<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/NCT03796975</url>
  </required_header>
  <id_info>
    <org_study_id>KY20172053-1</org_study_id>
    <nct_id>NCT03796975</nct_id>
  </id_info>
  <brief_title>Efficacy of Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets on the Patients With Newly Diagnosed Type 2 Diabetes Mellitus Combined With Non-alcoholic Fatty Liver Disease</brief_title>
  <official_title>Efficacy of Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets on the Patients With Newly Diagnosed Type 2 Diabetes Mellitus Combined With Non-alcoholic Fatty Liver Disease：an Multicenter，Randomized, Double-blind, Parallel- Controlled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Second Affiliated Hospital of Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shaanxi Aerospace Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xi'an Gaoxin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chang'An Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yan'an people's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shangluo Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an multicenter, randomized, double-blind, parallel-controlled study to evaluated the&#xD;
      efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on the patients&#xD;
      with newly diagnosed type 2 diabetes mellitus combined with non-alcoholic fatty liver&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Taking metformin monotherapy as a control, we evaluated the efficacy of pioglitazone&#xD;
      hydrochloride and metformin hydrochloride tablets on hepatic fat ultrasound and liver enzyme&#xD;
      levels, and observed whether the drug can improve fatty liver in patients with newly&#xD;
      diagnosed type 2 diabetes combined with non-alcoholic fatty liver disease. This is an&#xD;
      multicenter, randomized, double-blind, parallel-controlled study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2018</start_date>
  <completion_date type="Actual">November 20, 2019</completion_date>
  <primary_completion_date type="Actual">April 28, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decreased of liver fat content of fatty liver after 24 weeks treatment as assessed by B-ultrasound</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Change from baseline liver fat content to up to 24 weeks after treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of B-cell function after 24 weeks treatment as assessed by homeostasis model assessment of insulin resistance index</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Change from baseline B-cell function to up to 24 weeks after treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of liver enzyme after 24 weeks treatment as assessed by blood test</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Change from baseline liver enzyme to up to 24 weeks after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decreased of HbA1c after 24 weeks treatment as assessed by blood test</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Change from baseline HbA1c to up to 24 weeks after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decreased of fasting blood glucose after 24 weeks treatment as assessed by blood test</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Change from baseline fasting blood glucose to up to 24 weeks after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of weight and waistline after 24 weeks treatment as assessed by standard measurement</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Change from baseline weight and waistline to up to 24 weeks after treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Non-alcoholic Fatty Liver Disease</condition>
  <condition>Efficacy</condition>
  <arm_group>
    <arm_group_label>Combination of Pioglitazone and Metformin Tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dosage form: tablet; dosage:15mg/500mg; frequency: the dose in week 1 is 15mg/500mg, once a day, increased to 15mg/500mg in the second week, twice a day and maintain this dose to 24 weeks duration: 24 weeks; type: oral;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metformin Hydrochloride Tablets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>dosage form: tablet; dosage: 850mg; frequency: the dose in week 1 is 850mg, once a day, increased to 850mg in the second week, twice a day and maintain this dose to 24 weeks duration: 24 weeks; type: oral;</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Combination of Pioglitazone and Metformin Tablets</intervention_name>
    <description>15mg/500mg, oral, 2/day</description>
    <arm_group_label>Combination of Pioglitazone and Metformin Tablets</arm_group_label>
    <other_name>ka shuang ping</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin Hydrochloride Tablets</intervention_name>
    <description>Oral metformin 850mg, 2/day in the control group</description>
    <arm_group_label>Metformin Hydrochloride Tablets</arm_group_label>
    <other_name>ge hua zhi</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. To meet the new diagnosed type 2 diabetes patients, never received oral hypoglycemic&#xD;
             drugs or insulin therapy;&#xD;
&#xD;
          2. In accordance with the nonalcoholic fatty liver (NAFLD) criteria for the diagnosis of&#xD;
             patients.&#xD;
&#xD;
          3. the level of HbA1c was 7 -10.0%;&#xD;
&#xD;
          4. age 18-70, body mass index 21-35kg/m2;&#xD;
&#xD;
          5. the subjects informed consent and signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. type 1 diabetes or secondary diabetes;&#xD;
&#xD;
          2. suffering from other liver diseases, such as hepatitis, self - free liver, etc.&#xD;
&#xD;
          3. abnormal thyroid function (in the active period), or the need for long-term oral and&#xD;
             intravenous glucocorticoids to treat patients;&#xD;
&#xD;
          4. patients with severe renal dysfunction or renal disease (eGFR&lt;60);&#xD;
&#xD;
          5. in those with abnormal liver function, Alanine transaminase(ALT) or Aspartate&#xD;
             transaminase(AST) was more than 3 times the normal upper limit.&#xD;
&#xD;
          6. people with serious gastrointestinal diseases such as peptic ulcers and chronic&#xD;
             diarrhea;&#xD;
&#xD;
          7. patients with severe cardiopulmonary disease, cerebrovascular disease or stents;&#xD;
&#xD;
          8. hemopoietic system diseases such as serious primary diseases, hemoglobin &lt; 100g/L or&#xD;
             need regular transfusion treatment;&#xD;
&#xD;
          9. pregnant, breast-feeding, women of childbearing age who are unwilling to contraception&#xD;
             during the study period;&#xD;
&#xD;
         10. chronic cardiac insufficiency, the classification of heart function III level and&#xD;
             above;&#xD;
&#xD;
         11. uncontrolled malignant tumor, and the history of bladder cancer.&#xD;
&#xD;
         12. acute complications of diabetes;&#xD;
&#xD;
         13. the use of other drugs for diabetes and liver disease;&#xD;
&#xD;
         14. patients who had participated in other clinical studies within three months;&#xD;
&#xD;
         15. people who have known allergies to this kind of drugs are known.&#xD;
&#xD;
         16. it is impossible to guarantee the effect or the safety judgment of the drug or the&#xD;
             person who is unable to cooperate with the mental illness.&#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>Qiuhe Ph.D Ji, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xijing Hospital, Fourth Military Medical university</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 11, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 Diabetes Mellitus</keyword>
  <keyword>Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <keyword>Non-alcoholic Fatty Liver Disease</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>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Pioglitazone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03796975
org study id: KY20172053-1
nct id: NCT03796975
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an multicenter, randomized, double-blind, parallel-controlled study to evaluated the
      efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on the patients
      with newly diagnosed type 2 diabetes mellitus combined with non-alcoholic fatty liver
      disease.
Taking metformin monotherapy as a control, we evaluated the efficacy of pioglitazone
      hydrochloride and metformin hydrochloride tablets on hepatic fat ultrasound and liver enzyme
      levels, and observed whether the drug can improve fatty liver in patients with newly
      diagnosed type 2 diabetes combined with non-alcoholic fatty liver disease. This is an
      multicenter, randomized, double-blind, parallel-controlled study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Decreased of liver fat content of fatty liver after 24 weeks treatment as assessed by B-ultrasound
time frame: up to 24 weeks
description: Change from baseline liver fat content to up to 24 weeks after treatment
measure: Change of B-cell function after 24 weeks treatment as assessed by homeostasis model assessment of insulin resistance index
time frame: up to 24 weeks
description: Change from baseline B-cell function to up to 24 weeks after treatment
measure: Change of liver enzyme after 24 weeks treatment as assessed by blood test
time frame: up to 24 weeks
description: Change from baseline liver enzyme to up to 24 weeks after treatment
measure: Decreased of HbA1c after 24 weeks treatment as assessed by blood test
time frame: up to 24 weeks
description: Change from baseline HbA1c to up to 24 weeks after treatment
measure: Decreased of fasting blood glucose after 24 weeks treatment as assessed by blood test
time frame: up to 24 weeks
description: Change from baseline fasting blood glucose to up to 24 weeks after treatment
measure: Change of weight and waistline after 24 weeks treatment as assessed by standard measurement
time frame: up to 24 weeks
description: Change from baseline weight and waistline to up to 24 weeks after treatment
arm group label: Combination of Pioglitazone and Metformin Tablets
arm group type: Experimental
description: dosage form: tablet; dosage:15mg/500mg; frequency: the dose in week 1 is 15mg/500mg, once a day, increased to 15mg/500mg in the second week, twice a day and maintain this dose to 24 weeks duration: 24 weeks; type: oral;
arm group label: Metformin Hydrochloride Tablets
arm group type: Active Comparator
description: dosage form: tablet; dosage: 850mg; frequency: the dose in week 1 is 850mg, once a day, increased to 850mg in the second week, twice a day and maintain this dose to 24 weeks duration: 24 weeks; type: oral;
intervention type: Drug
intervention name: Combination of Pioglitazone and Metformin Tablets
description: 15mg/500mg, oral, 2/day
arm group label: Combination of Pioglitazone and Metformin Tablets
other name: ka shuang ping
intervention type: Drug
intervention name: Metformin Hydrochloride Tablets
description: Oral metformin 850mg, 2/day in the control group
arm group label: Metformin Hydrochloride Tablets
other name: ge hua zhi
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Qiuhe Ph.D Ji, M.D.
role: Principal Investigator
affiliation: Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University
facility: 
country: China
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Pioglitazone
sharing ipd: Undecided