<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/NCT01718093</url>
  </required_header>
  <id_info>
    <org_study_id>H-29924</org_study_id>
    <secondary_id>DK096067</secondary_id>
    <nct_id>NCT01718093</nct_id>
  </id_info>
  <brief_title>A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes</brief_title>
  <official_title>A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if the use of metformin and sitagliptin used in&#xD;
      conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  The study will include a total of 4 visits. The time period between the very first visit&#xD;
           and the very last visit will be between 10 and 15 weeks. Each participant will be&#xD;
           randomized to one of the 3 groups in the study. The groups are as follows:&#xD;
&#xD;
        -  Group 1: Insulin and sitagliptin&#xD;
&#xD;
        -  Group 2: Insulin and metformin&#xD;
&#xD;
        -  Group 3: Insulin and combination of sitagliptin and metformin&#xD;
&#xD;
        -  The study is a randomized open label design. All subjects will undergo a screening&#xD;
           visit; if inclusion and exclusion criteria are fulfilled they will be enrolled in the&#xD;
           study. At the time of enrollment the subject will continue their home insulin regimen&#xD;
           and will be randomized to an add an oral hypoglycemic agent(s) : metformin, sitagliptin&#xD;
           or combination therapy (metformin and sitagliptin). The total duration on study&#xD;
           medication will be 6 weeks. All subjects will undergo a baseline mixed meal tolerance&#xD;
           test (MMTT) in their standard or usual insulin Each subject will undergo a total of two&#xD;
           studies. Blood draws will be necessary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the glucose lowering effect of metformin and sitagliptin alone and as combination therapy when used as adjuncts to insulin in adolescents with T1DM.</measure>
    <time_frame>10 - 15 weeks</time_frame>
    <description>Glucose concentrations and AUC glucose calculation</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Insulin plus sitagliptin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin plus metformin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subjects continued their usual insulin regimen throughout the study. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin plus sitagliptin and metformin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin</intervention_name>
    <description>up to 50 mg twice a day</description>
    <arm_group_label>Insulin plus sitagliptin</arm_group_label>
    <other_name>Januvia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>up to 1000 mg twice a day</description>
    <arm_group_label>Insulin plus metformin</arm_group_label>
    <other_name>Glucophage</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin + Metformin</intervention_name>
    <description>up to 50/1000 mg twice a day</description>
    <arm_group_label>Insulin plus sitagliptin and metformin</arm_group_label>
    <other_name>Sitagliptin + Metformin = Janumet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 13 to 18 years&#xD;
&#xD;
          -  HbA1c &gt;7.5% but &lt;10%&#xD;
&#xD;
          -  Subjects must be on intensive insulin management&#xD;
&#xD;
          -  Tanner stage greater than or equal to 4&#xD;
&#xD;
          -  Must have T1DM for at least one year , T1DM defined by ADA criteria and having at&#xD;
             least one of the following antibodies: Anti-GAD, Anti-islet, Anti-insulin&#xD;
&#xD;
          -  C-peptide &gt; 0.6 ng/ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes&#xD;
&#xD;
          -  History of any other chronic condition (except hypothyroidism stable on medications)&#xD;
&#xD;
          -  Actively taking medications that may affect glucose excursions (steroids or oral&#xD;
             contraceptives)&#xD;
&#xD;
          -  Evidence of anemia, clinically significant elevation of the liver enzymes (3 X&#xD;
             normal), amylase or lipase (2 X normal), abnormal triclycerides (3 X normal), abnormal&#xD;
             renal function test&#xD;
&#xD;
          -  An unsupportive family environment and pregnant or lactating females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luisa M. Rodriguez, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>April 21, 2017</last_update_submitted>
  <last_update_submitted_qc>April 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Luisa M. Rodriguez</investigator_full_name>
    <investigator_title>Assistant Professor - Department of Pediatrics - Endocrinology and Metabolism</investigator_title>
  </responsible_party>
  <keyword>Adolescents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <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>Metformin</mesh_term>
    <mesh_term>Sitagliptin Phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 4, 2020</submitted>
    <returned>December 30, 2020</returned>
  </pending_results>
  <!-- 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/NCT01718093
org study id: H-29924
secondary id: DK096067
nct id: NCT01718093
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to see if the use of metformin and sitagliptin used in
      conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes.
-  The study will include a total of 4 visits. The time period between the very first visit
           and the very last visit will be between 10 and 15 weeks. Each participant will be
           randomized to one of the 3 groups in the study. The groups are as follows:

        -  Group 1: Insulin and sitagliptin

        -  Group 2: Insulin and metformin

        -  Group 3: Insulin and combination of sitagliptin and metformin

        -  The study is a randomized open label design. All subjects will undergo a screening
           visit; if inclusion and exclusion criteria are fulfilled they will be enrolled in the
           study. At the time of enrollment the subject will continue their home insulin regimen
           and will be randomized to an add an oral hypoglycemic agent(s) : metformin, sitagliptin
           or combination therapy (metformin and sitagliptin). The total duration on study
           medication will be 6 weeks. All subjects will undergo a baseline mixed meal tolerance
           test (MMTT) in their standard or usual insulin Each subject will undergo a total of two
           studies. Blood draws will be necessary.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To determine the glucose lowering effect of metformin and sitagliptin alone and as combination therapy when used as adjuncts to insulin in adolescents with T1DM.
time frame: 10 - 15 weeks
description: Glucose concentrations and AUC glucose calculation
arm group label: Insulin plus sitagliptin
arm group type: Active Comparator
description: The subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily
arm group label: Insulin plus metformin
arm group type: Active Comparator
description: The subjects continued their usual insulin regimen throughout the study. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated.
arm group label: Insulin plus sitagliptin and metformin
arm group type: Active Comparator
description: The subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated.
intervention type: Drug
intervention name: Sitagliptin
description: up to 50 mg twice a day
arm group label: Insulin plus sitagliptin
other name: Januvia
intervention type: Drug
intervention name: Metformin
description: up to 1000 mg twice a day
arm group label: Insulin plus metformin
other name: Glucophage
intervention type: Drug
intervention name: Sitagliptin + Metformin
description: up to 50/1000 mg twice a day
arm group label: Insulin plus sitagliptin and metformin
other name: Sitagliptin + Metformin = Janumet
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: No
last name: Luisa M. Rodriguez, MD, MS
role: Principal Investigator
affiliation: Baylor College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Luisa M. Rodriguez
investigator title: Assistant Professor - Department of Pediatrics - Endocrinology and Metabolism
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Metformin
mesh term: Sitagliptin Phosphate
sharing ipd: No
submitted: December 4, 2020
returned: December 30, 2020