<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/NCT01691755</url>
  </required_header>
  <id_info>
    <org_study_id>BC28034</org_study_id>
    <nct_id>NCT01691755</nct_id>
  </id_info>
  <brief_title>A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Monotherapy Compared With Placebo in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Drug-Naïve to Anti-Hyperglycemic 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 monotherapy compared with placebo in&#xD;
      patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic&#xD;
      therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily&#xD;
      or placebo. The anticipated time on study treatment is 26 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 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>
    <allocation>Randomized</allocation>
    <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 A1c (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 homeostatic index of beta cell function (HOMA-BCF)</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">196</enrollment>
  <condition>Diabetes Mellitus Type 2</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>aleglitazar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <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>
  <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>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/=18 years of age&#xD;
&#xD;
          -  Diagnosis of diabetes mellitus, type 2 within 12 months prior to screening&#xD;
&#xD;
          -  Patients who have not received a anti-hyperglycemic medication for at least 12 weeks&#xD;
             prior to screening and for not longer than 3 consecutive months in the past&#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 peroxisome proliferator&#xD;
             activated receptor (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;
          -  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>Santa Ana</city>
        <state>California</state>
        <zip>92701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Hills</city>
        <state>California</state>
        <zip>91307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cooper City</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</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>Atlanta</city>
        <state>Georgia</state>
        <zip>30338</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</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>St Peters</city>
        <state>Missouri</state>
        <zip>63376</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Altoona</city>
        <state>Pennsylvania</state>
        <zip>16602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Scranton</city>
        <state>Pennsylvania</state>
        <zip>18510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tipton</city>
        <state>Pennsylvania</state>
        <zip>16684</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>Knoxville</city>
        <state>Tennessee</state>
        <zip>37919</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aguascaliente</city>
        <zip>20230</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cuernavaca</city>
        <zip>62250</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Culiacan</city>
        <zip>80020</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durango</city>
        <zip>34000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durango</city>
        <zip>34080</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>Mexico City</city>
        <zip>11650</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Monterrey</city>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pachuca</city>
        <zip>42090</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Queretaro</city>
        <zip>76000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampico</city>
        <zip>89000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>El Salvador</country>
    <country>Guatemala</country>
  </removed_countries>
  <verification_date>August 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>
  <disposition_first_submitted>August 9, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>August 9, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">August 11, 2016</disposition_first_posted>
  <last_update_submitted>August 9, 2016</last_update_submitted>
  <last_update_submitted_qc>August 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 11, 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, but a results disposition has been submitted           -->
</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/NCT01691755
org study id: BC28034
nct id: NCT01691755
lead sponsor: 
This multicenter, randomized, double-blind, placebo-controlled study will assess the
      efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in
      patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic
      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.
allocation: Randomized
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 A1c (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 homeostatic index of beta cell function (HOMA-BCF)
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: Placebo
arm group type: Placebo Comparator
arm group label: aleglitazar
arm group type: Experimental
intervention type: Drug
intervention name: Placebo
description: oral doses once a day for 26 weeks
arm group label: Placebo
intervention type: Drug
intervention name: aleglitazar
description: 150 mcg orally once a day for 26 weeks
arm group label: aleglitazar
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: Mexico
country: United States
country: El Salvador
country: Guatemala
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2