xml: <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/NCT06007014</url>
    </required_header>
    <id_info>
      <org_study_id>HLi</org_study_id>
      <nct_id>NCT06007014</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Chiglitazar Added to Glargine in Patients With Type 2 Diabetes</brief_title>
    <official_title>A Multi-Center, Randomised, Double-blind, Placebo Parallel Controlled Clinical Study to Evaluate the Efficacy and Safety of Chiglitazar Added to Glargine in Patients With Type 2 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yanbing Li</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen University</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this clinical trial is to evaluate the Efficacy and Safety of Chiglitazar Added&#xD;
        to Patients with type 2 diabetes who do not respond well to metformin combined with insulin&#xD;
        glargine. The main question it aims to answer are:&#xD;
  &#xD;
        • T2DM patients still cannot effectively control their blood sugar with the combination of&#xD;
        insulin and metformin. The combination of follow-up treatment and hypoglycemic drugs is worth&#xD;
        exploring, and it is necessary to explore and confirm the combination of effective and safe&#xD;
        drugs for insulin resistance on the basis of the above treatment plans.&#xD;
  &#xD;
        Participants will be asked to receive either Chiglitazar or placebo in addition to metformin&#xD;
        and insulin glargine 18 weeks.&#xD;
  &#xD;
        Researchers will compare placebo groups to see if the effective effect and safety indicators&#xD;
        of Chiglitazar for reducing insulin dosage, lowering blood sugar, regulating blood lipids.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        T2DM patients using insulin combined with metformin dual therapy regimen, still can not have&#xD;
        effective control of blood sugar, the combination of follow-up treatment and hypoglycemic&#xD;
        drugs is worth exploring, and it is necessary to base on the above treatment plans to explore&#xD;
        and confirm the treatment of effective and safe drugs for insulin resistance. This study&#xD;
        investigated the efficacy and safety of metformin combined with insulin glargine in the&#xD;
        treatment of type 2 diabetes mellitus (T2DM) in patients who still have poor hypoglycemic&#xD;
        effect, plus Chiglitazar 48mg/ day for 18 weeks.&#xD;
  &#xD;
        A total of 128 patients were expected to be included, and were randomly assigned 1:1 to the&#xD;
        combination of metformin and insulin glargine combined with Chiglitazar sodium tablet 48mg/&#xD;
        day group. Metformin and insulin glargine combined with placebo group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2025</primary_completion_date>
    <phase>N/A</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>
      <intervention_model_description>Metformin and insulin glargine combined with Chiglitazar sodium tablets 48mg/ day group；Metformin and insulin glargine combined with placebo group.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>HbA1C</measure>
      <time_frame>18 weeks of treatment</time_frame>
      <description>Changes in HbA1C from baseline</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Insulin</measure>
      <time_frame>6 weeks and 18 weeks of treatment</time_frame>
      <description>Changes in the daily dose of insulin from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Triglyceride</measure>
      <time_frame>18 weeks of treatment</time_frame>
      <description>Changes in the daily dose of triglyceride from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fasting blood glucose</measure>
      <time_frame>6 weeks and 18 weeks of treatment</time_frame>
      <description>Changes in the daily dose of fasting blood glucose from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fasting C-Peptide</measure>
      <time_frame>18 weeks of treatment</time_frame>
      <description>Changes in the daily dose of fasting C-Peptide from baseline</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">128</enrollment>
    <condition>Efficacy and Safety of Chiglitazar Sodium in the Treatment of T2DM Patients</condition>
    <condition>Metformin Combined With Insulin Glargine in the Treatment of Type 2 Diabetes Patients Who Still Have Poor Hypoglycemic Effect</condition>
    <condition>128 Patients Were Randomly Assigned 1:1</condition>
    <condition>Metformin and Insulin Glargine Combined With Chiglitazar Sodium Tablets 48mg/ Day Group</condition>
    <condition>Metformin and Insulin Glargine Combined With Placebo Group</condition>
    <condition>InvestigatorInitiate Trial</condition>
    <condition>Changes in HbA1C From Baseline at 18 Weeks of Treatment</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Metformin and insulin glargine combined with sitaglitat sodium tablets 48mg/ day group;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Metformin and insulin glargine combined with placebo group</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Chiglitazar sodium</intervention_name>
      <description>tablets 48mg/ day administered for 18 weeks</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Chiglitazar placebo</intervention_name>
      <description>tablets 48mg/ day administered for 18 weeks</description>
      <arm_group_label>Placebo group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1.In accordance with the World Health Organization (WHO) issued in 1999 diabetes&#xD;
               diagnostic criteriaType 2 diabetes mellitus (T2DM);&#xD;
  &#xD;
            -  2. Male or female patients ≥18 years old;&#xD;
  &#xD;
            -  3, BMI≥18.5 Kg/m2, &lt; 35 Kg/m2;&#xD;
  &#xD;
            -  4, Glycosylated hemoglobin (HbA1C) &gt; 7.5%; ≤10.5%;&#xD;
  &#xD;
            -  5, Stable dose (insulin daily therapeutic dose change within ±20%) of glycerine or DI&#xD;
               The therapeutic dose of Terterigu or NPH basal insulin is ≥0.25IU/kg/ day/or 20IU/&#xD;
               day；&#xD;
  &#xD;
            -  6, Stable basic insulin treatment combined with metformin (metformin dose ≥1000mg/Days&#xD;
               or maximum tolerated dose) ≥3 months；&#xD;
  &#xD;
            -  7. Voluntarily sign informed consent and agree to be randomly assigned to any&#xD;
               experimental group.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1, Type 1 diabetes or specific type diabetes;&#xD;
  &#xD;
            -  2. Fasting blood glucose (FPG) exceeding 13.3 mmol/L (240 mg/dL);&#xD;
  &#xD;
            -  3, refractory hypertension [that is, on the basis of improving lifestyle, the&#xD;
               application of a reasonable and tolerable sufficient amount of 3 or more&#xD;
               antihypertensive drugs (including diuretics) for more than 1 month still does not&#xD;
               reach the standard, or take 4 or more antihypertensive drugs to effectively control&#xD;
               blood pressure];&#xD;
  &#xD;
            -  4. Triglyceride (TG) &gt; 500 mg /dL (5.65 mmol/L);&#xD;
  &#xD;
            -  5, is taking or in the last 1 month has taken fibrate drug treatment;&#xD;
  &#xD;
            -  6, lower limb edema or general edema;&#xD;
  &#xD;
            -  7. Experienced 3 or more episodes of severe hypoglycemia and/or unintentional&#xD;
               hypoglycemia in the 6 months prior to screening;&#xD;
  &#xD;
            -  8. A definite diagnosis of osteoporosis or any other known bone disease;&#xD;
  &#xD;
            -  9. History of diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome,&#xD;
               lactic acidosis and other acute complications of diabetes;&#xD;
  &#xD;
            -  10. Severe microvascular complications (proliferative retinopathy; Urinary&#xD;
               albumin/creatinine ratio &amp;gt; 300 mg/g; Marked peripheral neuropathy, etc.);&#xD;
  &#xD;
            -  11. Large vascular lesions leading to hospital admission within 6 months before&#xD;
               inclusion;&#xD;
  &#xD;
            -  12, The New York Heart Association (NYHA) defines congestive heart failure as grade&#xD;
               III or IV&#xD;
  &#xD;
            -  13, significant liver and kidney dysfunction and systemic disease (significant liver&#xD;
               dysfunction is defined as AST&amp;gt; 2.5 times the upper limit of normal and/or ALT&amp;gt;&#xD;
               2.5 times the upper limit of normal and/or total bilirubin &amp;gt; 1.5 times the upper&#xD;
               limit of normal value; Renal dysfunction was defined as moderate to severe renal&#xD;
               insufficiency (eGFR&amp;lt;60 ml/ (min*1.73m2)).&#xD;
  &#xD;
            -  14. Use of other hypoglycemic agents not specified in the inclusion criteria&#xD;
               (thiazolidinediones, GLP-1RA, premixed or fast-acting insulin) in the current or 3&#xD;
               months prior to screening, with the exception of short-term treatment with additional&#xD;
               insulin (a total of 7 days or less) for complications;&#xD;
  &#xD;
            -  15, pregnant or lactating women, women of childbearing age who are unable or unwilling&#xD;
               to take adequate contraception;&#xD;
  &#xD;
            -  16. Participating in clinical trials of other drugs or medical devices during or&#xD;
               within 3 months prior to screening;&#xD;
  &#xD;
            -  17. The investigator considers it inappropriate to participate in this clinical trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>the First Affiliated Hospital of Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Yanbing Li</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Chiglitazar</keyword>
    <keyword>T2DM</keyword>
    <keyword>Randomised</keyword>
    <keyword>Double-blind</keyword>
    <keyword>Placebo Parallel Controlled</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 2</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007014
  org study id: HLi
  nct id: NCT06007014
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the Efficacy and Safety of Chiglitazar Added
        to Patients with type 2 diabetes who do not respond well to metformin combined with insulin
        glargine. The main question it aims to answer are:
  
        • T2DM patients still cannot effectively control their blood sugar with the combination of
        insulin and metformin. The combination of follow-up treatment and hypoglycemic drugs is worth
        exploring, and it is necessary to explore and confirm the combination of effective and safe
        drugs for insulin resistance on the basis of the above treatment plans.
  
        Participants will be asked to receive either Chiglitazar or placebo in addition to metformin
        and insulin glargine 18 weeks.
  
        Researchers will compare placebo groups to see if the effective effect and safety indicators
        of Chiglitazar for reducing insulin dosage, lowering blood sugar, regulating blood lipids.
  T2DM patients using insulin combined with metformin dual therapy regimen, still can not have
        effective control of blood sugar, the combination of follow-up treatment and hypoglycemic
        drugs is worth exploring, and it is necessary to base on the above treatment plans to explore
        and confirm the treatment of effective and safe drugs for insulin resistance. This study
        investigated the efficacy and safety of metformin combined with insulin glargine in the
        treatment of type 2 diabetes mellitus (T2DM) in patients who still have poor hypoglycemic
        effect, plus Chiglitazar 48mg/ day for 18 weeks.
  
        A total of 128 patients were expected to be included, and were randomly assigned 1:1 to the
        combination of metformin and insulin glargine combined with Chiglitazar sodium tablet 48mg/
        day group. Metformin and insulin glargine combined with placebo group.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Metformin and insulin glargine combined with Chiglitazar sodium tablets 48mg/ day group；Metformin and insulin glargine combined with placebo group.
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: HbA1C
  time frame: 18 weeks of treatment
  description: Changes in HbA1C from baseline
  measure: Insulin
  time frame: 6 weeks and 18 weeks of treatment
  description: Changes in the daily dose of insulin from baseline
  measure: Triglyceride
  time frame: 18 weeks of treatment
  description: Changes in the daily dose of triglyceride from baseline
  measure: Fasting blood glucose
  time frame: 6 weeks and 18 weeks of treatment
  description: Changes in the daily dose of fasting blood glucose from baseline
  measure: Fasting C-Peptide
  time frame: 18 weeks of treatment
  description: Changes in the daily dose of fasting C-Peptide from baseline
  arm group label: Intervention group
  arm group type: Experimental
  description: Metformin and insulin glargine combined with sitaglitat sodium tablets 48mg/ day group;
  arm group label: Placebo group
  arm group type: Placebo Comparator
  description: Metformin and insulin glargine combined with placebo group
  intervention type: Drug
  intervention name: Chiglitazar sodium
  description: tablets 48mg/ day administered for 18 weeks
  arm group label: Intervention group
  intervention type: Drug
  intervention name: Chiglitazar placebo
  description: tablets 48mg/ day administered for 18 weeks
  arm group label: Placebo group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Yanbing Li
  investigator title: Professor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2