<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/NCT02255266</url>
  </required_header>
  <id_info>
    <org_study_id>NN2211-4118</org_study_id>
    <secondary_id>U1111-1143-9842</secondary_id>
    <nct_id>NCT02255266</nct_id>
  </id_info>
  <brief_title>Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice</brief_title>
  <official_title>Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice</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 Long-Term&#xD;
      Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 26, 2015</start_date>
  <completion_date type="Actual">November 16, 2015</completion_date>
  <primary_completion_date type="Actual">November 16, 2015</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>Frequency of patients achieving HbA1c reduction of at least 1%-point</measure>
    <time_frame>Week 0, week 52</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c (Glycosylated haemoglobin))</measure>
    <time_frame>Week 0, week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Week 0, week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of patients achieving HbA1c reduction of at least 1%-point</measure>
    <time_frame>After 4 and 24 months of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of patients achieving HbA1c target (&lt;=7%)</measure>
    <time_frame>After 4, 12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of patients achieving a body weight reduction of at least 3%</measure>
    <time_frame>After 4, 12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of patients achieving the composite endpoint consisting in: HbA1c reduction of at least 1%-point and body weight reduction of at least 3%</measure>
    <time_frame>After 4, 12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of treatment discontinuation for any reason</measure>
    <time_frame>At 4, 12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure and lipid profile</measure>
    <time_frame>Week 0, week 104</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1788</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>liraglutide</intervention_name>
    <description>No treatment given.</description>
    <arm_group_label>A</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive subjects initiating liraglutide in 2011 according to Victoza® SmPC meeting&#xD;
        the inclusion criteria will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects of age above 18 years as per Victoza® SmPC par.4.2 and 5.1 diagnosed with&#xD;
             type 2 diabetes receiving the first prescription of liraglutide in 2011&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None. Available data from all eligible patients for each center, will be included&#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>Rome</city>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <results_reference>
    <citation>Lapolla A, Berra C, Boemi M, Bossi AC, Candido R, Di Cianni G, Frontoni S, Genovese S, Ponzani P, Provenzano V, Russo GT, Sciangula L, Simioni N, Bette C, Nicolucci A; NN2211-4118 Study Group. Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study. Adv Ther. 2018 Feb;35(2):243-253. doi: 10.1007/s12325-017-0652-2. Epub 2017 Dec 21.</citation>
    <PMID>29270781</PMID>
  </results_reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>April 16, 2018</last_update_submitted>
  <last_update_submitted_qc>April 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT02255266
org study id: NN2211-4118
secondary id: U1111-1143-9842
nct id: NCT02255266
lead sponsor: 
has dmc: No
This study is conducted in Europe. The aim of this study is to investigate Long-Term
      Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.
observational model: Cohort
time perspective: Retrospective
measure: Frequency of patients achieving HbA1c reduction of at least 1%-point
time frame: Week 0, week 52
measure: Change in HbA1c (Glycosylated haemoglobin))
time frame: Week 0, week 104
measure: Change in body weight
time frame: Week 0, week 104
measure: Frequency of patients achieving HbA1c reduction of at least 1%-point
time frame: After 4 and 24 months of treatment
measure: Frequency of patients achieving HbA1c target (<=7%)
time frame: After 4, 12 and 24 months
measure: Frequency of patients achieving a body weight reduction of at least 3%
time frame: After 4, 12 and 24 months
measure: Frequency of patients achieving the composite endpoint consisting in: HbA1c reduction of at least 1%-point and body weight reduction of at least 3%
time frame: After 4, 12 and 24 months
measure: Percentage of treatment discontinuation for any reason
time frame: At 4, 12 and 24 months
measure: Changes in blood pressure and lipid profile
time frame: Week 0, week 104
arm group label: A
intervention type: Drug
intervention name: liraglutide
description: No treatment given.
arm group label: A
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: 
country: Italy
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
citation: Lapolla A, Berra C, Boemi M, Bossi AC, Candido R, Di Cianni G, Frontoni S, Genovese S, Ponzani P, Provenzano V, Russo GT, Sciangula L, Simioni N, Bette C, Nicolucci A; NN2211-4118 Study Group. Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study. Adv Ther. 2018 Feb;35(2):243-253. doi: 10.1007/s12325-017-0652-2. Epub 2017 Dec 21.
PMID: 29270781
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Liraglutide