<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/NCT01691989</url>
  </required_header>
  <id_info>
    <org_study_id>WC28325</org_study_id>
    <nct_id>NCT01691989</nct_id>
  </id_info>
  <brief_title>A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy</brief_title>
  <official_title>A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PHASE III STUDY TO ASSESS THE EFFICACY,SAFETY AND TOLERABILITY OF ALEGLITAZAR ADDED TO A SU OR ADDED TO A SU IN COMBINATION WITH MET IN PATIENTS WITH T2D INADEQUATELY CONTROLLED WITH SU MONOTHERAPY OR WITH SU + METFORMIN COMBINATION THERAPY</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>
      This multicenter, randomized, double-blind, placebo-controlled study will assess the&#xD;
      efficacy, safety and tolerability of aleglitazar compared with placebo when added to a&#xD;
      sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with&#xD;
      type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or&#xD;
      sulfonylurea plus metformin therapy. Patients will be randomized to receive oral doses of 150&#xD;
      mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in hemoglobin HbA1c</measure>
    <time_frame>From baseline to week 26</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in lipid profile</measure>
    <time_frame>From baseline to week 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting plasma glucose</measure>
    <time_frame>From baseline to week 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder rate as defined of hemoglobin HbAc1 &lt;7.0% (&lt;6.5%)</measure>
    <time_frame>From baseline to week 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)</measure>
    <time_frame>From baseline to week 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in markers of insulin sensitivity and cardiovascular risk</measure>
    <time_frame>From baseline to week 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: incidence of adverse events</measure>
    <time_frame>30 weeks (26 weeks treatment and 4 weeks follow-up)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">197</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>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aleglitazar</intervention_name>
    <description>150 mcg orally once a day for 26 weeks</description>
    <arm_group_label>aleglitazar</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>oral doses once a day for 26 weeks</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/=18 years of age&#xD;
&#xD;
          -  Diagnosis of diabetes mellitus, type 2&#xD;
&#xD;
          -  Patients treated with stable sulfonylurea monotherapy or sulfonylurea plus metformin&#xD;
             combination therapy for at least 12 weeks prior to screening&#xD;
&#xD;
          -  HbA1c &gt;/=7% and &lt;/=9.5% at screening or within 4 weeks prior to screening and at&#xD;
             pre-randomization visit&#xD;
&#xD;
          -  Fasting plasma glucose &lt;/=240 mg/dL at pre-randomization visit&#xD;
&#xD;
          -  Agreement to maintain diet and exercise habits during the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from&#xD;
             pancreatic injury, or acute metabolic diabetic complications within the past 6 months&#xD;
&#xD;
          -  Any previous treatment with thiazolidinedione or a dual PPAR agonist&#xD;
&#xD;
          -  Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to&#xD;
             screening (except stable dose of statin)&#xD;
&#xD;
          -  Any anti-hyperglycemic medication other than sulfonylurea alone or in combination with&#xD;
             metformin within 12 weeks prior to screening&#xD;
&#xD;
          -  Symptomatic congestive heart failure classified as New York Heart Association class&#xD;
             II-IV at screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>Chino</city>
        <state>California</state>
        <zip>91710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St Petersburg</city>
        <state>Florida</state>
        <zip>33716</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30338</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Avon</city>
        <state>Indiana</state>
        <zip>46123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Morrisville</city>
        <state>Pennsylvania</state>
        <zip>19067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Buenos Aires</city>
        <zip>1056</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Caba</city>
        <zip>C1428DCO</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rosario</city>
        <zip>S2000CXP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Floridablanca</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Medellin-Antioquia</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guatemala</city>
        <zip>01010</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guatemala</city>
        <zip>01014</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aguascaliente</city>
        <zip>20230</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Celaya</city>
        <zip>38000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guadalajara</city>
        <zip>44600</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guadalajara</city>
        <zip>44650</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Queretaro</city>
        <zip>76000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Colombia</country>
    <country>Guatemala</country>
    <country>Mexico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 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>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/NCT01691989
org study id: WC28325
nct id: NCT01691989
lead sponsor: 
This multicenter, randomized, double-blind, placebo-controlled study will assess the
      efficacy, safety and tolerability of aleglitazar compared with placebo when added to a
      sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with
      type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or
      sulfonylurea plus metformin therapy. Patients will be randomized to receive oral doses of 150
      mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline in hemoglobin HbA1c
time frame: From baseline to week 26
measure: Change in lipid profile
time frame: From baseline to week 26
measure: Change from baseline in fasting plasma glucose
time frame: From baseline to week 26
measure: Responder rate as defined of hemoglobin HbAc1 <7.0% (<6.5%)
time frame: From baseline to week 26
measure: Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)
time frame: From baseline to week 26
measure: Change from baseline in markers of insulin sensitivity and cardiovascular risk
time frame: From baseline to week 26
measure: Safety: incidence of adverse events
time frame: 30 weeks (26 weeks treatment and 4 weeks follow-up)
arm group label: aleglitazar
arm group type: Experimental
arm group label: placebo
arm group type: Experimental
intervention type: Drug
intervention name: aleglitazar
description: 150 mcg orally once a day for 26 weeks
arm group label: aleglitazar
intervention type: Drug
intervention name: placebo
description: oral doses once a day for 26 weeks
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Argentina
country: Colombia
country: Guatemala
country: Mexico
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2