<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/NCT01691846</url>
  </required_header>
  <id_info>
    <org_study_id>BC28035</org_study_id>
    <nct_id>NCT01691846</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 Metformin Alone</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Plus Metformin Combination Therapy Compared With Placebo Plus Metformin in Patients With T2D Inadequately Controlled With 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>
      This multicenter, randomized, double-blind, placebo-controlled study will assess the&#xD;
      efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared&#xD;
      with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately&#xD;
      controlled with metformin monotherapy. Patients will be randomized to receive oral doses of&#xD;
      150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26&#xD;
      weeks.&#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 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 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">200</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+metformin</intervention_name>
    <description>150 mcg aleglitazar given orally once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)</description>
    <arm_group_label>aleglitazar</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo+metformin</intervention_name>
    <description>Oral doses of matching placebo once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)</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 metformin monotherapy for at least 12 weeks prior to&#xD;
             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;
          -  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>Hawaiian Gardens</city>
        <state>California</state>
        <zip>90716</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>West Hills</city>
        <state>California</state>
        <zip>91307</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>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08753</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>Beaver</city>
        <state>Pennsylvania</state>
        <zip>15009</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>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>Knoxville</city>
        <state>Tennessee</state>
        <zip>37919</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>Spokane</city>
        <state>Washington</state>
        <zip>99202</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>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>Guadalajara</city>
        <zip>44650</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>Pachuca</city>
        <zip>42060</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>Argentina</country>
    <country>Mexico</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Peru</country>
  </removed_countries>
  <verification_date>February 2017</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>February 22, 2017</last_update_submitted>
  <last_update_submitted_qc>February 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
  </intervention_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/NCT01691846
org study id: BC28035
nct id: NCT01691846
lead sponsor: 
This multicenter, randomized, double-blind, placebo-controlled study will assess the
      efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared
      with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately
      controlled with metformin monotherapy. 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 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: aleglitazar
arm group type: Experimental
arm group label: placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: aleglitazar+metformin
description: 150 mcg aleglitazar given orally once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)
arm group label: aleglitazar
intervention type: Drug
intervention name: placebo+metformin
description: Oral doses of matching placebo once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)
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: Mexico
country: United States
country: Peru
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin