<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/NCT02265276</url>
  </required_header>
  <id_info>
    <org_study_id>ENDO/2014/4</org_study_id>
    <nct_id>NCT02265276</nct_id>
  </id_info>
  <brief_title>A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease</brief_title>
  <acronym>GLAZED</acronym>
  <official_title>A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease (GLAZED Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Command Hospital, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Command Hospital, India</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non Alcoholic Fatty Liver Disease (NAFLD) is considered as the component of metabolic&#xD;
      syndrome. The prevalence of the same has been increasing rapidly in India, along with an&#xD;
      increase in the prevalence of diabetes and obesity. Insulin resistance is the key underlying&#xD;
      pathogenetic mechanism of NAFLD. NAFLD accounts for significant morbidity and mortality and&#xD;
      the therapeutic options are limited. Insulin sensitizing drugs are used in the management of&#xD;
      NAFLD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The therapeutic options for the management of nonalcoholic fatty liver disease (NAFLD)&#xD;
      include lifestyle modifications, insulin sensitizers, vitamin E, antioxidants and&#xD;
      cytoprotective agents. Glitazones are insulin sensitizing drugs and act by stimulating the&#xD;
      PPAR gamma receptors. The drugs like Pioglitazone and Rosiglitazone have shown conflicting&#xD;
      results in the NAFLD trials. Dual PPAR stimulators (PPAR gamma and PPAR alfa) are known as&#xD;
      the &quot;Glitazars&quot; and are useful in simultaneously controlling the hyperglycemia, dyslipidemia&#xD;
      and insulin resistance. Saroglitazar is the first drug approved in the investigators country&#xD;
      for the management of diabetic dyslipidemia. The investigators plan to study the efficacy of&#xD;
      this drug in comparison to Pioglitazone in patients of NAFLD over a period of 24 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the NAFLD fibrosis score</measure>
    <time_frame>At baseline and the end of 24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body composition</measure>
    <time_frame>At baseline and the end of 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin resistance</measure>
    <time_frame>At baseline and the end of 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lipid profile</measure>
    <time_frame>At baseline and the end of 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>At baseline and the end of 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Fatty Liver</condition>
  <arm_group>
    <arm_group_label>Saroglitazar Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pioglitazone Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Tab Pioglitazone 30 mg daily fixed dose for 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saroglitazar</intervention_name>
    <description>Tab Saroglitazar 4 mg oral daily for 24 weeks</description>
    <arm_group_label>Saroglitazar Group</arm_group_label>
    <other_name>Glitazar group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pioglitazone</intervention_name>
    <description>Tab Pioglitazone 30 mg oral daily for 24 weeks</description>
    <arm_group_label>Pioglitazone Group</arm_group_label>
    <other_name>Placebo Comparator group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Drug naive patients with NAFLD diagnosed on ultrasonography, BMI &gt; 23 kg/m2 and ALT &gt;&#xD;
             1.5 times the upper limit of normal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any drugs other than lifestyle modification for NAFLD, HbA1c &gt; 8% FBS&gt;200,&#xD;
             Bilirubin &gt; 1.5 mg/dL&#xD;
&#xD;
          -  Any illness likely to cause transaminitis and positive viral markers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hari Kumar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Command Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hari Kumar, MD</last_name>
    <phone>00918146141700</phone>
    <email>hariendo@rediffmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Command Hospital</name>
      <address>
        <city>Panchkula</city>
        <state>Haryana</state>
        <zip>134107</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>JBS Yadava</last_name>
      <phone>00911722867534</phone>
      <email>hariendo@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Command Hospital, India</investigator_affiliation>
    <investigator_full_name>Hari Kumar</investigator_full_name>
    <investigator_title>Endocrinologist</investigator_title>
  </responsible_party>
  <keyword>NAFLD, Diabetes, Glitazone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pioglitazone</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/NCT02265276
org study id: ENDO/2014/4
nct id: NCT02265276
lead sponsor: 
has dmc: No
Non Alcoholic Fatty Liver Disease (NAFLD) is considered as the component of metabolic
      syndrome. The prevalence of the same has been increasing rapidly in India, along with an
      increase in the prevalence of diabetes and obesity. Insulin resistance is the key underlying
      pathogenetic mechanism of NAFLD. NAFLD accounts for significant morbidity and mortality and
      the therapeutic options are limited. Insulin sensitizing drugs are used in the management of
      NAFLD.
The therapeutic options for the management of nonalcoholic fatty liver disease (NAFLD)
      include lifestyle modifications, insulin sensitizers, vitamin E, antioxidants and
      cytoprotective agents. Glitazones are insulin sensitizing drugs and act by stimulating the
      PPAR gamma receptors. The drugs like Pioglitazone and Rosiglitazone have shown conflicting
      results in the NAFLD trials. Dual PPAR stimulators (PPAR gamma and PPAR alfa) are known as
      the "Glitazars" and are useful in simultaneously controlling the hyperglycemia, dyslipidemia
      and insulin resistance. Saroglitazar is the first drug approved in the investigators country
      for the management of diabetic dyslipidemia. The investigators plan to study the efficacy of
      this drug in comparison to Pioglitazone in patients of NAFLD over a period of 24 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in the NAFLD fibrosis score
time frame: At baseline and the end of 24 weeks
measure: Change in body composition
time frame: At baseline and the end of 24 weeks
measure: Change in insulin resistance
time frame: At baseline and the end of 24 weeks
measure: Change in lipid profile
time frame: At baseline and the end of 24 weeks
measure: Change in HbA1c
time frame: At baseline and the end of 24 weeks
arm group label: Saroglitazar Group
arm group type: Active Comparator
description: Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks
arm group label: Pioglitazone Group
arm group type: Placebo Comparator
description: Tab Pioglitazone 30 mg daily fixed dose for 24 weeks
intervention type: Drug
intervention name: Saroglitazar
description: Tab Saroglitazar 4 mg oral daily for 24 weeks
arm group label: Saroglitazar Group
other name: Glitazar group
intervention type: Drug
intervention name: Pioglitazone
description: Tab Pioglitazone 30 mg oral daily for 24 weeks
arm group label: Pioglitazone Group
other name: Placebo Comparator group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Hari Kumar, MD
role: Principal Investigator
affiliation: Command Hospital
last name: Hari Kumar, MD
phone: 00918146141700
email: hariendo@rediffmail.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Command Hospital, India
investigator full name: Hari Kumar
investigator title: Endocrinologist
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Pioglitazone