<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/NCT02231658</url>
  </required_header>
  <id_info>
    <org_study_id>GI-Motil</org_study_id>
    <nct_id>NCT02231658</nct_id>
  </id_info>
  <brief_title>Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion</brief_title>
  <official_title>Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Profil Institut für Stoffwechselforschung GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Profil Institut für Stoffwechselforschung GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study will compare lixisenatide and liraglutide in a population of subjects with&#xD;
      T2DM not optimally controlled on OADs and / or insulin, which is the target population for&#xD;
      these medications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Too challenging to recruit appropriate participants at an acceptable speed.&#xD;
  </why_stopped>
  <start_date type="Actual">July 16, 2015</start_date>
  <completion_date type="Actual">July 23, 2018</completion_date>
  <primary_completion_date type="Actual">July 23, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline (week -1) in the number of reflux episodes</measure>
    <time_frame>24 hours after 10 weeks of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline (week -1) in the time of pH &lt; 4.0 in the lower third of the oesophagus</measure>
    <time_frame>After 10 weeks of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Liraglutide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The highest injected once daily dose will be 1.8 mg s.c. for liraglutide.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lixisenatide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The highest injected once daily dose will be 20µg s.c. for lixisenatide.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liraglutide</intervention_name>
    <arm_group_label>Liraglutide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lixisenatide</intervention_name>
    <arm_group_label>Lixisenatide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained before any trial-related activities. Trial-related&#xD;
             activities are any procedures that are carried out as part of the trial, including&#xD;
             activities to determine suitability for the trial.&#xD;
&#xD;
          -  Male or female aged 18-65 years (both inclusive)&#xD;
&#xD;
          -  T2DM diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications (including known or suspected hypersensitivity) to GLP-1 mimetics&#xD;
&#xD;
          -  Use of GLP-1 mimetics or DPP-IV inhibitors&#xD;
&#xD;
          -  Clinically relevant dysglycaemia as indicated by HbA1C ≥ 10%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juris Meier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Josef Hospital Bochum</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Josef-Hospital, Universitätsklinik</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Profil Institut für Stoffwechselforschung GmbH</name>
      <address>
        <city>Neuss</city>
        <zip>41460</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 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>Gastroesophageal Reflux</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liraglutide</mesh_term>
    <mesh_term>Lixisenatide</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/NCT02231658
org study id: GI-Motil
nct id: NCT02231658
lead sponsor: 
has dmc: No
The present study will compare lixisenatide and liraglutide in a population of subjects with
      T2DM not optimally controlled on OADs and / or insulin, which is the target population for
      these medications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change from baseline (week -1) in the number of reflux episodes
time frame: 24 hours after 10 weeks of treatment
measure: Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus
time frame: After 10 weeks of treatment
arm group label: Liraglutide
arm group type: Experimental
description: The highest injected once daily dose will be 1.8 mg s.c. for liraglutide.
arm group label: Lixisenatide
arm group type: Experimental
description: The highest injected once daily dose will be 20µg s.c. for lixisenatide.
intervention type: Drug
intervention name: Liraglutide
arm group label: Liraglutide
intervention type: Drug
intervention name: Lixisenatide
arm group label: Lixisenatide
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Juris Meier, MD
role: Principal Investigator
affiliation: St. Josef Hospital Bochum
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Liraglutide
mesh term: Lixisenatide