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

Overview

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

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: May 28, 2019

Interventions

  • 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

Arms, Groups and Cohorts

  • liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients with BMI above or equal to 30 kg/m^2
    • Time Frame: 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
  • 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.
  • Number of patients with BMI below 27 kg/m^2
    • Time Frame: 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

Secondary Measures

  • 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
  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novo Nordisk A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Global Clinical Registry (GCR,1452), Study Director, Novo Nordisk A/S

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