<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/NCT02207348</url>
  </required_header>
  <id_info>
    <org_study_id>NN8022-4162</org_study_id>
    <secondary_id>2014-000216-34</secondary_id>
    <secondary_id>U1111-1152-1391</secondary_id>
    <nct_id>NCT02207348</nct_id>
  </id_info>
  <brief_title>Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors</brief_title>
  <official_title>A Randomised, Open-label, Single-centre, Two-period, Cross-over Trial Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors</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 trial is conducted in Europe. The aim of this trial is to investigate bioequivalence&#xD;
      between single-dose liraglutide administered subcutaneously with two different pen-injectors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the liraglutide plasma concentration time curve from 0 to last quantifiable observation (tz) after single dose</measure>
    <time_frame>0-72 hours following administration of 0.6 mg liraglutide</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed liraglutide plasma concentration after single dose</measure>
    <time_frame>0-72 hours following administration of 0.6 mg liraglutide</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of treatment emergent adverse events (TEAEs)</measure>
    <time_frame>From baseline to follow-up (up to 3 weeks). Baseline is defined as time of first trial drug administration at Visit 2</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Metabolism and Nutrition Disorder</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Liraglutide 0.6 mg s.c. with FlexPen®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Liraglutide 0.6 mg s.c. with the PDS290 pen-injector</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>liraglutide</intervention_name>
    <description>Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors)</description>
    <arm_group_label>Liraglutide 0.6 mg s.c. with FlexPen®</arm_group_label>
    <arm_group_label>Liraglutide 0.6 mg s.c. with the PDS290 pen-injector</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age 18-60 years (both inclusive) at the time of signing informed&#xD;
             consent&#xD;
&#xD;
          -  Body mass index (BMI) greater than or equal to 27.0 and less than 35.0 kg/m^2&#xD;
&#xD;
          -  Bodyweight up to 130.0 kg (inclusive)&#xD;
&#xD;
          -  HbA1c (glycosylated haemoglobin) below 6.5%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of&#xD;
             child-bearing potential and not using an adequate contraceptive method. Only highly&#xD;
             effective methods of birth control are accepted (i.e. one that results in less than 1%&#xD;
             per year failure rate when used consistently and correctly such as implants,&#xD;
             injectables, combined oral contraceptives, some intrauterine devices), or sexual&#xD;
             abstinence or vasectomised partner&#xD;
&#xD;
          -  History or presence of cancer, or any clinically significant cardiovascular,&#xD;
             respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes),&#xD;
             haematological, dermatological, venereal, neurological, psychiatric diseases or other&#xD;
             major disorders that might have impact on the trial, as judged by the investigator&#xD;
&#xD;
          -  Use of any prescription or non-prescription medication, except for paracetamol,&#xD;
             acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin&#xD;
             therapy, as judged by the investigator) within 2 weeks before the trial defined as&#xD;
             screening&#xD;
&#xD;
          -  Significant history of alcoholism or drug/chemical abuse within 1 year from screening,&#xD;
             or a positive result of the urine drug screen or alcohol breath test, or consuming&#xD;
             more than 21 units of alcohol per week (one unit of alcohol equals about 250 mL of&#xD;
             beer or lager, one glass of wine (120 mL), or 20 mL spirits)&#xD;
&#xD;
          -  Smoking more than 5 cigarettes, or the equivalent, per day and unable to refrain from&#xD;
             smoking during the in-house periods&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</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>Neuss</city>
        <zip>41460</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</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/NCT02207348
org study id: NN8022-4162
secondary id: 2014-000216-34
secondary id: U1111-1152-1391
nct id: NCT02207348
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of this trial is to investigate bioequivalence
      between single-dose liraglutide administered subcutaneously with two different pen-injectors.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the liraglutide plasma concentration time curve from 0 to last quantifiable observation (tz) after single dose
time frame: 0-72 hours following administration of 0.6 mg liraglutide
measure: Maximum observed liraglutide plasma concentration after single dose
time frame: 0-72 hours following administration of 0.6 mg liraglutide
measure: Number of treatment emergent adverse events (TEAEs)
time frame: From baseline to follow-up (up to 3 weeks). Baseline is defined as time of first trial drug administration at Visit 2
arm group label: Liraglutide 0.6 mg s.c. with FlexPen®
arm group type: Experimental
arm group label: Liraglutide 0.6 mg s.c. with the PDS290 pen-injector
arm group type: Experimental
intervention type: Drug
intervention name: liraglutide
description: Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors)
arm group label: Liraglutide 0.6 mg s.c. with FlexPen®
arm group label: Liraglutide 0.6 mg s.c. with the PDS290 pen-injector
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: Germany
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
responsible party type: Sponsor
mesh term: Nutrition Disorders
mesh term: Liraglutide