<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/NCT01722227</url>
  </required_header>
  <id_info>
    <org_study_id>1964 Liraglutide ADA</org_study_id>
    <secondary_id>1-12-CT-20</secondary_id>
    <nct_id>NCT01722227</nct_id>
  </id_info>
  <brief_title>Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes</brief_title>
  <official_title>Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Diabetes Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University at Buffalo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is the first prospective randomized double-blind placebo-controlled study to investigate&#xD;
      the effect of a GLP-1 analog, specifically liraglutide, on blood glucose levels and&#xD;
      variability in subjects with type 1 diabetes treated with insulin. Liraglutide is the&#xD;
      preferred GLP-1 analog for this study because the pharmacokinetics and pharmacodynamics of&#xD;
      the drug are consistent with a sustained duration of action. The current gold standard for&#xD;
      management of type 1 diabetes is based on insulin replacement with novel analogs with&#xD;
      specified pharmacodynamic profiles or with unique insulin delivery systems (insulin pump&#xD;
      therapy). No other adjuvant therapy has demonstrated sustained benefit in this population.&#xD;
      This study will also investigate the effect of liraglutide on suppression of glucagon&#xD;
      secretion during meal challenges. This is of particular importance since, in the absence of&#xD;
      insulin secretion from the β-cell, there is no paracrine inhibition of glucagon secretion by&#xD;
      the α-cell. Dysregulation of glucagon secretion may impact the glycemic control and overall&#xD;
      pathogenesis in those with type 1 diabetes. The use of CGM technology in this study will&#xD;
      allow us to determine the rapidity, consistency, and sustainability of any response to&#xD;
      liraglutide.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No Funding Received from ADA&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean weekly blood glucose concentrations.</measure>
    <time_frame>3 Months</time_frame>
    <description>The primary endpoint of the study is to detect a difference between Liraglutide and placebo groups in the change from baseline in mean weekly blood glucose concentrations after 12 weeks of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>3 Months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Liraglutide 0.6mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Daily Injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Daily Injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liraglutide</intervention_name>
    <arm_group_label>Liraglutide 0.6mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  INCLUSION CRITERIA:&#xD;
&#xD;
               1. Females and males with Type 1 diabetes as ascertained by islet autoantibodies&#xD;
                  (GAD-65 and/or islet cell antibodies)&#xD;
&#xD;
               2. Age 15-30 years - This age group is being chosen as most will have completed&#xD;
                  puberty with the accompanying physiologic phase of increased insulin resistance.&#xD;
                  In addition, this age group shows increased self-management capabilities.&#xD;
                  Extending the age up to 30 years will allow us to include young adults, since&#xD;
                  type 1 diabetes is frequently diagnosed in the late teen and early adult years.&#xD;
                  This study is not powered to detect differences in liraglutide efficacy in&#xD;
                  different age group but it may provide insight into the effectiveness in the&#xD;
                  teenage population, in whom optimal glycemic control is often a challenge.&#xD;
&#xD;
               3. Type 1 diabetes duration greater than 1 year to ensure that a majority of&#xD;
                  subjects are beyond the partial remission period.&#xD;
&#xD;
               4. Fasting C-peptide level ≤ 0.3 ng/ml.&#xD;
&#xD;
               5. HbA1c level equal or less than 9%&#xD;
&#xD;
               6. Insulin delivery by CSII - the choice is made to facilitate adherence to study&#xD;
                  drug and also to enable us have a homogeneous group to analyze without having to&#xD;
                  analyze the data for the covariants of CSII vs. multiple daily injection therapy.&#xD;
&#xD;
               7. Subjects willing to wear a CGM sensor and perform home blood glucose monitoring&#xD;
                  four times daily and with symptoms of hypoglycemia.&#xD;
&#xD;
               8. Subjects well-versed in carbohydrate counting.&#xD;
&#xD;
               9. BMI &lt; 95th% for age and gender.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  EXCLUSION CRITERIA:&#xD;
&#xD;
               1. Previous exposure to liraglutide&#xD;
&#xD;
               2. History of abdominal surgery&#xD;
&#xD;
               3. History of gastroparesis or gastrointestinal reflux disease;&#xD;
&#xD;
               4. History of acute or chronic pancreatitis&#xD;
&#xD;
               5. Cirrhosis or hepatic disease defined as transaminases levels &gt; 3 times normal&#xD;
&#xD;
               6. Impaired renal function defined as serum creatinine &gt;1.5.&#xD;
&#xD;
               7. HIV or Hepatitis C positive status&#xD;
&#xD;
               8. Pregnant/breastfeeding females&#xD;
&#xD;
               9. Individuals with steroid-induced or cystic fibrosis related diabetes&#xD;
&#xD;
              10. Diabetic Ketoacidosis within 6 months of the study&#xD;
&#xD;
              11. History of severe hypoglycemia (seizure, loss of consciousness) within 6 months&#xD;
                  of the study&#xD;
&#xD;
              12. History of medullary thyroid cancer or MEN2 syndrome&#xD;
&#xD;
              13. Any other life-threatening cardiac or non-cardiac disease&#xD;
&#xD;
              14. Participation in a concurrent clinical trial or participation in a trial within&#xD;
                  30 days preceding the study period.&#xD;
&#xD;
              15. Unable to give informed consent/assent.&#xD;
&#xD;
              16. Adolescents and adults who are considered underweight based on body mass index&#xD;
                  (BMI):&#xD;
&#xD;
                    1. For adolescents: BMI less than the 5th percentile&#xD;
&#xD;
                    2. For adults: BMI below 18.5&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Diabetes-Endocrinology Center of WNY</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>February 8, 2017</last_update_submitted>
  <last_update_submitted_qc>February 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kaleida Health</investigator_affiliation>
    <investigator_full_name>Paresh Dandona</investigator_full_name>
    <investigator_title>Distinguished Professor of Medicine</investigator_title>
  </responsible_party>
  <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>Liraglutide</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/NCT01722227
org study id: 1964 Liraglutide ADA
secondary id: 1-12-CT-20
nct id: NCT01722227
lead sponsor: 
collaborator: 
has dmc: No
This is the first prospective randomized double-blind placebo-controlled study to investigate
      the effect of a GLP-1 analog, specifically liraglutide, on blood glucose levels and
      variability in subjects with type 1 diabetes treated with insulin. Liraglutide is the
      preferred GLP-1 analog for this study because the pharmacokinetics and pharmacodynamics of
      the drug are consistent with a sustained duration of action. The current gold standard for
      management of type 1 diabetes is based on insulin replacement with novel analogs with
      specified pharmacodynamic profiles or with unique insulin delivery systems (insulin pump
      therapy). No other adjuvant therapy has demonstrated sustained benefit in this population.
      This study will also investigate the effect of liraglutide on suppression of glucagon
      secretion during meal challenges. This is of particular importance since, in the absence of
      insulin secretion from the β-cell, there is no paracrine inhibition of glucagon secretion by
      the α-cell. Dysregulation of glucagon secretion may impact the glycemic control and overall
      pathogenesis in those with type 1 diabetes. The use of CGM technology in this study will
      allow us to determine the rapidity, consistency, and sustainability of any response to
      liraglutide.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Mean weekly blood glucose concentrations.
time frame: 3 Months
description: The primary endpoint of the study is to detect a difference between Liraglutide and placebo groups in the change from baseline in mean weekly blood glucose concentrations after 12 weeks of treatment.
measure: HbA1c
time frame: 3 Months
arm group label: Liraglutide 0.6mg
arm group type: Active Comparator
description: Daily Injection
arm group label: Placebo
arm group type: Placebo Comparator
description: Daily Injection
intervention type: Drug
intervention name: Liraglutide
arm group label: Liraglutide 0.6mg
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 15 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Kaleida Health
investigator full name: Paresh Dandona
investigator title: Distinguished Professor of Medicine
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Liraglutide