<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/NCT02212951</url>
  </required_header>
  <id_info>
    <org_study_id>3-152</org_study_id>
    <nct_id>NCT02212951</nct_id>
  </id_info>
  <brief_title>Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500</brief_title>
  <official_title>A Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin R U-500 and Humalog Mix 75/25 in Subjects With Type 2 Diabetes Mellitus Who Are Treated With 50-200 Units of Insulin Per Day</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biodel</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biodel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is to compare meal time glucose control associated with BIOD-531, a rapidly&#xD;
      absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <primary_completion_date type="Actual">July 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-standardized meal glucose exposure (AUC)</measure>
    <time_frame>0-120 minutes after meal</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)</measure>
    <time_frame>0-720 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin exposure (AUC)</measure>
    <time_frame>Various time frames over 720 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal insulin concentration</measure>
    <time_frame>0-720 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post breakfast and post-lunch glucose exposure (AUC)</measure>
    <time_frame>Various times frames over 720 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-breakfast and post-lunch maximal glucose concentrations</measure>
    <time_frame>0-720 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Injection site toleration (VAS and severity scales)</measure>
    <time_frame>30 minutes post injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Draize injection site erythema and edema scoring</measure>
    <time_frame>0-720 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>BIOD-531 pre-meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Humalog Mix 75/25 pre-meal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Humulin R U-500</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BIOD-531 post-meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIOD-531</intervention_name>
    <arm_group_label>BIOD-531 post-meal</arm_group_label>
    <arm_group_label>BIOD-531 pre-meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Humalog Mix 75/25</intervention_name>
    <arm_group_label>Humalog Mix 75/25 pre-meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Humulin R U-500</intervention_name>
    <arm_group_label>Humulin R U-500</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65&#xD;
&#xD;
          -  BMI &gt; 25 kg/m2&#xD;
&#xD;
          -  Type 2 Diabetes Mellitus&#xD;
&#xD;
          -  HbA1c &lt; 10.0%&#xD;
&#xD;
          -  Subject uses 50-200 units of insulin/day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 Diabetes Mellitus&#xD;
&#xD;
          -  History of bariatric surgery&#xD;
&#xD;
          -  Corticosteroid therapy&#xD;
&#xD;
          -  Significant cardiovascular or other major organ disease&#xD;
&#xD;
          -  Females who are breast feeding or pregnant&#xD;
&#xD;
          -  A sexually active person not using adequate contraceptive methods&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Profil Institute for Clinical Research</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 7, 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>
  <disposition_first_submitted>January 15, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>January 15, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">February 8, 2016</disposition_first_posted>
  <last_update_submitted>January 15, 2016</last_update_submitted>
  <last_update_submitted_qc>January 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 8, 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>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>Insulin Lispro</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02212951
org study id: 3-152
nct id: NCT02212951
lead sponsor: 
has dmc: No
The study is to compare meal time glucose control associated with BIOD-531, a rapidly
      absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Post-standardized meal glucose exposure (AUC)
time frame: 0-120 minutes after meal
measure: Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)
time frame: 0-720 minutes
measure: Insulin exposure (AUC)
time frame: Various time frames over 720 minutes
measure: Maximal insulin concentration
time frame: 0-720 minutes
measure: Post breakfast and post-lunch glucose exposure (AUC)
time frame: Various times frames over 720 minutes
measure: Post-breakfast and post-lunch maximal glucose concentrations
time frame: 0-720 minutes
measure: Injection site toleration (VAS and severity scales)
time frame: 30 minutes post injection
measure: Draize injection site erythema and edema scoring
time frame: 0-720 minutes
arm group label: BIOD-531 pre-meal
arm group type: Experimental
description: Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast
arm group label: Humalog Mix 75/25 pre-meal
arm group type: Active Comparator
description: Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast
arm group label: Humulin R U-500
arm group type: Active Comparator
description: Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast
arm group label: BIOD-531 post-meal
arm group type: Experimental
description: Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast
intervention type: Drug
intervention name: BIOD-531
arm group label: BIOD-531 post-meal
arm group label: BIOD-531 pre-meal
intervention type: Drug
intervention name: Humalog Mix 75/25
arm group label: Humalog Mix 75/25 pre-meal
intervention type: Drug
intervention name: Humulin R U-500
arm group label: Humulin R U-500
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Lispro