Nordisk Investigational Site
      • Essen, Germany, 45147
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 20097
        • Novo Nordisk Investigational Site
      • Kaiserslautern, Germany, 67655
        • Novo Nordisk Investigational Site
      • Mainz, Germany, 55124
        • Novo Nordisk Investigational Site
      • München, Germany, 81477
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48143
        • Novo Nordisk Investigational Site
      • Ulm, Germany, 89073
        • Novo Nordisk Investigational Site
  • Italy
      • Catania, Italy, 95122
        • Novo Nordisk Investigational Site
      • Chieti, Italy, 66100
        • Novo Nordisk Investigational Site
      • Cremona, Italy, 26900
        • Novo Nordisk Investigational Site
      • Novara, Italy, 28100
        • Novo Nordisk Investigational Site
      • Pisa, Italy, 56126
        • Novo Nordisk Investigational Site
      • Potenza, Italy, 85100
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00128
        • Novo Nordisk Investigational Site
      • Rome, Italy, 00168
        • Novo Nordisk Investigational Site
      • Rome, Italy, 161
        • Novo Nordisk Investigational Site
      • Siena, Italy, 53100
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with BMI above or equal to 30 kg/m^2
Time Frame: Less than 6 months before date of first prescription
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
Time Frame: 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
Less than 6 months before date of first prescription
Number of patients with above or equal to 27 kg/m^2 and below 30 kg/m^2 and no comorbidities
Time Frame: 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.
Less than 6 months before date of first prescription
Number of patients with BMI below 27 kg/m^2
Time Frame: Less than 6 months before date of first prescription
Less than 6 months before date of first prescription
Number of patients with BMI not measured
Time Frame: Within 6 months before date of the first prescription
Within 6 months before date of the first prescription

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with liraglutide 1.2 or 1.8 mg prescriptions with dose information of 3.0 mg per day
Time Frame: From date of first prescription until 24 months
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
Time Frame: From date of first prescription until 24 months
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
Time Frame: By 12 weeks after first prescription date
While adhering to the dose escalation according to label
By 12 weeks after first prescription date
Number of patients with liraglutide 3.0 mg prescriptions and other GLP-1 receptor agonists prescribed during continued treatment with liraglutide 3.0 mg
Time Frame: From date of first prescription until 24 months
Number of patients
From date of first prescription until 24 months
Number of patients with continued treatment with liraglutide 3.0 mg
Time Frame: From date of first prescription until 0-6 weeks; 7-12 weeks; 13-18 weeks; 19-24 months
Number of patients
From date of first prescription until 0-6 weeks; 7-12 weeks; 13-18 weeks; 19-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2016

Primary Completion (Actual)

May 28, 2019

Study Completion (Actual)

May 28, 2019

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8022-4241
  • U1111-1185-3661 (Other Identifier: WHO)
  • EUPAS16225 (Registry Identifier: EU PAS Register)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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