<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/NCT03770910</url>
  </required_header>
  <id_info>
    <org_study_id>SDCC_CMP_GA-10</org_study_id>
    <nct_id>NCT03770910</nct_id>
  </id_info>
  <brief_title>The Effect of GIP(3-30)NH2</brief_title>
  <acronym>GA-10</acronym>
  <official_title>The Effect of GIP(3-30)NH2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Gentofte, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Steno Diabetes Center Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Gentofte, Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and&#xD;
      evaluation of effect of insulin secretion in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and&#xD;
      evaluation of effect of insulin secretion in healthy subjects.&#xD;
&#xD;
      Six study hyperglycemic clamps (10 mmol/l) pr. participant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</primary_completion_date>
  <phase>N/A</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>Insulin secretion</measure>
    <time_frame>8 weeks</time_frame>
    <description>Insulin secretion rates (ISR) calculated from serum levels of C-peptide</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Endocrine - Other</condition>
  <arm_group>
    <arm_group_label>Placebo+placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline infusions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GIP+placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>GIP(1-42), receptor agonist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GIP+dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GIP(1-42) and lowest dose of GIP(3-30)NH2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GIP+dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GIP(1-42) and dose of GIP(3-30)NH2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GIP+dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GIP(1-42) and dose of GIP(3-30)NH2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GIP+dose4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GIP(1-42) and highest dose of GIP(3-30)NH2</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GIP receptor antagonist</intervention_name>
    <description>GIP receptor antagonist</description>
    <arm_group_label>GIP+dose 1</arm_group_label>
    <arm_group_label>GIP+dose 2</arm_group_label>
    <arm_group_label>GIP+dose 3</arm_group_label>
    <arm_group_label>GIP+dose4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GIP receptor agonist</intervention_name>
    <description>GIP(1-42)</description>
    <arm_group_label>GIP+dose 1</arm_group_label>
    <arm_group_label>GIP+dose 2</arm_group_label>
    <arm_group_label>GIP+dose 3</arm_group_label>
    <arm_group_label>GIP+dose4</arm_group_label>
    <arm_group_label>GIP+placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Placebo (vehicle for infusions)</description>
    <arm_group_label>GIP+placebo</arm_group_label>
    <arm_group_label>Placebo+placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  BMI 19-28 kg/m*m&#xD;
&#xD;
          -  Stable body weight&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Anemia&#xD;
&#xD;
          -  First-degree relatives with diabetes&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Metabolic Physiology</name>
      <address>
        <city>Gentofte</city>
        <state>Copenhagen</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Metabolic Physiology</name>
      <address>
        <city>Copenhagen</city>
        <state>Gentofte</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>March 25, 2020</last_update_submitted>
  <last_update_submitted_qc>March 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gentofte, Copenhagen</investigator_affiliation>
    <investigator_full_name>Lærke Smidt Gasbjerg</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>GIP</keyword>
  <keyword>Insulin secretin</keyword>
  <keyword>Incretin hormone</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be shared with other researchers unless data management agreements are signed.</ipd_description>
  </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/NCT03770910
org study id: SDCC_CMP_GA-10
nct id: NCT03770910
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and
      evaluation of effect of insulin secretion in healthy subjects.
Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and
      evaluation of effect of insulin secretion in healthy subjects.

      Six study hyperglycemic clamps (10 mmol/l) pr. participant.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Insulin secretion
time frame: 8 weeks
description: Insulin secretion rates (ISR) calculated from serum levels of C-peptide
arm group label: Placebo+placebo
arm group type: Placebo Comparator
description: Saline infusions
arm group label: GIP+placebo
arm group type: Active Comparator
description: GIP(1-42), receptor agonist
arm group label: GIP+dose 1
arm group type: Experimental
description: GIP(1-42) and lowest dose of GIP(3-30)NH2
arm group label: GIP+dose 2
arm group type: Experimental
description: GIP(1-42) and dose of GIP(3-30)NH2
arm group label: GIP+dose 3
arm group type: Experimental
description: GIP(1-42) and dose of GIP(3-30)NH2
arm group label: GIP+dose4
arm group type: Experimental
description: GIP(1-42) and highest dose of GIP(3-30)NH2
intervention type: Other
intervention name: GIP receptor antagonist
description: GIP receptor antagonist
arm group label: GIP+dose 1
arm group label: GIP+dose 2
arm group label: GIP+dose 3
arm group label: GIP+dose4
intervention type: Other
intervention name: GIP receptor agonist
description: GIP(1-42)
arm group label: GIP+dose 1
arm group label: GIP+dose 2
arm group label: GIP+dose 3
arm group label: GIP+dose4
arm group label: GIP+placebo
intervention type: Other
intervention name: Saline
description: Placebo (vehicle for infusions)
arm group label: GIP+placebo
arm group label: Placebo+placebo
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Gentofte, Copenhagen
investigator full name: Lærke Smidt Gasbjerg
investigator title: MD
sharing ipd: No
ipd description: IPD will not be shared with other researchers unless data management agreements are signed.