<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02967757</url>
  </required_header>
  <id_info>
    <org_study_id>NN8022-4241</org_study_id>
    <secondary_id>U1111-1185-3661</secondary_id>
    <secondary_id>EUPAS16225</secondary_id>
    <nct_id>NCT02967757</nct_id>
  </id_info>
  <brief_title>In-market Utilisation of Liraglutide Used for Weight Management in Europe</brief_title>
  <official_title>In-market Utilisation of Liraglutide Used for Weight Management in Europe: a Retrospective Medical Record Review Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is conducted in Europe. The aim of this study is to investigate usage of&#xD;
      liraglutide for weight management in clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2016</start_date>
  <completion_date type="Actual">May 28, 2019</completion_date>
  <primary_completion_date type="Actual">May 28, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with BMI above or equal to 30 kg/m^2</measure>
    <time_frame>Less than 6 months before date of first prescription</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with BMI above or equal to 27kg/m^2 and below 30 kg/m^2 and 1 or more comorbidity</measure>
    <time_frame>Less than 6 months before date of first prescription</time_frame>
    <description>Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with above or equal to 27 kg/m^2 and below 30 kg/m^2 and no comorbidities</measure>
    <time_frame>Less than 6 months before date of first prescription</time_frame>
    <description>Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with BMI below 27 kg/m^2</measure>
    <time_frame>Less than 6 months before date of first prescription</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with BMI not measured</measure>
    <time_frame>Within 6 months before date of the first prescription</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with liraglutide 1.2 or 1.8 mg prescriptions with dose information of 3.0 mg per day</measure>
    <time_frame>From date of first prescription until 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with liraglutide 1.2 or 1.8 mg prescriptions and indication of weight management</measure>
    <time_frame>From date of first prescription until 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with liraglutide 3.0 mg prescriptions who have reached a dose of 3.0 mg</measure>
    <time_frame>By 12 weeks after first prescription date</time_frame>
    <description>While adhering to the dose escalation according to label</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with liraglutide 3.0 mg prescriptions and other GLP-1 receptor agonists prescribed during continued treatment with liraglutide 3.0 mg</measure>
    <time_frame>From date of first prescription until 24 months</time_frame>
    <description>Number of patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with continued treatment with liraglutide 3.0 mg</measure>
    <time_frame>From date of first prescription until 0-6 weeks; 7-12 weeks; 13-18 weeks; 19-24 months</time_frame>
    <description>Number of patients</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">316</enrollment>
  <condition>Metabolism and Nutrition Disorder</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>liraglutide</intervention_name>
    <description>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</description>
    <arm_group_label>liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This is a descriptive study designed to examine in-market utilisation of liraglutide; thus&#xD;
        there will be no hypothesis testing and a power calculation is not applicable. 100 patients&#xD;
        will be enrolled for the pilot study (50 in each country, ) and additionally 300 patients&#xD;
        will be enrolled for the full study (150 in each country)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Initiation of liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg (initiation is defined as&#xD;
             no prescription of the same brand within the previous 12 months)&#xD;
&#xD;
          -  Informed consent obtained before any study-related activities. Study-related&#xD;
             activities are any procedures that are carried out as part of the study, including&#xD;
             activities to determine suitability of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Patients or physicians who previously participated in interventional studies for&#xD;
        liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg will not be eligible to participate in the&#xD;
        study -For the full study, sites and patients included in the pilot will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry (GCR,1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bünde</city>
        <zip>32257</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20097</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kaiserslautern</city>
        <zip>67655</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mainz</city>
        <zip>55124</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>München</city>
        <zip>81477</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Münster</city>
        <zip>48143</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ulm</city>
        <zip>89073</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Catania</city>
        <zip>95122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chieti</city>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cremona</city>
        <zip>26900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Potenza</city>
        <zip>85100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Roma</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rome</city>
        <zip>161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Sbraccia P, Aberle J, Olsen AH, Rathor N, Major-Pedersen A. Investigating the potential non-authorized use of two different formulations of liraglutide in Europe: A real-world drug utilization study. Diabetes Obes Metab. 2023 Apr;25(4):985-991. doi: 10.1111/dom.14945. Epub 2023 Jan 23.</citation>
    <PMID>36514273</PMID>
  </results_reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>January 19, 2023</last_update_submitted>
  <last_update_submitted_qc>January 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nutrition Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liraglutide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02967757
org study id: NN8022-4241
secondary id: U1111-1185-3661
secondary id: EUPAS16225
nct id: NCT02967757
lead sponsor: 
has dmc: No
This study is conducted in Europe. The aim of this study is to investigate usage of
      liraglutide for weight management in clinical practice.
observational model: Cohort
time perspective: Retrospective
measure: Number of patients with BMI above or equal to 30 kg/m^2
time frame: Less than 6 months before date of first prescription
measure: 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
description: Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities
measure: 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
description: Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities.
measure: Number of patients with BMI below 27 kg/m^2
time frame: Less than 6 months before date of first prescription
measure: Number of patients with BMI not measured
time frame: Within 6 months before date of the first prescription
measure: 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
measure: 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
measure: 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
description: While adhering to the dose escalation according to label
measure: 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
description: Number of patients
measure: 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
description: Number of patients
arm group label: liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg
intervention type: Drug
intervention name: liraglutide
description: 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
arm group label: liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Registry (GCR,1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Italy
citation: Sbraccia P, Aberle J, Olsen AH, Rathor N, Major-Pedersen A. Investigating the potential non-authorized use of two different formulations of liraglutide in Europe: A real-world drug utilization study. Diabetes Obes Metab. 2023 Apr;25(4):985-991. doi: 10.1111/dom.14945. Epub 2023 Jan 23.
PMID: 36514273
responsible party type: Sponsor
mesh term: Nutrition Disorders
mesh term: Liraglutide