<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/NCT02221323</url>
  </required_header>
  <id_info>
    <org_study_id>DBC-14LIPOINJ01</org_study_id>
    <nct_id>NCT02221323</nct_id>
  </id_info>
  <brief_title>A Trial to Compare the PK and PD of Insulin Lispro Administered Into Different Tissues in Subjects With Diabetes Mellitus Type 1</brief_title>
  <official_title>A Trial to Compare the Pharmacokinetics and Pharmacodynamics of Insulin Lispro Administered s.c. Into Lipohypertrophic or Normal Abdominal Adipose Tissue in Subjects With Diabetes Mellitus Type 1</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 aim of this trial is to compare the pharmacokinetics and pharmacodynamics of insulin&#xD;
      lispro injection into either lipohypertrophic lesions or normal tissue, utilizing both&#xD;
      state-of-the-art euglycaemic clamp and mixed meal tolerance testing. The magnitude of insulin&#xD;
      efficacy after injection into these different areas is still unclear. The results from this&#xD;
      study may expand the knowledge on the severity of this issue and may provide evidence for&#xD;
      future treatment recommendations regarding injection sites for insulin administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUCINS.0-4h and AUCGIR.0-4h</measure>
    <time_frame>up to 4 hours</time_frame>
    <description>Compare the pharmacokinetic and pharmacodynamic effects of insulin lispro during the first 4 hours after s.c.&#xD;
administration into either lipohypertrophic or normal adipose tissue during a euglycaemic clamp examination.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Insulin lispro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin LISPRO</intervention_name>
    <arm_group_label>Insulin lispro</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AUCINS.0-4h and AUCGIR.0-4h during treatment period 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AUCINS.0-4h and AUCBG.0-4h during treatment period 2, intra-subject variability of&#xD;
             AUCINS.0-4h and AUCGIR.0-4h during treatment period 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulrike Hövelmann</last_name>
    <role>Principal Investigator</role>
    <affiliation>Profil Institut für Stoffwechselforschung GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Profil Institut für Stoffwechselforschung GmbH</name>
      <address>
        <city>Neuss</city>
        <state>NRW</state>
        <zip>41460</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>December 29, 2014</last_update_submitted>
  <last_update_submitted_qc>December 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2014</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 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Lispro</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/NCT02221323
org study id: DBC-14LIPOINJ01
nct id: NCT02221323
lead sponsor: 
has dmc: No
The aim of this trial is to compare the pharmacokinetics and pharmacodynamics of insulin
      lispro injection into either lipohypertrophic lesions or normal tissue, utilizing both
      state-of-the-art euglycaemic clamp and mixed meal tolerance testing. The magnitude of insulin
      efficacy after injection into these different areas is still unclear. The results from this
      study may expand the knowledge on the severity of this issue and may provide evidence for
      future treatment recommendations regarding injection sites for insulin administration.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: AUCINS.0-4h and AUCGIR.0-4h
time frame: up to 4 hours
description: Compare the pharmacokinetic and pharmacodynamic effects of insulin lispro during the first 4 hours after s.c.
administration into either lipohypertrophic or normal adipose tissue during a euglycaemic clamp examination.
arm group label: Insulin lispro
arm group type: Experimental
intervention type: Drug
intervention name: Insulin LISPRO
arm group label: Insulin lispro
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Ulrike Hövelmann
role: Principal Investigator
affiliation: Profil Institut für Stoffwechselforschung GmbH
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin Lispro