<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/NCT03790787</url>
  </required_header>
  <id_info>
    <org_study_id>HMM0112</org_study_id>
    <nct_id>NCT03790787</nct_id>
  </id_info>
  <brief_title>Drug Interaction Study Between Dorzagliatin and Empagliflozin</brief_title>
  <official_title>A Phase 1, Open-Label, Sequential, Multiple-Dose, Drug-Drug Interaction Study of Dorzagliatin and Empagliflozin in Subjects With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hua Medicine Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hua Medicine Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of&#xD;
      glucokinase activator dorzagliatin and empagliflozin in subjects with T2DM. Pharmacokinetics&#xD;
      and pharmacodynamics when dorzagliatin and empagliflozin given alone and in combination will&#xD;
      be studied.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 18, 2019</start_date>
  <completion_date type="Actual">March 15, 2020</completion_date>
  <primary_completion_date type="Actual">March 15, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax,ss</measure>
    <time_frame>up to 5 days</time_frame>
    <description>maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCτ,ss</measure>
    <time_frame>up to 5 days</time_frame>
    <description>area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Patients</condition>
  <arm_group>
    <arm_group_label>Sequential arm ABC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A: Empagliflozin 25 mg QD in the morning on Days 1-5; B: Empagliflozin 25 mg in the morning and Dorzagliatin 75 mg BID (morning and evening) on Days 6-10, with only the morning dose on Day 10; C: Dorzagliatin 75 mg BID (morning and evening) on Days 11-15, with only the morning dose on Day 15.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin</intervention_name>
    <description>Empagliflozin as Jardiance® 25 mg film-coated tablets for oral administration</description>
    <arm_group_label>Sequential arm ABC</arm_group_label>
    <other_name>Jardiance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dorzagliatin</intervention_name>
    <description>Glucokinase activator currently under development</description>
    <arm_group_label>Sequential arm ABC</arm_group_label>
    <other_name>HMS5552</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects diagnosed with T2DM within at least 3 months prior to screening&#xD;
&#xD;
          2. Male and/or female subjects between the ages of 30 and 65 years, inclusive;&#xD;
&#xD;
          3. Body Mass Index (BMI) of 19 to 38 kg/m2, inclusive, at screening;&#xD;
&#xD;
          4. Fasting C-peptide test result &gt;0.3 nmol/L (&gt;0.90 ng/mL);&#xD;
&#xD;
          5. HbA1c ≥7% and ≤10.5%;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL ;&#xD;
&#xD;
          2. Type 1 diabetes mellitus;&#xD;
&#xD;
          3. Reported incidence of severe hypoglycemia within 3 months prior to screening;&#xD;
&#xD;
          4. Known contraindications to empagliflozin;&#xD;
&#xD;
          5. Clinically significant gastrointestinal disorder;&#xD;
&#xD;
          6. History or symptoms of clinically significant cardiovascular disease;&#xD;
&#xD;
          7. History of more than three urinary tract infections and/or more than three genital&#xD;
             fungal infections in the last 12 months;&#xD;
&#xD;
          8. Reported history of clinically significant central nervous system disease including&#xD;
             within one year prior to screening;&#xD;
&#xD;
          9. Reported history of liver disease;&#xD;
&#xD;
         10. Reported history of clinically significant renal disease;&#xD;
&#xD;
         11. Estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2;&#xD;
&#xD;
         12. Acute or chronic metabolic acidosis, including diabetic ketoacidosis;&#xD;
&#xD;
         13. Known or suspected malignancy;&#xD;
&#xD;
         14. Any reported hypersensitivity or intolerance to empagliflozin;&#xD;
&#xD;
         15. Antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or GLP-1&#xD;
             agonist within 3 months prior to screening;&#xD;
&#xD;
         16. Systolic blood pressure &lt;90 or &gt;160 mmHg or diastolic blood pressure &lt;60 or &gt;100 mmHg&#xD;
             at screening;&#xD;
&#xD;
         17. A hospital admission or major surgery within 90 days prior to screening;&#xD;
&#xD;
         18. Uncontrolled hypertriglyceridemia &gt;500 mg/dL;&#xD;
&#xD;
         19. Positive blood screen for HIV, HBsAg, or hepatitis C antibody;&#xD;
&#xD;
         20. Positive pregnancy test result;&#xD;
&#xD;
         21. Treated with any investigational drugs within 6 weeks prior to screening;&#xD;
&#xD;
         22. Reported history of prescription drug abuse;&#xD;
&#xD;
         23. Reported history of alcohol abuse&#xD;
&#xD;
         24. Reported history of donation or acute loss of blood during the 90 days prior to&#xD;
             screening;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory J Tracey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Frontage Clinical Services, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Frontage Clinical Services Inc.</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Empagliflozin</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/NCT03790787
org study id: HMM0112
nct id: NCT03790787
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of
      glucokinase activator dorzagliatin and empagliflozin in subjects with T2DM. Pharmacokinetics
      and pharmacodynamics when dorzagliatin and empagliflozin given alone and in combination will
      be studied.
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax,ss
time frame: up to 5 days
description: maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
measure: AUCτ,ss
time frame: up to 5 days
description: area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ
arm group label: Sequential arm ABC
arm group type: Experimental
description: A: Empagliflozin 25 mg QD in the morning on Days 1-5; B: Empagliflozin 25 mg in the morning and Dorzagliatin 75 mg BID (morning and evening) on Days 6-10, with only the morning dose on Day 10; C: Dorzagliatin 75 mg BID (morning and evening) on Days 11-15, with only the morning dose on Day 15.
intervention type: Drug
intervention name: Empagliflozin
description: Empagliflozin as Jardiance® 25 mg film-coated tablets for oral administration
arm group label: Sequential arm ABC
other name: Jardiance
intervention type: Drug
intervention name: Dorzagliatin
description: Glucokinase activator currently under development
arm group label: Sequential arm ABC
other name: HMS5552
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Gregory J Tracey, MD
role: Principal Investigator
affiliation: Frontage Clinical Services, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Empagliflozin
sharing ipd: No