<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/NCT03039075</url>
  </required_header>
  <id_info>
    <org_study_id>CQ-Metformin-2016</org_study_id>
    <nct_id>NCT03039075</nct_id>
  </id_info>
  <brief_title>Metformin SR Tablet (DuLeNing) and Glucophage in Patients With Type 2 Diabetes</brief_title>
  <acronym>CQM-2016</acronym>
  <official_title>Comparison of Metformin Hydrochloride Sustained-release Tablet (DuLeNing) and Glucophage in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chongqing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD is&#xD;
      approved by China Food And Drug Administration (cFDA). Whether its efficacy and safety are&#xD;
      equal to Glucophage is unclear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To perform a RCT for the comparison between Metformin hydrochloride sustained-release tablets&#xD;
      made in Conquer pharmaceutical co., LTD and Glucophage .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</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>Changes of HbA1c</measure>
    <time_frame>12 weeks</time_frame>
    <description>Efficacy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of nausea, diarrhea</measure>
    <time_frame>12 weeks</time_frame>
    <description>Safety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of weight</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of intestinal flora proportion</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of LDL, HDL, TG, TC</measure>
    <time_frame>12 weeks</time_frame>
    <description>blood lipid</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Metformin SR Tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucophage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The original drug of metformin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin SR Tablet</intervention_name>
    <description>Metformin SR Tablet made in Conquer pharmaceutical co., LTD</description>
    <arm_group_label>Glucophage</arm_group_label>
    <arm_group_label>Metformin SR Tablet</arm_group_label>
    <other_name>DuLeNing</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Well informed of the procedures of this trial and informed consent is obtained&#xD;
&#xD;
          2. Voluntarily accept standardized treatment 3.18-75 years old, gender is not limited&#xD;
&#xD;
        4.Newly diagnosed as type 2 diabetes and have not yet received any hypoglycemic therapy&#xD;
        5.Unable to control the blood glucose by diet and exercise: 7.5% ≤HbA1c ≤11.0%, in&#xD;
        screening and before randomization 6.BMI: 19~35 kg/m2 7.Well compliance 8.Capable of self&#xD;
        blood Glucose monitoring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating&#xD;
&#xD;
          2. Type 1 diabetes&#xD;
&#xD;
          3. Poor blood glucose control（HbA1c&gt;11%）&#xD;
&#xD;
          4. A history of malignant tumor&#xD;
&#xD;
          5. Abnormal liver or renal function (defined as alanine aminotransferase(ALT)&gt;2.5 times&#xD;
             higher than normal range,or eGFR&lt;45 mL/min per 1•73 m²)&#xD;
&#xD;
          6. Poor blood pressure control [systolic blood pressure(SBP)&gt;180mmHg,or diastolic blood&#xD;
             pressure(DBP)&gt;110mmHg]&#xD;
&#xD;
          7. With severe heart disease,cardiac function worse than grade II,anemia(Hb&lt;9.0g/d1)&#xD;
&#xD;
          8. Continuous use of antidiabetic drugs more than one week in recent 3 months&#xD;
&#xD;
          9. History of acute metabolic complications in recent 6 months&#xD;
&#xD;
         10. Blood routine test indicates that the white blood cell count(WBC) &lt;3*109/l&#xD;
&#xD;
         11. Body Mass Index(BMI)&lt;18.5 or ≥35kg/m2&#xD;
&#xD;
         12. Drug or alcohol abuse&#xD;
&#xD;
         13. Accompanying mental disorder who can't collaborate&#xD;
&#xD;
         14. Abnormal digestion and absorption function&#xD;
&#xD;
         15. Other endocrine diseases&#xD;
&#xD;
         16. Other chronic diseases needed long-term glucocorticoid treatment&#xD;
&#xD;
         17. With severe infection, immune dysfunction&#xD;
&#xD;
         18. A history of metformin allergies or allergic constitution&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qifu Li, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Chongqing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Buse JB, DeFronzo RA, Rosenstock J, Kim T, Burns C, Skare S, Baron A, Fineman M. The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-term Pharmacokinetic and 12-Week Dose-Ranging Studies. Diabetes Care. 2016 Feb;39(2):198-205. doi: 10.2337/dc15-0488. Epub 2015 Aug 18.</citation>
    <PMID>26285584</PMID>
  </reference>
  <reference>
    <citation>Xu T, Brandmaier S, Messias AC, Herder C, Draisma HH, Demirkan A, Yu Z, Ried JS, Haller T, Heier M, Campillos M, Fobo G, Stark R, Holzapfel C, Adam J, Chi S, Rotter M, Panni T, Quante AS, He Y, Prehn C, Roemisch-Margl W, Kastenmuller G, Willemsen G, Pool R, Kasa K, van Dijk KW, Hankemeier T, Meisinger C, Thorand B, Ruepp A, Hrabe de Angelis M, Li Y, Wichmann HE, Stratmann B, Strauch K, Metspalu A, Gieger C, Suhre K, Adamski J, Illig T, Rathmann W, Roden M, Peters A, van Duijn CM, Boomsma DI, Meitinger T, Wang-Sattler R. Effects of metformin on metabolite profiles and LDL cholesterol in patients with type 2 diabetes. Diabetes Care. 2015 Oct;38(10):1858-67. doi: 10.2337/dc15-0658. Epub 2015 Aug 5.</citation>
    <PMID>26251408</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chongqing Medical University</investigator_affiliation>
    <investigator_full_name>Qifu Li</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03039075
org study id: CQ-Metformin-2016
nct id: NCT03039075
lead sponsor: 
has dmc: Yes
Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD is
      approved by China Food And Drug Administration (cFDA). Whether its efficacy and safety are
      equal to Glucophage is unclear.
To perform a RCT for the comparison between Metformin hydrochloride sustained-release tablets
      made in Conquer pharmaceutical co., LTD and Glucophage .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes of HbA1c
time frame: 12 weeks
description: Efficacy
measure: Incidence of nausea, diarrhea
time frame: 12 weeks
description: Safety
measure: Changes of weight
time frame: 12 weeks
measure: Changes of intestinal flora proportion
time frame: 12 weeks
measure: Changes of LDL, HDL, TG, TC
time frame: 12 weeks
description: blood lipid
arm group label: Metformin SR Tablet
arm group type: Active Comparator
description: Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD
arm group label: Glucophage
arm group type: Active Comparator
description: The original drug of metformin
intervention type: Drug
intervention name: Metformin SR Tablet
description: Metformin SR Tablet made in Conquer pharmaceutical co., LTD
arm group label: Glucophage
arm group label: Metformin SR Tablet
other name: DuLeNing
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Qifu Li, phD
role: Principal Investigator
affiliation: First Affiliated Hospital of Chongqing Medical University
facility: 
country: China
citation: Buse JB, DeFronzo RA, Rosenstock J, Kim T, Burns C, Skare S, Baron A, Fineman M. The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-term Pharmacokinetic and 12-Week Dose-Ranging Studies. Diabetes Care. 2016 Feb;39(2):198-205. doi: 10.2337/dc15-0488. Epub 2015 Aug 18.
PMID: 26285584
citation: Xu T, Brandmaier S, Messias AC, Herder C, Draisma HH, Demirkan A, Yu Z, Ried JS, Haller T, Heier M, Campillos M, Fobo G, Stark R, Holzapfel C, Adam J, Chi S, Rotter M, Panni T, Quante AS, He Y, Prehn C, Roemisch-Margl W, Kastenmuller G, Willemsen G, Pool R, Kasa K, van Dijk KW, Hankemeier T, Meisinger C, Thorand B, Ruepp A, Hrabe de Angelis M, Li Y, Wichmann HE, Stratmann B, Strauch K, Metspalu A, Gieger C, Suhre K, Adamski J, Illig T, Rathmann W, Roden M, Peters A, van Duijn CM, Boomsma DI, Meitinger T, Wang-Sattler R. Effects of metformin on metabolite profiles and LDL cholesterol in patients with type 2 diabetes. Diabetes Care. 2015 Oct;38(10):1858-67. doi: 10.2337/dc15-0658. Epub 2015 Aug 5.
PMID: 26251408
responsible party type: Principal Investigator
investigator affiliation: Chongqing Medical University
investigator full name: Qifu Li
investigator title: Primary Investigator
mesh term: Diabetes Mellitus
mesh term: Metformin
sharing ipd: No