<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/NCT01708044</url>
  </required_header>
  <id_info>
    <org_study_id>D5570C00001</org_study_id>
    <nct_id>NCT01708044</nct_id>
  </id_info>
  <brief_title>Effect of Different Fixed Pramlintide:Insulin Dose Ratios on Postprandial Glucose in T1DM</brief_title>
  <official_title>A Phase 1, Randomized, Placebo-Controlled Single-Blind, Dose-Ranging, 4-Way Crossover Study to Evaluate the Effect of Different Fixed Pramlintide: Insulin Dose Ratios on Postprandial Glycemic Control in Subjects With Type 1 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Juvenile Diabetes Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To examine the effects of different fixed pramlintide:insulin dose ratios in subjects with&#xD;
      type 1 diabetes on postprandial plasma glucose concentrations&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incremental area under the concentration-time curve (AUC(0-3 h)) of plasma glucose concentrations for each treatment</measure>
    <time_frame>AUC 0-3 hrs compared to Placebo</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incremental AUC (0-3 h) of plasma glucagon</measure>
    <time_frame>0-3 hrs compared to Placebo</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute AUC (0-3 h), peak plasma concentration (Cmax), Cave, and Tmax of glucagon of plasma glucose.</measure>
    <time_frame>0-3 hrs compared to Placebo</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK of pramlintide</measure>
    <time_frame>0-3 hrs compared to Placebo</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>0-3 hrs compared to Placebo</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Pramlintide 6 mcg per unit of insulin dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 6 mcg for each unit of insulin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pramlintide 9 mcg per unit of insulin dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 9 mcg for each unit of insulin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pramlintide 12 mcg per unit of insulin dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 12 mcg for each unit of insulin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramlintide acetate</intervention_name>
    <arm_group_label>Pramlintide 12 mcg per unit of insulin dose</arm_group_label>
    <arm_group_label>Pramlintide 6 mcg per unit of insulin dose</arm_group_label>
    <arm_group_label>Pramlintide 9 mcg per unit of insulin dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo Comparator</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is 18 to 70 years old&#xD;
&#xD;
          -  Is male, or is female and meets all the following criteria:&#xD;
&#xD;
               1. Not breastfeeding&#xD;
&#xD;
               2. Negative pregnancy test result and, if of childbearing potential, must practice&#xD;
                  and be willing to continue to practice appropriate birth control&#xD;
&#xD;
          -  Has been diagnosed with type 1 diabetes mellitus for at least 1 year and not achieving&#xD;
             glycemic goal while on MDI of insulin&#xD;
&#xD;
          -  Has HbA1c between 7.0% and 9.0%&#xD;
&#xD;
          -  Has been on MDI of regular insulin, at a dose not to exceed 10 units/breakfast for at&#xD;
             least 3 months or has been on continuous subcutaneous insulin infusion (CSII), at a&#xD;
             dose not to exceed 10 units/breakfast, for at least 3 months and is willing to switch&#xD;
             to an MDI insulin regimen for 1 day prior to enrollment and through the study&#xD;
&#xD;
          -  Has a body mass index (BMI) &lt;30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has experienced recurrent severe hypoglycemia requiring assistance within 6 months&#xD;
             before Visit 1 Screening&#xD;
&#xD;
          -  Has a history of hypoglycemia unawareness&#xD;
&#xD;
          -  Has a confirmed diagnosis of gastroparesis&#xD;
&#xD;
          -  Has been treated, is currently being treated, or is expected to require or undergo&#xD;
             treatment with the following medications:&#xD;
&#xD;
               1. Any antihyperglycemic agent other than insulin&#xD;
&#xD;
               2. Drugs that directly affect gastrointestinal motility (e.g., anticholinergic&#xD;
                  agents such as atropine)&#xD;
&#xD;
               3. Drugs that slow the intestinal absorption of nutrients (e.g., α-glucosidase&#xD;
                  inhibitors.&#xD;
&#xD;
          -  Has a clinically significant medical condition that could potentially affect study&#xD;
             participation and/or personal well-being, as judged by the investigator, including but&#xD;
             not limited to the following conditions:&#xD;
&#xD;
               1. Hepatic disease&#xD;
&#xD;
               2. Renal disease&#xD;
&#xD;
               3. Gastrointestinal disease&#xD;
&#xD;
               4. Pulmonary disease&#xD;
&#xD;
               5. Organ transplantation&#xD;
&#xD;
               6. Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B&#xD;
                  virus, or hepatitis C virus)&#xD;
&#xD;
          -  Is currently treated or has been previously treated with SYMLIN/pramlintide or has&#xD;
             participated in a SYMLIN/pramlintide clinical study within 3 months of Visit 1&#xD;
             (Screening).&#xD;
&#xD;
          -  Has any clinically significant laboratory findings or medical history that may affect&#xD;
             successful completion of the study and/or personal well-being&#xD;
&#xD;
          -  Has donated blood within 2 months or is planning to donate blood during the study.&#xD;
&#xD;
          -  Has had a major surgery or a blood transfusion within 2 months&#xD;
&#xD;
          -  Has received any investigational drug within 1 month&#xD;
&#xD;
          -  Has known allergies or hypersensitivity to any component of study treatment.&#xD;
&#xD;
          -  Is an immediate family member of personnel directly affiliated with the study at the&#xD;
             clinical study site, or is directly affiliated with the study at the clinical study&#xD;
             site.&#xD;
&#xD;
          -  Is employed by Amylin Pharmaceuticals, Inc (Amylin) (that is an employee, temporary&#xD;
             contract worker, or designee responsible for the conduct of the study).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=2632&amp;filename=ABA163_D5570C0001_CSR_Synopsis_Final_2014_08_27.pdf</url>
    <description>ABA163_D5570C0001_CSR Synopsis</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 17, 2014</last_update_submitted>
  <last_update_submitted_qc>October 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pramlintide,</keyword>
  <keyword>insulin,</keyword>
  <keyword>type 1 diabetes,</keyword>
  <keyword>reduction in postprandial glucose,</keyword>
  <keyword>pramlintide:insulin dose-ratio</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pramlintide</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01708044
org study id: D5570C00001
nct id: NCT01708044
lead sponsor: 
collaborator: 
has dmc: No
To examine the effects of different fixed pramlintide:insulin dose ratios in subjects with
      type 1 diabetes on postprandial plasma glucose concentrations
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Incremental area under the concentration-time curve (AUC(0-3 h)) of plasma glucose concentrations for each treatment
time frame: AUC 0-3 hrs compared to Placebo
measure: Incremental AUC (0-3 h) of plasma glucagon
time frame: 0-3 hrs compared to Placebo
measure: Absolute AUC (0-3 h), peak plasma concentration (Cmax), Cave, and Tmax of glucagon of plasma glucose.
time frame: 0-3 hrs compared to Placebo
measure: PK of pramlintide
time frame: 0-3 hrs compared to Placebo
measure: Safety
time frame: 0-3 hrs compared to Placebo
arm group label: Pramlintide 6 mcg per unit of insulin dose
arm group type: Experimental
description: The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 6 mcg for each unit of insulin.
arm group label: Pramlintide 9 mcg per unit of insulin dose
arm group type: Experimental
description: The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 9 mcg for each unit of insulin.
arm group label: Pramlintide 12 mcg per unit of insulin dose
arm group type: Experimental
description: The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 12 mcg for each unit of insulin.
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Pramlintide acetate
arm group label: Pramlintide 12 mcg per unit of insulin dose
arm group label: Pramlintide 6 mcg per unit of insulin dose
arm group label: Pramlintide 9 mcg per unit of insulin dose
intervention type: Other
intervention name: Placebo
description: Placebo Comparator
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2632&filename=ABA163_D5570C0001_CSR_Synopsis_Final_2014_08_27.pdf
description: ABA163_D5570C0001_CSR Synopsis
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
mesh term: Pramlintide