<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/NCT03765502</url>
  </required_header>
  <id_info>
    <org_study_id>17156</org_study_id>
    <secondary_id>I8R-MC-IGBM</secondary_id>
    <nct_id>NCT03765502</nct_id>
  </id_info>
  <brief_title>A Study Comparing User Experience of Different Delivery Devices for Glucagon</brief_title>
  <official_title>A Simulation Study Comparing Successful Administration, Time to Administer, and User Experience of Ready-to-Use Nasal Glucagon With Reconstitutable Injectable Glucagon</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>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to learn more about different devices for delivering glucagon&#xD;
      during simulations of severe hypoglycemic (low blood sugar) emergencies. The study will be&#xD;
      carried out using medical manikins to simulate real life scenarios. No drug will be&#xD;
      administered to humans. Part A will last approximately 17 days for Trained Users and&#xD;
      Participants with Diabetes (PWD). Part B will last approximately nine (9) days for Untrained&#xD;
      Users. Each part will be separated by approximately 7 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Actual">January 3, 2019</completion_date>
  <primary_completion_date type="Actual">January 3, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Trained Users That Performed a Successful Administration for Each Device</measure>
    <time_frame>Part A: Days 8 - 9 and Days 15 - 17</time_frame>
    <description>Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Untrained Users That Perform a Successful Administration for Each Device</measure>
    <time_frame>Part B: Day 1 and Days 8-9</time_frame>
    <description>Percentage of untrained users who found both devices and performed a successful administration of both rescue devices for both simulations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Time for Trained Users to Successfully Administer One Device Over the Other</measure>
    <time_frame>Part A: Day 8 and Days 15-17</time_frame>
    <description>Average time for trained users who found both devices to successfully administer one rescue device over the other in Part A.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Time for Untrained Users to Successfully Administer One Device Over the Other</measure>
    <time_frame>Part B: Day 1 and Days 8-9</time_frame>
    <description>Average time for untrained users who found both devices to successfully administer one rescue device over the other in Part B. To successfully administer either NG or GEK, a participant must complete all of the critical steps for each device, and administer a complete dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other</measure>
    <time_frame>Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9</time_frame>
    <description>Overall preference was measured via the Rescue Device Preference (RDP) questionnaire completed by Trained and Untrained participant users. Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK. Data here represents pooling for Part A and Part B.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants (PWD) That Prefer One Device Over the Other</measure>
    <time_frame>Part A: Days 15 - 17</time_frame>
    <description>Preference was measured by the PWD overall feeling of being safer during a severe low blood sugar event using Rescue Device Preference-Associated Person (RDP-AP). Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other</measure>
    <time_frame>Part A: Days 15 -17 and Part B: Days 8 - 9</time_frame>
    <description>Ease of use was measured via the Individual Rescue Device Ease of Use (RDEU) Questionnaire by Trained and Untrained Participants. Participants answered three questions about ease of use for each device by choosing one of five radio buttons: Strongly disagree, disagree, neither disagree nor agree, agree, strongly agree. Data here represents pooling of Simulation 1 for Part A and Part B.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Nasal Glucagon Device (NG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Empty NG device administered to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucagon Emergency Kit (GEK)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Commercially available GEK delivered intramuscularly to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal Glucagon Device (NG)</intervention_name>
    <description>NG devices will be provided empty of drug product</description>
    <arm_group_label>Nasal Glucagon Device (NG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GEK</intervention_name>
    <description>Used to administer glucagon intramuscularly (IM)</description>
    <arm_group_label>Glucagon Emergency Kit (GEK)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IM Glucagon</intervention_name>
    <description>Administered IM via GEK</description>
    <arm_group_label>Glucagon Emergency Kit (GEK)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All participants (Trained Users, Participants with Diabetes [PWDs] and Untrained Users):&#xD;
&#xD;
          -  Are able to understand the purpose and procedure of the study and to give written&#xD;
             informed consent to show willingness to participate in the study&#xD;
&#xD;
        Trained Users only:&#xD;
&#xD;
          -  Are participants who are not diagnosed with Type 1 Diabetes Mellitus (T1DM) or Type 2&#xD;
             Diabetes Mellitus (T2DM)&#xD;
&#xD;
          -  Are close friends/relatives of a patient with T1DM or T2DM on insulin&#xD;
&#xD;
          -  Have not previously administered any rescue medications (e.g. epinephrine, glucagon,&#xD;
             narcan or seizure medications)&#xD;
&#xD;
        Untrained Users only:&#xD;
&#xD;
          -  Have not been diagnosed with T1DM or T2DM, and are not a Trained User of a person with&#xD;
             T1DM or T2DM&#xD;
&#xD;
          -  Have not previously administered any rescue medications (e.g. epinephrine, glucagon,&#xD;
             narcan or seizure medications)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All participants (Trained Users, PWDs and Untrained Users):&#xD;
&#xD;
          -  In the opinion of the investigator or sponsor, are unsuitable for inclusion in the&#xD;
             study&#xD;
&#xD;
        Trained Users and Untrained Users only (i.e. the participants involved in the simulations):&#xD;
&#xD;
          -  Are currently enrolled in a clinical study involving any type of medical research&#xD;
             judged not to be scientifically or medically compatible with this study&#xD;
&#xD;
          -  Are judged by the investigator as being likely to have difficulty performing the&#xD;
             administration due to physical, cognitive and/or severe psychiatric disorder&#xD;
&#xD;
          -  Are judged by the investigator as being trained or experienced in performing rescue&#xD;
             drug administration&#xD;
&#xD;
          -  Are judged by the investigator as being trained or experienced in performing&#xD;
             high-fidelity simulations of drug administration&#xD;
&#xD;
          -  Have received formal training in a medical field, and/or worked in this field within&#xD;
             the prior 5 years; or otherwise are judged by the investigator as being trained or&#xD;
             experienced as a first responder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>High Point Clinical Trials Center</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <results_first_submitted>January 6, 2020</results_first_submitted>
  <results_first_submitted_qc>March 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 20, 2020</results_first_posted>
  <last_update_submitted>March 6, 2020</last_update_submitted>
  <last_update_submitted_qc>March 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucagon</mesh_term>
    <mesh_term>Glucagon-Like Peptide 1</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>November 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03765502/SAP_000.pdf</document_url>
    </provided_document>
    <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>December 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03765502/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Trained Users were recruited alongside a participant with diabetes (PWD) with whom they were familiar. They were given a level of training intended to mimic that of a real-life caregiver on both devices: glucagon emergency kit (GEK) and nasal glucagon (NG). Untrained Users who have limited knowledge of severe hypoglycemia did not receive training.</recruitment_details>
      <pre_assignment_details>Trained users participated in Part A and untrained users participated in Part B.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part A Trained Users NG/GEK</title>
          <description>Simulation 1: Day 8 participants were trained to administer an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency.&#xD;
Simulation 2: Day 15 participants were trained to administer a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency.&#xD;
No drug was administered to humans in either simulation.</description>
        </group>
        <group group_id="P2">
          <title>Part A Trained Users GEK/NG</title>
          <description>Simulation 1: Day 8 participants were trained to administer a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency.&#xD;
Simulation 2: Day 15 participants were trained to administer an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency.&#xD;
No drug was administered to humans in either simulation.</description>
        </group>
        <group group_id="P3">
          <title>Part A Person With Diabetes (PWD)</title>
          <description>Day 1 - PWD trained participants to administer a glucose emergency kit intramuscularly or an empty nasal glucagon device (depending on randomization).&#xD;
Simulation 1: Day 8 - PWD trained participants to administer an empty nasal glucagon device or a glucose emergency kit intramuscularly(depending on randomization).&#xD;
No drug was administered to humans in either simulation.</description>
        </group>
        <group group_id="P4">
          <title>Part B Untrained Users NG/GEK</title>
          <description>Simulation1: Day 1 untrained participants administered an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency.&#xD;
Simulations 2: Day 8 untrained participants administered a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency.&#xD;
No drug was administered to humans in either simulation.</description>
        </group>
        <group group_id="P5">
          <title>Part B Untrained Users GEK/NG</title>
          <description>Simulation 1: Day 1 untrained participants administered a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency.&#xD;
Simulation 2: Day 8 untrained participants administered an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency.&#xD;
No drug was administered to humans in either simulation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Simulation 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="33"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="33"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="17"/>
              </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_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Simulation 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="12">Participant completed Period 1 GEK simulation but did not return for the Period 2 NG simulation.</participants>
                <participants group_id="P3" count="32">PWD completed Period 1 GEK simulation but did not return for the Period 2 NG simulation.</participants>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="32"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="17"/>
              </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_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized trained user participants, untrained user participants, and participants with diabetes.</population>
      <group_list>
        <group group_id="B1">
          <title>Part A Trained Users</title>
          <description>All trained participants in Part A</description>
        </group>
        <group group_id="B2">
          <title>Part A Participants With Diabetes</title>
          <description>All participants with diabetes in Part A</description>
        </group>
        <group group_id="B3">
          <title>Part B Untrained Users</title>
          <description>All participants in Part B.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="33"/>
            <count group_id="B4" value="99"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                  </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="23"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="39"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Trained Users That Performed a Successful Administration for Each Device</title>
        <description>Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.</description>
        <time_frame>Part A: Days 8 - 9 and Days 15 - 17</time_frame>
        <population>All trained user participants who found both devices and participated in at least one simulation of a rescue device. Participants with diabetes (PWD) reporting group data not collected per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Nasal Glucagon (NG)</title>
            <description>Trained participants who found and had a successful administration of NG rescue device.</description>
          </group>
          <group group_id="O2">
            <title>Glucagon Emergency Kit (GEK)</title>
            <description>Trained participants who found had a successful administration of the GEK rescue device.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Trained Users That Performed a Successful Administration for Each Device</title>
          <description>Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.</description>
          <population>All trained user participants who found both devices and participated in at least one simulation of a rescue device. Participants with diabetes (PWD) reporting group data not collected per protocol.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.3"/>
                    <measurement group_id="O2" value="15.6"/>
                  </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>&lt;.0001</p_value>
            <method>McNemar</method>
            <method_desc>Crossover design: paired test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Untrained Users That Perform a Successful Administration for Each Device</title>
        <description>Percentage of untrained users who found both devices and performed a successful administration of both rescue devices for both simulations.</description>
        <time_frame>Part B: Day 1 and Days 8-9</time_frame>
        <population>All untrained user participants who found both devices and participated in at least one simulation of a rescue device.</population>
        <group_list>
          <group group_id="O1">
            <title>Nasal Glucagon (NG)</title>
            <description>Participants who were not trained on the administration of NG rescue device.</description>
          </group>
          <group group_id="O2">
            <title>Glucagon Emergency Kit (GEK)</title>
            <description>Participants who were not trained on the administration of the GEK.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Untrained Users That Perform a Successful Administration for Each Device</title>
          <description>Percentage of untrained users who found both devices and performed a successful administration of both rescue devices for both simulations.</description>
          <population>All untrained user participants who found both devices and participated in at least one simulation of a rescue device.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9"/>
                    <measurement group_id="O2" value="0"/>
                  </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>&lt;.0001</p_value>
            <method>McNemar</method>
            <method_desc>Crossover design: paired test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Time for Trained Users to Successfully Administer One Device Over the Other</title>
        <description>Average time for trained users who found both devices to successfully administer one rescue device over the other in Part A.</description>
        <time_frame>Part A: Day 8 and Days 15-17</time_frame>
        <population>All trained user participants who found both devices and completed at least one device simulation. PWD reporting group data not collected per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Nasal Glucagon (NG)</title>
            <description>Trained participants who found device and had a successful administration of NG rescue device.</description>
          </group>
          <group group_id="O2">
            <title>Glucagon Emergency Kit (GEK)</title>
            <description>Trained participants who found device and had a successful administration of GEK rescue device.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Time for Trained Users to Successfully Administer One Device Over the Other</title>
          <description>Average time for trained users who found both devices to successfully administer one rescue device over the other in Part A.</description>
          <population>All trained user participants who found both devices and completed at least one device simulation. PWD reporting group data not collected per protocol.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.3" spread="52.0"/>
                    <measurement group_id="O2" value="81.8" spread="18.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Time for Untrained Users to Successfully Administer One Device Over the Other</title>
        <description>Average time for untrained users who found both devices to successfully administer one rescue device over the other in Part B. To successfully administer either NG or GEK, a participant must complete all of the critical steps for each device, and administer a complete dose.</description>
        <time_frame>Part B: Day 1 and Days 8-9</time_frame>
        <population>All untrained user participants who found both devices and completed at least one successful rescue device simulation.</population>
        <group_list>
          <group group_id="O1">
            <title>Nasal Glucagon Device (NG)</title>
            <description>Untrained participants who found device and had a successful administration of NG rescue device.</description>
          </group>
          <group group_id="O2">
            <title>Glucagon Emergency Kit (GEK)</title>
            <description>Untrained participants who found device and had a successful administration of GEK rescue device.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Time for Untrained Users to Successfully Administer One Device Over the Other</title>
          <description>Average time for untrained users who found both devices to successfully administer one rescue device over the other in Part B. To successfully administer either NG or GEK, a participant must complete all of the critical steps for each device, and administer a complete dose.</description>
          <population>All untrained user participants who found both devices and completed at least one successful rescue device simulation.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.5" spread="47.8"/>
                    <measurement group_id="O2" value="NA" spread="NA">There were no successful administrations of the Glucagon Emergency Kit for the untrained participants. Data for average time of unsuccessful administrations were not collected.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other</title>
        <description>Overall preference was measured via the Rescue Device Preference (RDP) questionnaire completed by Trained and Untrained participant users. Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK. Data here represents pooling for Part A and Part B.</description>
        <time_frame>Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9</time_frame>
        <population>All trained and untrained participants who found both devices and completed the rescue device preference questionnaire for Part A and Part B combined. PWD reporting group data not collected per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A (Trained)</title>
            <description>Overall preference for Trained users (Part A) for rescue device, NG and GEK.</description>
          </group>
          <group group_id="O2">
            <title>Part B (Untrained)</title>
            <description>Overall preference for Untrained users (Part B) for rescue device, NG and GEK.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other</title>
          <description>Overall preference was measured via the Rescue Device Preference (RDP) questionnaire completed by Trained and Untrained participant users. Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK. Data here represents pooling for Part A and Part B.</description>
          <population>All trained and untrained participants who found both devices and completed the rescue device preference questionnaire for Part A and Part B combined. PWD reporting group data not collected per protocol.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strongly Prefer Nasal Glucagon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.1"/>
                    <measurement group_id="O2" value="71.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer Nasal Glucagon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6"/>
                    <measurement group_id="O2" value="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5"/>
                    <measurement group_id="O2" value="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer Injectable Glucagon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strongly Prefer Injectable Glucagon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5"/>
                    <measurement group_id="O2" value="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants (PWD) That Prefer One Device Over the Other</title>
        <description>Preference was measured by the PWD overall feeling of being safer during a severe low blood sugar event using Rescue Device Preference-Associated Person (RDP-AP). Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK.</description>
        <time_frame>Part A: Days 15 - 17</time_frame>
        <population>All PWD who completed the device preference questionnaire.</population>
        <group_list>
          <group group_id="O1">
            <title>Participant With Diabetes (PWD)</title>
            <description>Preference was measured by the PWD overall feeling of being safer during a severe low blood sugar event using Rescue Device Preference-Associated Person (RDP-AP). Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants (PWD) That Prefer One Device Over the Other</title>
          <description>Preference was measured by the PWD overall feeling of being safer during a severe low blood sugar event using Rescue Device Preference-Associated Person (RDP-AP). Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK.</description>
          <population>All PWD who completed the device preference questionnaire.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strongly Prefer Nasal Glucagon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer Nasal Glucagon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer Injectable Glucagon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strongly Prefer Injectable Glucagon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other</title>
        <description>Ease of use was measured via the Individual Rescue Device Ease of Use (RDEU) Questionnaire by Trained and Untrained Participants. Participants answered three questions about ease of use for each device by choosing one of five radio buttons: Strongly disagree, disagree, neither disagree nor agree, agree, strongly agree. Data here represents pooling of Simulation 1 for Part A and Part B.</description>
        <time_frame>Part A: Days 15 -17 and Part B: Days 8 - 9</time_frame>
        <population>All trained and untrained users who found both devices and completed the device preference questionnaires. PWD reporting group data not collected per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A (Trained)</title>
            <description>Overall ease of use for Trained users (Part A) for rescue device, NG and GEK.</description>
          </group>
          <group group_id="O2">
            <title>Part B (Untrained)</title>
            <description>Overall ease of use for Untrained users (Part B) for rescue device, NG and GEK.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other</title>
          <description>Ease of use was measured via the Individual Rescue Device Ease of Use (RDEU) Questionnaire by Trained and Untrained Participants. Participants answered three questions about ease of use for each device by choosing one of five radio buttons: Strongly disagree, disagree, neither disagree nor agree, agree, strongly agree. Data here represents pooling of Simulation 1 for Part A and Part B.</description>
          <population>All trained and untrained users who found both devices and completed the device preference questionnaires. PWD reporting group data not collected per protocol.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strongly Prefer Nasal Glucagon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.4"/>
                    <measurement group_id="O2" value="80.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer Nasal Glucagon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0"/>
                    <measurement group_id="O2" value="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer Injectable Glucagon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strongly Prefer Injectable Glucagon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2"/>
                    <measurement group_id="O2" value="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to end of study (up to 17 days)</time_frame>
      <desc>All participants who participated in at least one training or simulation of a study device.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part A Trained Users Nasal Glucagon (NG)</title>
          <description>Trained users NG.</description>
        </group>
        <group group_id="E2">
          <title>Part A Trained Users Glucagon Emergency Kit (GEK)</title>
          <description>Trained user GEK.</description>
        </group>
        <group group_id="E3">
          <title>Part A Participants With Diabetes (PWD)</title>
          <description>PWD</description>
        </group>
        <group group_id="E4">
          <title>Part B Untrained Users NG</title>
          <description>Untrained user NG.</description>
        </group>
        <group group_id="E5">
          <title>Part B Untrained Users GEK</title>
          <description>Untrained user GEK.</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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
              </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 sponsor can review results communications prior to public release and can embargo communications regarding study results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The agreement also provides that if CRU is unwilling to delay the publication or presentation, CRU will remove the information which sponsor has specified it reasonably believes would jeopardize its intellectual property interests.</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/NCT03765502
org study id: 17156
secondary id: I8R-MC-IGBM
nct id: NCT03765502
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The purpose of the study is to learn more about different devices for delivering glucagon
      during simulations of severe hypoglycemic (low blood sugar) emergencies. The study will be
      carried out using medical manikins to simulate real life scenarios. No drug will be
      administered to humans. Part A will last approximately 17 days for Trained Users and
      Participants with Diabetes (PWD). Part B will last approximately nine (9) days for Untrained
      Users. Each part will be separated by approximately 7 days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Percentage of Trained Users That Performed a Successful Administration for Each Device
time frame: Part A: Days 8 - 9 and Days 15 - 17
description: Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.
measure: Percentage of Untrained Users That Perform a Successful Administration for Each Device
time frame: Part B: Day 1 and Days 8-9
description: Percentage of untrained users who found both devices and performed a successful administration of both rescue devices for both simulations.
measure: Average Time for Trained Users to Successfully Administer One Device Over the Other
time frame: Part A: Day 8 and Days 15-17
description: Average time for trained users who found both devices to successfully administer one rescue device over the other in Part A.
measure: Average Time for Untrained Users to Successfully Administer One Device Over the Other
time frame: Part B: Day 1 and Days 8-9
description: Average time for untrained users who found both devices to successfully administer one rescue device over the other in Part B. To successfully administer either NG or GEK, a participant must complete all of the critical steps for each device, and administer a complete dose.
measure: Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other
time frame: Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9
description: Overall preference was measured via the Rescue Device Preference (RDP) questionnaire completed by Trained and Untrained participant users. Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK. Data here represents pooling for Part A and Part B.
measure: Percentage of Participants (PWD) That Prefer One Device Over the Other
time frame: Part A: Days 15 - 17
description: Preference was measured by the PWD overall feeling of being safer during a severe low blood sugar event using Rescue Device Preference-Associated Person (RDP-AP). Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK.
measure: Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other
time frame: Part A: Days 15 -17 and Part B: Days 8 - 9
description: Ease of use was measured via the Individual Rescue Device Ease of Use (RDEU) Questionnaire by Trained and Untrained Participants. Participants answered three questions about ease of use for each device by choosing one of five radio buttons: Strongly disagree, disagree, neither disagree nor agree, agree, strongly agree. Data here represents pooling of Simulation 1 for Part A and Part B.
arm group label: Nasal Glucagon Device (NG)
arm group type: Experimental
description: Empty NG device administered to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.
arm group label: Glucagon Emergency Kit (GEK)
arm group type: Active Comparator
description: Commercially available GEK delivered intramuscularly to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.
intervention type: Device
intervention name: Nasal Glucagon Device (NG)
description: NG devices will be provided empty of drug product
arm group label: Nasal Glucagon Device (NG)
intervention type: Device
intervention name: GEK
description: Used to administer glucagon intramuscularly (IM)
arm group label: Glucagon Emergency Kit (GEK)
intervention type: Drug
intervention name: IM Glucagon
description: Administered IM via GEK
arm group label: Glucagon Emergency Kit (GEK)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
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: 
country: United States
responsible party type: Sponsor
mesh term: Glucagon
mesh term: Glucagon-Like Peptide 1
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 