<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/NCT01680978</url>
  </required_header>
  <id_info>
    <org_study_id>BC25445</org_study_id>
    <nct_id>NCT01680978</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of Aleglitazar on Cardiac Energetics and Function in Patients With Type 2 Diabetes Mellitus and no History of Coronary Artery Disease</brief_title>
  <official_title>A SINGLE CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, CROSSOVER, PHASE II STUDY TO ASSESS THE EFFECT OF ALEGLITAZAR ON CARDIAC ENERGETICS AND FUNCTION IN PATIENTS WITH UNCOMPLICATED TYPE 2 DIABETES MELLITUS AND NO HISTORY OF CORONARY ARTERY DISEASE WHO ARE DRUG-NAÏVE OR TREATED WITH STABLE METFORMIN MONOTHERAPY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to&#xD;
      assess the effect of aleglitazar on cardiac energetics and function in patients with&#xD;
      uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are&#xD;
      drug-naïve or treated with stable metformin. Eligible patients will receive either 150 mcg&#xD;
      aleglitazar or placebo orally daily for 6 weeks. After a washout period of 6 weeks, patients&#xD;
      will cross over to the treatment not yet received.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac energetics: Change in PCr/ATP ratio using phosphorus magnetic resonance spectroscopy (MRS)</measure>
    <time_frame>from baseline to Week 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in left ventricular diastolic function measured by mitral inflow, tissue Doppler Imaging and magnetic resonance imaging (MRI)</measure>
    <time_frame>from baseline to Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiac/hepatic triglyceride content assessed my MRS</measure>
    <time_frame>from baseline to Week 6</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Diabetes Mellitus Type 2</condition>
  <arm_group>
    <arm_group_label>Aleglitazar</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>aleglitazar</intervention_name>
    <description>150 mcg orally daily, 6 weeks</description>
    <arm_group_label>Aleglitazar</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>orally daily, 6 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, 40 to 70 years of age (inclusive) at screening&#xD;
&#xD;
          -  Patients with Type 2 diabetes mellitus diagnosed at least 12 weeks before screening&#xD;
             and either drug-naïve or treated with stable metformin monotherapy for at least 12&#xD;
             weeks prior to screening&#xD;
&#xD;
          -  HbA1c &gt;/= 7 % and &lt;/= 9% at screening&#xD;
&#xD;
          -  Absence of history of coronary artery disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis or history of Type 1 diabetes mellitus, diabetes resulting from pancreatic&#xD;
             injury, or secondary forms of diabetes&#xD;
&#xD;
          -  Current treatment with fibrates, thiazolidinediones, or insulin&#xD;
&#xD;
          -  Prior intolerance to thiazolidinediones and/or fibrates&#xD;
&#xD;
          -  Clinically significant liver disease or impaired liver function&#xD;
&#xD;
          -  Know chronic diabetic complications (i.e. retinopathy, neuropathy, nephropathy)&#xD;
&#xD;
          -  Symptomatic congestive heart failure classified as NYHA class II-IV&#xD;
&#xD;
          -  Diagnosed and/or treated malignancy within the past 5 years, except for treated basal&#xD;
             cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer&#xD;
&#xD;
          -  Contraindications to MRI, or inability to tolerate MRI scanning&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2016</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>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <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>


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/NCT01680978
org study id: BC25445
nct id: NCT01680978
lead sponsor: 
A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to
      assess the effect of aleglitazar on cardiac energetics and function in patients with
      uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are
      drug-naïve or treated with stable metformin. Eligible patients will receive either 150 mcg
      aleglitazar or placebo orally daily for 6 weeks. After a washout period of 6 weeks, patients
      will cross over to the treatment not yet received.
intervention model: Crossover Assignment
masking: Double (Participant, Investigator)
measure: Cardiac energetics: Change in PCr/ATP ratio using phosphorus magnetic resonance spectroscopy (MRS)
time frame: from baseline to Week 6
measure: Change in left ventricular diastolic function measured by mitral inflow, tissue Doppler Imaging and magnetic resonance imaging (MRI)
time frame: from baseline to Week 6
measure: Change in cardiac/hepatic triglyceride content assessed my MRS
time frame: from baseline to Week 6
arm group label: Aleglitazar
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: aleglitazar
description: 150 mcg orally daily, 6 weeks
arm group label: Aleglitazar
intervention type: Drug
intervention name: placebo
description: orally daily, 6 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2