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

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ClinicalTrials.gov Identifier: NCT02967757
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Metabolism and Nutrition Disorder Obesity Drug: liraglutide

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Study Type : Observational
Actual Enrollment : 316 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: In-market Utilisation of Liraglutide Used for Weight Management in Europe: a Retrospective Medical Record Review Study.
Actual Study Start Date : December 22, 2016
Actual Primary Completion Date : May 28, 2019
Actual Study Completion Date : May 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Liraglutide

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967757


Locations
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Germany
Novo Nordisk Investigational Site
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
Italy
Novo Nordisk Investigational Site
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02967757     History of Changes
Other Study ID Numbers: NN8022-4241
U1111-1185-3661 ( Other Identifier: WHO )
EUPAS16225 ( Registry Identifier: EU PAS Register )
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Nutrition Disorders
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists