<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/NCT03307512</url>
  </required_header>
  <id_info>
    <org_study_id>Samba-AC</org_study_id>
    <nct_id>NCT03307512</nct_id>
  </id_info>
  <brief_title>PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD</brief_title>
  <official_title>Samba-AC: A Randomized, Open-Label, Cross-Over Study to Investigate the PK and PD Profiles of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Healthy Subjects and Non-Diabetic Subjects With Mild to Moderate Asthma or COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dance Biopharm Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>WCCT Global</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Dance Biopharm Inc.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a randomized, open-label, active-controlled, single dose crossover study with&#xD;
      either three or four treatment periods. Investigational treatment is with Dance 501 Human&#xD;
      Insulin Inhalation Solution (Dance 501) and the comparator is Insulin Lispro (Humalog®).&#xD;
&#xD;
      Target population will be Non-Diabetic individuals with mild to moderate asthma or chronic&#xD;
      obstructive pulmonary disease (COPD) and non-diabetic individuals without underlying lung&#xD;
      disease (healthy subjects).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The PK and PD profile of Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be&#xD;
      compared to subcutaneous injection of insulin lispro.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Termination due to incomplete enrollment; planned data analysis not performed&#xD;
  </why_stopped>
  <start_date type="Actual">February 6, 2018</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized, open-label, cross-over design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the insulin curve (AUC)</measure>
    <time_frame>10 hours</time_frame>
    <description>Area under the insulin curve (AUC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the glucose infusion rate curve (GIR)</measure>
    <time_frame>10 hours</time_frame>
    <description>Area under the glucose infusion rate curve (GIR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the insulin curve following inhalation of salbutamol</measure>
    <time_frame>10 hours</time_frame>
    <description>Area under the insulin curve following inhalation of salbutamol in subjects with asthma</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Safety and Tolerability</condition>
  <arm_group>
    <arm_group_label>Dance 501</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin Lispro</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Insulin Lispro (Humalog®) will be administered by subcutaneous injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>inhaled human insulin</intervention_name>
    <description>Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation</description>
    <arm_group_label>Dance 501</arm_group_label>
    <other_name>Dance 501</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin Lispro (Humalog U-100)</intervention_name>
    <description>Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection</description>
    <arm_group_label>Insulin Lispro</arm_group_label>
    <other_name>Lispro</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-diabetic subjects with asthma, or COPD. Non-smokers or smokers quit at least 6&#xD;
             months prior to enrollment. BMI &lt;= 35 kg/m2. Fasting blood glucose &lt;= 125 mg/dL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pulmonary disorder other than asthma or COPD. Upper respiratory within previous 4&#xD;
             weeks. Significant exacerbation of asthma or COPD symptoms. Hospitalization for asthma&#xD;
             or COPD within previous 3 months. Clinically significant medical condition. Current&#xD;
             medications interfering with glucose metabolism.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Timothy S Bailey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AMCR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>WCCT</name>
      <address>
        <city>Cypress</city>
        <state>California</state>
        <zip>90630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>September 11, 2019</last_update_submitted>
  <last_update_submitted_qc>September 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>inhaled insulin</keyword>
  <keyword>asthma</keyword>
  <keyword>COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Lispro</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03307512
org study id: Samba-AC
nct id: NCT03307512
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This will be a randomized, open-label, active-controlled, single dose crossover study with
      either three or four treatment periods. Investigational treatment is with Dance 501 Human
      Insulin Inhalation Solution (Dance 501) and the comparator is Insulin Lispro (Humalog®).

      Target population will be Non-Diabetic individuals with mild to moderate asthma or chronic
      obstructive pulmonary disease (COPD) and non-diabetic individuals without underlying lung
      disease (healthy subjects).
The PK and PD profile of Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be
      compared to subcutaneous injection of insulin lispro.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized, open-label, cross-over design
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the insulin curve (AUC)
time frame: 10 hours
description: Area under the insulin curve (AUC)
measure: Area under the glucose infusion rate curve (GIR)
time frame: 10 hours
description: Area under the glucose infusion rate curve (GIR)
measure: Area under the insulin curve following inhalation of salbutamol
time frame: 10 hours
description: Area under the insulin curve following inhalation of salbutamol in subjects with asthma
arm group label: Dance 501
arm group type: Experimental
description: Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
arm group label: Insulin Lispro
arm group type: Active Comparator
description: Insulin Lispro (Humalog®) will be administered by subcutaneous injection
intervention type: Drug
intervention name: inhaled human insulin
description: Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
arm group label: Dance 501
other name: Dance 501
intervention type: Drug
intervention name: Insulin Lispro (Humalog U-100)
description: Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection
arm group label: Insulin Lispro
other name: Lispro
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Timothy S Bailey, MD
role: Principal Investigator
affiliation: AMCR
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Lispro
sharing ipd: No