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Completed

NCT Number: NCT02967757

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

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

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Key information

Conditions

Metabolism and Nutrition Disorder Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Bad Nauheim, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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

Primary outcomes

  1. Number of patients with BMI above or equal to 30 kg/m^2

    Time frame: Less than 6 months before date of first prescription

  2. 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

  3. 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.

  4. Number of patients with BMI below 27 kg/m^2

    Time frame: Less than 6 months before date of first prescription

  5. Number of patients with BMI not measured

    Time frame: Within 6 months before date of the first prescription

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 18, 2016
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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