<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/NCT03006159</url>
  </required_header>
  <id_info>
    <org_study_id>SHR0534-Ib</org_study_id>
    <nct_id>NCT03006159</nct_id>
  </id_info>
  <brief_title>A Phase 1, Randomized, Placebo-controlled, Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Chinese Type 2 Diabetic Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, placebo-controlled, multiple dose escalation study to investigate the&#xD;
      safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be&#xD;
      conducted with dose of 5 mg, 10mg and 25 mg. Chinese Type 2 Diabetic patients will be&#xD;
      randomized in each cohort to receive the study drug or placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 1</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>Number of treatment emergent adverse events</measure>
    <time_frame>From baseline up to 8 days after last treatment (Day 38)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration curve after the first and last multiple oral dose (AUC)</measure>
    <time_frame>From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak plasma concentration (Cmax) after the first and last multiple oral dose</measure>
    <time_frame>From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal elimination halflife (t½) for SHR0534 after the last multiple oral dose</measure>
    <time_frame>From time 0 to 192 hours after the last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the concentrations of blood glucose and insulin after multiple oral dose</measure>
    <time_frame>From baseline up to 24 hours after last treatment (Day 31)]</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Type 2 Diabetic Patients</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 5 mg SHR0534 or matching placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 10 mg SHR0534 or matching placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 25 mg SHR0534 or matching placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHR0534</intervention_name>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes diagnosed for more than 3 months;&#xD;
&#xD;
          -  HbA1c between ≥7.0 and ≤10.5% for naive patients, or ≥6.5 and ≤9.5% for patients&#xD;
             treated with single oral drug, with FPG ≤13.9 mmol/L at randomization;&#xD;
&#xD;
          -  Body Mass Index (BMI) between 18 and 40 kg/m^2 (inclusive) with a total body weight of&#xD;
             at least 50 kg;&#xD;
&#xD;
          -  Agree to stop any other drugs for diabetes during washout and study period;&#xD;
&#xD;
          -  Serum C peptide concentration ≥0.8ng/mL at randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participated any drug clinical trials within 3 months or ≥3 times during the last&#xD;
             year, or had blood donation/loss≥400mL or as Blood recipient within 3 months before&#xD;
             randomization;&#xD;
&#xD;
          -  History use of Insulin within 6 months;&#xD;
&#xD;
          -  Drug or alcohol abuse within 6 months;&#xD;
&#xD;
          -  Use any other hypoglycemic drugs or weight reducing drugs within 3 months, or use any&#xD;
             grug or dietary supplements within 1 weeks prior to screening ;&#xD;
&#xD;
          -  Underwent surgical procedures within 1 month prior to screening, or planned major&#xD;
             surgical procedures during the study period;&#xD;
&#xD;
          -  Subject who cannot refrain from smoking, eating and/or drinking containing&#xD;
             xanthine/caffeine, or strenuous exercise, or others that affect drug absorption,&#xD;
             distribution, metabolism and excretion within 2 days before the study drug&#xD;
             administration;&#xD;
&#xD;
          -  With active hepatitis;&#xD;
&#xD;
          -  Uncontrolled endocrine system diseases (such as hyperthyroidism, hypothyroidism,&#xD;
             Cushing syndrome, multiple endocrine neoplasia);&#xD;
&#xD;
          -  Uncontrolled hypertension with systolic blood pressure (SBP) &gt; 160mmHg and / or&#xD;
             diastolic pressure (DBP) &gt; 100 mmHg after drug treatment;&#xD;
&#xD;
          -  History of recurrent severe hypoglycemia;&#xD;
&#xD;
          -  With severe chronic gastrointestinal disease (e.g., an active ulcer within 6 months)&#xD;
             or treatment that may affect drug absorption (e.g., gastrointestinal surgery);&#xD;
&#xD;
          -  With any cancer (other than skin basal cell carcinoma) that has been treated or&#xD;
             untreated within the last 5 years;&#xD;
&#xD;
          -  History of decompensated heart failure (NYHA grade III and IV), unstable angina,&#xD;
             stroke or transient ischemic attack, persistent myocardial infarction, and the&#xD;
             clinical significance of arrhythmia (such as frequent contractions), or had coronary&#xD;
             artery bypass grafting or percutaneous coronary intervention within 6 months;&#xD;
&#xD;
          -  History of acute metabolic complications, or proliferative retinopathy or maculopathy&#xD;
             which required acute treatment within 6 months;&#xD;
&#xD;
          -  Severe trauma or severe infection that may affect glycemic control within 1 months&#xD;
             before screening;&#xD;
&#xD;
          -  AST, ALT or TBIL&gt;1.5×UNL, or Cre&gt;1.5 mg/dL(male)/1.4 mg/dL(female), or ACR&gt;300mg/g at&#xD;
             screening;&#xD;
&#xD;
          -  Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or&#xD;
             syphilis antibody;&#xD;
&#xD;
          -  With clinical significance abnormal of ECGs, such as II or III degree atrioventricular&#xD;
             block (except right bundle branch block), long QT syndrome or QTc&gt;500 MS;&#xD;
&#xD;
          -  Subject was not suitable for the study as determined by the Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 28, 2016</last_update_submitted>
  <last_update_submitted_qc>December 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03006159
org study id: SHR0534-Ib
nct id: NCT03006159
lead sponsor: 
has dmc: No
This is a randomized, placebo-controlled, multiple dose escalation study to investigate the
      safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be
      conducted with dose of 5 mg, 10mg and 25 mg. Chinese Type 2 Diabetic patients will be
      randomized in each cohort to receive the study drug or placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of treatment emergent adverse events
time frame: From baseline up to 8 days after last treatment (Day 38)
measure: Area under the plasma concentration curve after the first and last multiple oral dose (AUC)
time frame: From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose
measure: Peak plasma concentration (Cmax) after the first and last multiple oral dose
time frame: From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose
measure: Terminal elimination halflife (t½) for SHR0534 after the last multiple oral dose
time frame: From time 0 to 192 hours after the last dose
measure: Changes in the concentrations of blood glucose and insulin after multiple oral dose
time frame: From baseline up to 24 hours after last treatment (Day 31)]
arm group label: Cohort 1
arm group type: Experimental
description: Twelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 5 mg SHR0534 or matching placebo.
arm group label: Cohort 2
arm group type: Experimental
description: Twelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 10 mg SHR0534 or matching placebo.
arm group label: Cohort 3
arm group type: Experimental
description: Twelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 25 mg SHR0534 or matching placebo.
intervention type: Drug
intervention name: SHR0534
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
intervention type: Drug
intervention name: Placebo
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Sponsor
sharing ipd: No