<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/NCT01721382</url>
  </required_header>
  <id_info>
    <org_study_id>CFRD-01</org_study_id>
    <nct_id>NCT01721382</nct_id>
  </id_info>
  <brief_title>Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis</brief_title>
  <official_title>Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nemours Children's Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nemours Children's Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes&#xD;
      but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose&#xD;
      regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT),&#xD;
      will be performed at baseline and again ~4 weeks after treatment with study drug. We will&#xD;
      also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before&#xD;
      each time the MMTT/OGTT are performed. Several hormones that may affect the way the body&#xD;
      regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will&#xD;
      assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine&#xD;
      has on the hormones measured during the OGTT and MMTT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response to sitagliptin</measure>
    <time_frame>Change from baseline to ~4 weeks of study drug</time_frame>
    <description>Baseline and stimulated C-peptide levels (using mixed meal tolerance test) before and after treatment with sitagliptin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response to sitagliptin</measure>
    <time_frame>Change from baseline to ~4 weeks of study drug</time_frame>
    <description>Change in glycemic variability using continuous glucose monitoring data before and after treatment with dipeptidyl peptidase-4 inhibitor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response to sitagliptin</measure>
    <time_frame>Change from baseline to ~4 weeks of study drug</time_frame>
    <description>Change in incretins concentrations (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) in response to study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response to sitagliptin</measure>
    <time_frame>Change from baseline to ~4 weeks of study drug</time_frame>
    <description>Change in incretin (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) concentrations in response to study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Beta-cell function</measure>
    <time_frame>Change from baseline to ~4 weeks of study drug</time_frame>
    <description>Beta-cell function will be measured using mixed meal tolerance tests (MMTT) and oral glucose tolerance tests (OGTT), assessing maximum concentration and area under the curve (AUC) of glucose, insulin and c-peptide for both OGTT and MMTT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous glucose monitoring (CGM)</measure>
    <time_frame>change from baseline to ~4 weeks of study drug</time_frame>
    <description>Baseline and post-treatment changes in glycemic variability using CGM, including mean amplitude of glycemic excursion (MAGE), peak post-prandial blood sugars, and glucose area under the curve.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Sitagliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with sitagliptin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin</intervention_name>
    <arm_group_label>Sitagliptin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with CF between 13 and &lt;21 yrs old&#xD;
&#xD;
          -  Known impaired or indeterminate glucose tolerance (based on a prior OGTT)&#xD;
&#xD;
          -  No history of CFRD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insulin use in the last two months&#xD;
&#xD;
          -  Acute pulmonary exacerbation / oral corticosteroid use in the last 6 weeks&#xD;
&#xD;
          -  History of pancreatitis in the last 12 months&#xD;
&#xD;
          -  Skin rashes or conditions that may affect CGM placement and wear&#xD;
&#xD;
          -  Pregnancy or intent on becoming pregnant&#xD;
&#xD;
          -  Patients on growth hormone therapy&#xD;
&#xD;
          -  Renal insufficiency with creatinine clearance &lt;50 ml/min (based on Schwartz formula)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Larry A Fox, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nemours Children's Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nemours Children's Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>June 10, 2016</last_update_submitted>
  <last_update_submitted_qc>June 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nemours Children's Clinic</investigator_affiliation>
    <investigator_full_name>Larry Fox</investigator_full_name>
    <investigator_title>Pediatric Endocrinologist</investigator_title>
  </responsible_party>
  <keyword>cystic fibrosis</keyword>
  <keyword>CF</keyword>
  <keyword>CFRD</keyword>
  <keyword>sitagliptin</keyword>
  <keyword>incretins</keyword>
  <keyword>GLP1</keyword>
  <keyword>GIP</keyword>
  <keyword>beta cell function</keyword>
  <keyword>adolescents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sitagliptin Phosphate</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/NCT01721382
org study id: CFRD-01
nct id: NCT01721382
lead sponsor: 
has dmc: No
This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes
      but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose
      regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT),
      will be performed at baseline and again ~4 weeks after treatment with study drug. We will
      also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before
      each time the MMTT/OGTT are performed. Several hormones that may affect the way the body
      regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will
      assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine
      has on the hormones measured during the OGTT and MMTT.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Response to sitagliptin
time frame: Change from baseline to ~4 weeks of study drug
description: Baseline and stimulated C-peptide levels (using mixed meal tolerance test) before and after treatment with sitagliptin.
measure: Response to sitagliptin
time frame: Change from baseline to ~4 weeks of study drug
description: Change in glycemic variability using continuous glucose monitoring data before and after treatment with dipeptidyl peptidase-4 inhibitor.
measure: Response to sitagliptin
time frame: Change from baseline to ~4 weeks of study drug
description: Change in incretins concentrations (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) in response to study drug.
measure: Response to sitagliptin
time frame: Change from baseline to ~4 weeks of study drug
description: Change in incretin (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) concentrations in response to study drug.
measure: Beta-cell function
time frame: Change from baseline to ~4 weeks of study drug
description: Beta-cell function will be measured using mixed meal tolerance tests (MMTT) and oral glucose tolerance tests (OGTT), assessing maximum concentration and area under the curve (AUC) of glucose, insulin and c-peptide for both OGTT and MMTT.
measure: Continuous glucose monitoring (CGM)
time frame: change from baseline to ~4 weeks of study drug
description: Baseline and post-treatment changes in glycemic variability using CGM, including mean amplitude of glycemic excursion (MAGE), peak post-prandial blood sugars, and glucose area under the curve.
arm group label: Sitagliptin
arm group type: Experimental
description: Treatment with sitagliptin
intervention type: Drug
intervention name: Sitagliptin
arm group label: Sitagliptin
criteria: 
gender: All
minimum age: 13 Years
maximum age: 20 Years
healthy volunteers: No
last name: Larry A Fox, MD
role: Principal Investigator
affiliation: Nemours Children's Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Nemours Children's Clinic
investigator full name: Larry Fox
investigator title: Pediatric Endocrinologist
mesh term: Cystic Fibrosis
mesh term: Fibrosis
mesh term: Sitagliptin Phosphate