<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/NCT01728467</url>
  </required_header>
  <id_info>
    <org_study_id>RVX222-CS-010</org_study_id>
    <secondary_id>Alfred Study No. 409/12</secondary_id>
    <nct_id>NCT01728467</nct_id>
  </id_info>
  <brief_title>The Effects of RVX000222 on Glucose Metabolism in Individuals With Pre-diabetes</brief_title>
  <official_title>Phase 2 Randomised, Double-blind, Placebo-controlled, Cross-over Study for the Assessment of Glucose Metabolism Changes With RVX000222 in Individuals With Pre-diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Resverlogix Corp</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baker Heart and Diabetes Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nucleus Network Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Resverlogix Corp</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study builds on data that high-density lipoprotein (HDL) has a number of potentially&#xD;
      beneficial effects including directly modulating glucose metabolism through multiple&#xD;
      mechanisms. The primary objective of this study is to determine the effects of RVX000222 on&#xD;
      postprandial plasma glucose in male individuals with impaired fasting glucose (IFG) or&#xD;
      impaired glucose tolerance (IGT), during a frequently sampled oral glucose tolerance test&#xD;
      (OGTT).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in plasma glucose following treatment with RVX000222 compared to placebo</measure>
    <time_frame>29-33 days</time_frame>
    <description>The change in postprandial plasma glucose, defined as area under the glucose curve (AUGC) during a frequently sampled OGTT following RVX000222 treatment for 29-33 days as compared to placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in insulin secretion and insulin sensitivity following treatment with RVX000222 compared to placebo</measure>
    <time_frame>29-33 days</time_frame>
    <description>The change in indices of insulin secretion (β-cell function) and insulin sensitivity during a frequently sampled OGTT following RVX000222 treatment for 29-33 days as compared to placebo.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>RVX000222, 200 mg daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RVX000222</intervention_name>
    <description>capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 31-35 days</description>
    <arm_group_label>RVX000222, 200 mg daily</arm_group_label>
    <other_name>RVX-208</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo, RVX000222</intervention_name>
    <description>capsule, administer with food, twice daily 10-12 hrs apart, 31-35 days</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males aged 18-70 years, inclusive&#xD;
&#xD;
          -  Body mass index (BMI): 25-40 kg/m2&#xD;
&#xD;
          -  HDL cholesterol plasma levels: ≤1.4 mmol/L&#xD;
&#xD;
          -  Pre-diabetes: Either impaired fasting glucose (IFG; 6.1-6.9mmol/L) or impaired glucose&#xD;
             tolerance (IGT; 2 hour OGTT glucose 7.8-11.0mmol/L, WHO classification) as measured at&#xD;
             Visit 1&#xD;
&#xD;
          -  No current use or need for prescription or over-the-counter medication within four&#xD;
             days of Visit 1&#xD;
&#xD;
          -  Have given signed informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Identification of any other medical condition requiring immediate therapeutic&#xD;
             intervention&#xD;
&#xD;
          -  Has received any over-the-counter medication including vitamins, herbal, or dietary&#xD;
             supplements within four days of Visit 1 unless prior approval from the Investigator&#xD;
&#xD;
          -  Tobacco use within six months of Visit 1 (including cigarettes, pipes, chewing&#xD;
             tobacco)&#xD;
&#xD;
          -  Elective surgery requiring general anaesthesia during the course of the study&#xD;
&#xD;
          -  Clinically significant heart disease at Visit 1&#xD;
&#xD;
          -  Clinically significant abnormal ECG at Visit 1&#xD;
&#xD;
          -  Evidence of renal impairment defined as serum creatinine &gt;1.5 mg/dL (133 μmol/L) or&#xD;
             creatinine clearance of &lt;60 mL/min&#xD;
&#xD;
          -  History of hypertension or supine SBP &gt;160mmHg or DBP &gt;95mmHg as measured at Visit 1&#xD;
&#xD;
          -  Evidence of type 2 diabetes (fasting plasma glucose ≥7.0mmol/L; 2 hour OGTT glucose&#xD;
             ≥11.1mmol/L)&#xD;
&#xD;
          -  Evidence of liver disease defined as aspartate aminotransferase (AST), alanine&#xD;
             aminotransferase (ALT) or total bilirubin &gt;1.5 x upper limit of normal (ULN) at Visit&#xD;
             1&#xD;
&#xD;
          -  History of malignancy within past 5 years&#xD;
&#xD;
          -  History or evidence of drug or alcohol abuse within 12 months of Visit 1&#xD;
&#xD;
          -  Use of other investigational drugs and/or devices at the time of enrolment, or within&#xD;
             30 days of Visit 1&#xD;
&#xD;
          -  History of non-compliance to medical regimens or unwillingness to comply with the&#xD;
             study protocol&#xD;
&#xD;
          -  Any condition that in the opinion of the Investigators would confound the evaluation&#xD;
             and interpretation of the data&#xD;
&#xD;
          -  Persons directly involved in the execution of the protocol&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Professor Bronwyn Kingwell</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baker Heart and Diabetes Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Stephen Duffy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baker Heart and Diabetes Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baker IDI Heart and Diabetes Institute 75 Commercial Road,</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <last_update_submitted>March 31, 2014</last_update_submitted>
  <last_update_submitted_qc>March 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <!-- 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/NCT01728467
org study id: RVX222-CS-010
secondary id: Alfred Study No. 409/12
nct id: NCT01728467
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study builds on data that high-density lipoprotein (HDL) has a number of potentially
      beneficial effects including directly modulating glucose metabolism through multiple
      mechanisms. The primary objective of this study is to determine the effects of RVX000222 on
      postprandial plasma glucose in male individuals with impaired fasting glucose (IFG) or
      impaired glucose tolerance (IGT), during a frequently sampled oral glucose tolerance test
      (OGTT).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in plasma glucose following treatment with RVX000222 compared to placebo
time frame: 29-33 days
description: The change in postprandial plasma glucose, defined as area under the glucose curve (AUGC) during a frequently sampled OGTT following RVX000222 treatment for 29-33 days as compared to placebo.
measure: Change in insulin secretion and insulin sensitivity following treatment with RVX000222 compared to placebo
time frame: 29-33 days
description: The change in indices of insulin secretion (β-cell function) and insulin sensitivity during a frequently sampled OGTT following RVX000222 treatment for 29-33 days as compared to placebo.
arm group label: RVX000222, 200 mg daily
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: RVX000222
description: capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 31-35 days
arm group label: RVX000222, 200 mg daily
other name: RVX-208
intervention type: Drug
intervention name: Placebo, RVX000222
description: capsule, administer with food, twice daily 10-12 hrs apart, 31-35 days
arm group label: Placebo
other name: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Professor Bronwyn Kingwell
role: Principal Investigator
affiliation: Baker Heart and Diabetes Institute
last name: Dr. Stephen Duffy
role: Principal Investigator
affiliation: Baker Heart and Diabetes Institute
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Prediabetic State