<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/NCT03286751</url>
  </required_header>
  <id_info>
    <org_study_id>16898</org_study_id>
    <secondary_id>2017-001859-32</secondary_id>
    <secondary_id>I8B-MC-ITSH</secondary_id>
    <nct_id>NCT03286751</nct_id>
  </id_info>
  <brief_title>A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants</brief_title>
  <official_title>A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 and Humalog Across Different Subcutaneous Doses in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog).&#xD;
      Both drugs are given by injection under the skin of the abdomen. The study will be conducted&#xD;
      in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect&#xD;
      of different doses of LY900014 on blood sugar levels in comparison with insulin lispro. The&#xD;
      study will last about 7 to 12 weeks for each participant, including screening and follow up.&#xD;
      Screening is required within 28 days prior to entering the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2017</start_date>
  <completion_date type="Actual">February 6, 2018</completion_date>
  <primary_completion_date type="Actual">February 6, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)</measure>
    <time_frame>Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose</time_frame>
    <description>Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose [AUC(0-10h)]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucodynamics: Total Amount of Glucose Infused (Gtot)</measure>
    <time_frame>Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose</time_frame>
    <description>Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>LY900014</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin Lispro (Humalog)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY900014</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>LY900014</arm_group_label>
    <other_name>Ultra-Rapid Lispro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin Lispro</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Insulin Lispro (Humalog)</arm_group_label>
    <other_name>LY275585</other_name>
    <other_name>Humalog</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or a female (not pregnant and agreeable to take birth control measures&#xD;
             until one month after study completion)&#xD;
&#xD;
          -  Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)&#xD;
&#xD;
          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine&#xD;
             laboratory test results&#xD;
&#xD;
          -  Are nonsmokers, have not smoked for at least 6 months prior to entering the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are currently participating in or completed a clinical trial within the last 30 days&#xD;
&#xD;
          -  Have previously participated or withdrawn from this study&#xD;
&#xD;
          -  Have donated blood or have blood loss of more than 500 mL within the past 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.</name>
      <address>
        <city>Mainz</city>
        <zip>55116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.</name>
      <address>
        <city>Neuss</city>
        <zip>41460</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>April 20, 2020</results_first_submitted>
  <results_first_submitted_qc>April 20, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 1, 2020</results_first_posted>
  <last_update_submitted>April 20, 2020</last_update_submitted>
  <last_update_submitted_qc>April 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2020</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, 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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03286751/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03286751/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This was a 6-period crossover study in which participants received a single 7 Unit (U), 15 U, or 30 U subcutaneous (SC) dose of LY900014 or Humalog in one of six sequences. There was a washout period of ≥ 3 days between each euglycemic clamp procedure.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sequence 1: ABFCED</title>
          <description>Participants received a single SC dose in each treatment period.&#xD;
A = 7 U LY900014&#xD;
B = 15 U LY900014&#xD;
F = 30 U Humalog&#xD;
C = 30 U LY900014&#xD;
E = 15 U Humalog&#xD;
D = 7 U Humalog</description>
        </group>
        <group group_id="P2">
          <title>Sequence 2: BCADFE</title>
          <description>Participants received a single SC dose in each treatment period.&#xD;
B = 15 U LY900014&#xD;
C = 30 U LY900014&#xD;
A = 7 U LY900014&#xD;
D = 7 U Humalog&#xD;
F = 30 U Humalog&#xD;
E = 15 U Humalog</description>
        </group>
        <group group_id="P3">
          <title>Sequence 3: CDBEAF</title>
          <description>Participants received a single SC dose in each treatment period.&#xD;
C = 30 U LY900014&#xD;
D = 7 U Humalog&#xD;
B = 15 U LY900014&#xD;
E = 15 U Humalog&#xD;
A = 7 U LY900014&#xD;
F = 30 U Humalog</description>
        </group>
        <group group_id="P4">
          <title>Sequence 4: DECFBA</title>
          <description>Participants received a single SC dose in each treatment period.&#xD;
D = 7 U Humalog&#xD;
E = 15 U Humalog&#xD;
C = 30 U LY900014&#xD;
F = 30 U Humalog&#xD;
B = 15 U LY900014&#xD;
A = 7 U LY900014</description>
        </group>
        <group group_id="P5">
          <title>Sequence 5: EFDACB</title>
          <description>Participants received a single SC dose in each treatment period.&#xD;
E = 15 U Humalog&#xD;
F = 30 U Humalog&#xD;
D = 7 U Humalog&#xD;
A = 7 U LY900014&#xD;
C = 30 U LY900014&#xD;
B = 15 U LY900014</description>
        </group>
        <group group_id="P6">
          <title>Sequence 6: FAEBDC</title>
          <description>Participants received a single SC dose in each treatment period.&#xD;
F = 30 U Humalog&#xD;
A = 7 U LY900014&#xD;
E = 15 U Humalog&#xD;
B = 15 U LY900014&#xD;
D = 7 U Humalog&#xD;
C = 30 U LY900014</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Personal Reasons</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 4</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period 4</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 5</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period 5</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 6</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All Participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Overall</title>
          <description>All participants who received at least on dose of study drug.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.9" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)</title>
        <description>Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose [AUC(0-10h)]</description>
        <time_frame>Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose</time_frame>
        <population>All participants who received at least one dose of study drug and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>7 U Humalog</title>
            <description>Single SC dose 7 U Humalog.</description>
          </group>
          <group group_id="O2">
            <title>7 U LY900014</title>
            <description>Single SC dose 7 U LY900014.</description>
          </group>
          <group group_id="O3">
            <title>15 U Humalog</title>
            <description>Single SC dose 15 U Humalog.</description>
          </group>
          <group group_id="O4">
            <title>15 U LY900014</title>
            <description>Single SC dose 15 U LY900014.</description>
          </group>
          <group group_id="O5">
            <title>30 U Humalog</title>
            <description>Single SC dose 30 U Humalog.</description>
          </group>
          <group group_id="O6">
            <title>30 U LY900014</title>
            <description>Single SC dose 30 U LY900014.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)</title>
          <description>Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose [AUC(0-10h)]</description>
          <population>All participants who received at least one dose of study drug and had evaluable PK data.</population>
          <units>picomole * hour per liter(pmol*/L)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="41"/>
                <count group_id="O4" value="40"/>
                <count group_id="O5" value="40"/>
                <count group_id="O6" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="649" spread="16"/>
                    <measurement group_id="O2" value="656" spread="17"/>
                    <measurement group_id="O3" value="1400" spread="19"/>
                    <measurement group_id="O4" value="1450" spread="17"/>
                    <measurement group_id="O5" value="3050" spread="18"/>
                    <measurement group_id="O6" value="3180" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5495</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Ratio of Geometric LSMeans</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.974</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2236</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Ratio of Geometric LSMeans</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.986</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0727</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Ratio of Geometric LSMeans</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.997</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucodynamics: Total Amount of Glucose Infused (Gtot)</title>
        <description>Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp</description>
        <time_frame>Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose</time_frame>
        <population>All participants who received at least one dose of study drug and completed at least one clamp procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>7 U Humalog</title>
            <description>Single SC dose 7 U Humalog.</description>
          </group>
          <group group_id="O2">
            <title>7 U LY900014</title>
            <description>Single SC dose 7 U LY900014.</description>
          </group>
          <group group_id="O3">
            <title>15 U Humalog</title>
            <description>Single SC dose 15 U Humalog.</description>
          </group>
          <group group_id="O4">
            <title>15 U LY900014</title>
            <description>Single SC dose 15 U LY900014.</description>
          </group>
          <group group_id="O5">
            <title>30 U Humalog</title>
            <description>Single SC dose 30 U Humalog.</description>
          </group>
          <group group_id="O6">
            <title>30 U LY900014</title>
            <description>Single SC dose 30 U LY900014.</description>
          </group>
        </group_list>
        <measure>
          <title>Glucodynamics: Total Amount of Glucose Infused (Gtot)</title>
          <description>Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp</description>
          <population>All participants who received at least one dose of study drug and completed at least one clamp procedure.</population>
          <units>milligrams per kilogram (mg/kg)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="41"/>
                <count group_id="O4" value="40"/>
                <count group_id="O5" value="40"/>
                <count group_id="O6" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1120" spread="53"/>
                    <measurement group_id="O2" value="1080" spread="60"/>
                    <measurement group_id="O3" value="1970" spread="44"/>
                    <measurement group_id="O4" value="1860" spread="45"/>
                    <measurement group_id="O5" value="3290" spread="32"/>
                    <measurement group_id="O6" value="3030" spread="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5749</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Ratio of Geometric LSMeans</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1578</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Ratio of Geometric LSMeans</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1351</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Ratio of Geometric LSMeans</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to study completion (up to 12 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>7 U LY900014</title>
          <description>Single SC dose 7 U LY900014.</description>
        </group>
        <group group_id="E2">
          <title>15 U LY900014</title>
          <description>Single SC dose 15 U LY900014.</description>
        </group>
        <group group_id="E3">
          <title>30 U LY900014</title>
          <description>Single SC dose 30 U LY900014.</description>
        </group>
        <group group_id="E4">
          <title>7 U Humalog</title>
          <description>Single SC dose 7 U Humalog.</description>
        </group>
        <group group_id="E5">
          <title>15 U Humalog</title>
          <description>Single SC dose 15 U Humalog.</description>
        </group>
        <group group_id="E6">
          <title>30 U Humalog</title>
          <description>Single SC dose 15 U Humalog.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="41"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="40"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="41"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="41"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="40"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
      <email>Clinicaltrials.gov@lilly.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03286751
org study id: 16898
secondary id: 2017-001859-32
secondary id: I8B-MC-ITSH
nct id: NCT03286751
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog).
      Both drugs are given by injection under the skin of the abdomen. The study will be conducted
      in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect
      of different doses of LY900014 on blood sugar levels in comparison with insulin lispro. The
      study will last about 7 to 12 weeks for each participant, including screening and follow up.
      Screening is required within 28 days prior to entering the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)
time frame: Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose
description: Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose [AUC(0-10h)]
measure: Glucodynamics: Total Amount of Glucose Infused (Gtot)
time frame: Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose
description: Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
arm group label: LY900014
arm group type: Experimental
description: Single dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods.
arm group label: Insulin Lispro (Humalog)
arm group type: Active Comparator
description: Single dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six periods.
intervention type: Drug
intervention name: LY900014
description: Administered SC
arm group label: LY900014
other name: Ultra-Rapid Lispro
intervention type: Drug
intervention name: Insulin Lispro
description: Administered SC
arm group label: Insulin Lispro (Humalog)
other name: LY275585
other name: Humalog
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Lispro
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 