<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/NCT02213146</url>
  </required_header>
  <id_info>
    <org_study_id>BC3-CT010</org_study_id>
    <nct_id>NCT02213146</nct_id>
  </id_info>
  <brief_title>A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes</brief_title>
  <official_title>A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adocia</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Adocia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The addition of BioChaperone to already marketed prandial human insulin preparations may&#xD;
      accelerate the onset and shorten the duration of action due to facilitation of the insulin&#xD;
      absorption after subcutaneous injection.&#xD;
&#xD;
      The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in&#xD;
      subjects with type 1 diabetes under a dose of 0.2 U/kg.&#xD;
&#xD;
      This trial is a single center, randomised, double-blinded, three treatment, three-period&#xD;
      cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each&#xD;
      subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a&#xD;
      single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3&#xD;
      separate dosing visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the curve (AUCins(0-1h))</measure>
    <time_frame>1 hour</time_frame>
    <description>Area under the human insulin serum concentration - time curve from t=0 to 1 hour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Early t0.5max ins/lisp</measure>
    <time_frame>up to 10 hours post administration</time_frame>
    <description>Time to first observed half maximum serum human insulin / insulin lispro concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours</measure>
    <time_frame>10 hours</time_frame>
    <description>Area under the glucose infusion rate - time curve from t=0 to 10 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax)</measure>
    <time_frame>10 hours</time_frame>
    <description>Time to first observed half maximum glucose infusion rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucodynamics: GIRmax - Maximum glucose infusion rate</measure>
    <time_frame>10 hours</time_frame>
    <description>Maximum glucose infusion rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration</measure>
    <time_frame>10 hours</time_frame>
    <description>Area under the human insulin / insulin lispro serum concentration - Time curve from t=0 to 10 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Tmax(ins/lisp) - Time to maximum observed serum human insulin concentration and insulin lispro concentration</measure>
    <time_frame>10 hours</time_frame>
    <description>Time to maximum observed serum human insulin concentration and insulin lispro concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters</measure>
    <time_frame>up to 7 weeks</time_frame>
    <description>Adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Cmax(ins/lisp)</measure>
    <time_frame>up to 10 hours</time_frame>
    <description>Maximum observed human insulin / insulin lispro serum concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours</measure>
    <time_frame>2 hours post administration</time_frame>
    <description>Area under the glucose infusion rate - time curve from t=0 to 2 hours</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Diabetes Mellitus Type 1</condition>
  <arm_group>
    <arm_group_label>BioChaperone human insulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BioChaperone Human Insulin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Human insulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Huminsulin® Normal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin lispro</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Humalog®</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BioChaperone human insulin</intervention_name>
    <description>Single dose of 0.2 U/kg body weight injected subcutaneously</description>
    <arm_group_label>BioChaperone human insulin</arm_group_label>
    <arm_group_label>Human insulin</arm_group_label>
    <arm_group_label>Insulin lispro</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Huminsulin® Normal</intervention_name>
    <description>Single dose of 0.2 U/kg body weight injected subcutaneously</description>
    <arm_group_label>BioChaperone human insulin</arm_group_label>
    <arm_group_label>Human insulin</arm_group_label>
    <arm_group_label>Insulin lispro</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Humalog®</intervention_name>
    <description>Single dose of 0.2 U/kg body weight injected subcutaneously</description>
    <arm_group_label>BioChaperone human insulin</arm_group_label>
    <arm_group_label>Human insulin</arm_group_label>
    <arm_group_label>Insulin lispro</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male subject with type 1 diabetes for at least 12 months&#xD;
&#xD;
          -  Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12&#xD;
             months&#xD;
&#xD;
          -  Body mass index: 18.5-28.0 kg BW·m-2&#xD;
&#xD;
          -  HbA1c: ≤ 9.0%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus type 2&#xD;
&#xD;
          -  Receipt of any investigational product within 3 months prior to first dosing of&#xD;
             investigational product in this trial&#xD;
&#xD;
          -  Clinically significant abnormalities as judged by the Investigator&#xD;
&#xD;
          -  Any systemic treatment with drugs known to interfere with glucose metabolism&#xD;
&#xD;
          -  History of alcoholism or drug/chemical abuse as per Investigator's judgement&#xD;
&#xD;
          -  Use of any tobacco or nicotine-contained product within one year prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grit Andersen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Profil GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Profil GmbH</name>
      <address>
        <city>Neuss</city>
        <zip>41460</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>May 31, 2017</last_update_submitted>
  <last_update_submitted_qc>May 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2017</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</mesh_term>
    <mesh_term>Insulin Lispro</mesh_term>
    <mesh_term>Insulin, Globin Zinc</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/NCT02213146
org study id: BC3-CT010
nct id: NCT02213146
lead sponsor: 
has dmc: No
The addition of BioChaperone to already marketed prandial human insulin preparations may
      accelerate the onset and shorten the duration of action due to facilitation of the insulin
      absorption after subcutaneous injection.

      The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in
      subjects with type 1 diabetes under a dose of 0.2 U/kg.

      This trial is a single center, randomised, double-blinded, three treatment, three-period
      cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each
      subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a
      single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3
      separate dosing visits.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Area under the curve (AUCins(0-1h))
time frame: 1 hour
description: Area under the human insulin serum concentration - time curve from t=0 to 1 hour
measure: Pharmacokinetics: Early t0.5max ins/lisp
time frame: up to 10 hours post administration
description: Time to first observed half maximum serum human insulin / insulin lispro concentration
measure: Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours
time frame: 10 hours
description: Area under the glucose infusion rate - time curve from t=0 to 10 hours
measure: Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax)
time frame: 10 hours
description: Time to first observed half maximum glucose infusion rate
measure: Glucodynamics: GIRmax - Maximum glucose infusion rate
time frame: 10 hours
description: Maximum glucose infusion rate
measure: Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration
time frame: 10 hours
description: Area under the human insulin / insulin lispro serum concentration - Time curve from t=0 to 10 hours
measure: Pharmacokinetics: Tmax(ins/lisp) - Time to maximum observed serum human insulin concentration and insulin lispro concentration
time frame: 10 hours
description: Time to maximum observed serum human insulin concentration and insulin lispro concentration
measure: Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
time frame: up to 7 weeks
description: Adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
measure: Pharmacokinetics: Cmax(ins/lisp)
time frame: up to 10 hours
description: Maximum observed human insulin / insulin lispro serum concentration
measure: Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours
time frame: 2 hours post administration
description: Area under the glucose infusion rate - time curve from t=0 to 2 hours
arm group label: BioChaperone human insulin
arm group type: Experimental
description: BioChaperone Human Insulin
arm group label: Human insulin
arm group type: Active Comparator
description: Huminsulin® Normal
arm group label: Insulin lispro
arm group type: Active Comparator
description: Humalog®
intervention type: Drug
intervention name: BioChaperone human insulin
description: Single dose of 0.2 U/kg body weight injected subcutaneously
arm group label: BioChaperone human insulin
arm group label: Human insulin
arm group label: Insulin lispro
intervention type: Drug
intervention name: Huminsulin® Normal
description: Single dose of 0.2 U/kg body weight injected subcutaneously
arm group label: BioChaperone human insulin
arm group label: Human insulin
arm group label: Insulin lispro
intervention type: Drug
intervention name: Humalog®
description: Single dose of 0.2 U/kg body weight injected subcutaneously
arm group label: BioChaperone human insulin
arm group label: Human insulin
arm group label: Insulin lispro
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Grit Andersen, MD
role: Principal Investigator
affiliation: Profil GmbH
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin Lispro
mesh term: Insulin, Globin Zinc