<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/NCT01689142</url>
  </required_header>
  <id_info>
    <org_study_id>EFC12512</org_study_id>
    <secondary_id>U1111-1130-3649</secondary_id>
    <nct_id>NCT01689142</nct_id>
  </id_info>
  <brief_title>Comparison of a New Formulation of Insulin Glargine With Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus</brief_title>
  <acronym>EDITION JP II</acronym>
  <official_title>A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus With a 6 Month Safety Extension Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of&#xD;
      change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese&#xD;
      patients with type 2 diabetes mellitus.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To compare a new formulation of insulin glargine and Lantus in terms of change in fasting&#xD;
      plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose&#xD;
      (SMPG) profile.&#xD;
&#xD;
      To compare a new formulation of insulin glargine and Lantus in terms of occurrence of&#xD;
      hypoglycemia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The duration of study will consist of:&#xD;
&#xD;
        -  Up to 2-week screening period;&#xD;
&#xD;
        -  6-month open-label comparative efficacy and safety treatment period;&#xD;
&#xD;
        -  6-month open-label comparative safety extension period;&#xD;
&#xD;
        -  4-week post-treatment safety follow-up period&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">November 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in HbA1c</measure>
    <time_frame>baseline, 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of HbA1c responders (HbA1c &lt; 7%; &lt; 6.5%)</measure>
    <time_frame>up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in FPG</measure>
    <time_frame>baseline, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in pre-basal insulin injection SMPG</measure>
    <time_frame>baseline, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 8-point SMPG profiles</measure>
    <time_frame>baseline, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)</measure>
    <time_frame>baseline, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in variability of plasma glucose profile</measure>
    <time_frame>baseline, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in daily basal insulin dose</measure>
    <time_frame>baseline, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with various types of hypoglycemia events</measure>
    <time_frame>up to 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>New formulation of insulin glargine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>once daily in the evening on-top of oral antihyperglycemic drug (OADs)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lantus (insulin glargine)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>once daily in the evening on-top of OADs</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin glargine new formulation (HOE901)</intervention_name>
    <description>Pharmaceutical form: solution Route of administration: subcutaneous</description>
    <arm_group_label>New formulation of insulin glargine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin glargine (HOE901)</intervention_name>
    <description>Pharmaceutical form: solution Route of administration: subcutaneous</description>
    <arm_group_label>Lantus (insulin glargine)</arm_group_label>
    <other_name>Lantus</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
        o Patients with type 2 diabetes mellitus diagnosed for at least 1 year at the time of&#xD;
        screening visit treated with basal insulin in combination with oral antihyperglycemic drugs&#xD;
        (OADs) for at least 6 months before screening visit;&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Age &lt; 18 years at screening visit;&#xD;
&#xD;
          -  BMI(body mass index) ≥ 35 kg/m2 at screening visit;&#xD;
&#xD;
          -  HbA1c &lt; 7.0% or &gt; 10% (national glycohemoglobin standardization program [NGSP] value)&#xD;
             at screening visit;&#xD;
&#xD;
          -  Diabetes other than type 2 diabetes mellitus;&#xD;
&#xD;
          -  Patients on self-monitoring of blood glucose less than 6 months before screening&#xD;
             visit;&#xD;
&#xD;
          -  Patients using pre-mix insulins, insulin detemir at 2 times or more a day, or GLP 1&#xD;
             receptor agonists in the last 3 months before screening visit;&#xD;
&#xD;
          -  Patients using mealtime insulin (rapid-acting insulin analogue and short-acting&#xD;
             insulin) for more than 10 days in the last 3 months before screening visit;&#xD;
&#xD;
          -  Use of insulin pump in the last 6 months before screening visit;&#xD;
&#xD;
          -  Initiation of new glucose-lowering medications and/or weight loss drugs in the last 3&#xD;
             months before screening visit;&#xD;
&#xD;
          -  Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic&#xD;
             ketoacidosis in the last 6 months before screening visit;&#xD;
&#xD;
          -  Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic&#xD;
             retinopathy or macular edema likely to require treatment (eg, laser, surgical&#xD;
             treatment or injectable drugs) during the study period.&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#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 Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 392226</name>
      <address>
        <city>Amagasaki-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392218</name>
      <address>
        <city>Chigasaki-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392212</name>
      <address>
        <city>Chiyoda-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392209</name>
      <address>
        <city>Chuo-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392210</name>
      <address>
        <city>Chuo-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392208</name>
      <address>
        <city>Chuoh-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392217</name>
      <address>
        <city>Ebina-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392216</name>
      <address>
        <city>Fujisawa-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392222</name>
      <address>
        <city>Higashiosaka-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392223</name>
      <address>
        <city>Izumisano-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392215</name>
      <address>
        <city>Kamakura-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392225</name>
      <address>
        <city>Kashiwara-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392205</name>
      <address>
        <city>Kawagoe-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392204</name>
      <address>
        <city>Kawaguchi-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392206</name>
      <address>
        <city>Kisarazu-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392201</name>
      <address>
        <city>Koriyama-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392228</name>
      <address>
        <city>Kurashiki-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392229</name>
      <address>
        <city>Matsuyama-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392230</name>
      <address>
        <city>Matsuyama-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392211</name>
      <address>
        <city>Mitaka-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392220</name>
      <address>
        <city>Nagoya-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392227</name>
      <address>
        <city>Nishinomiya-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392203</name>
      <address>
        <city>Ogawa-Machi, Hikigun</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392231</name>
      <address>
        <city>Okawa-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392224</name>
      <address>
        <city>Osaka-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392207</name>
      <address>
        <city>Shinjuku-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392219</name>
      <address>
        <city>Shizuoka-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392221</name>
      <address>
        <city>Takatsuki-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392202</name>
      <address>
        <city>Ushiku-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392213</name>
      <address>
        <city>Yokohama-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392214</name>
      <address>
        <city>Yokohama-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>June 4, 2014</last_update_submitted>
  <last_update_submitted_qc>June 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 5, 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>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Glargine</mesh_term>
  </intervention_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/NCT01689142
org study id: EFC12512
secondary id: U1111-1130-3649
nct id: NCT01689142
lead sponsor: 
has dmc: No
Primary Objective:

      To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of
      change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese
      patients with type 2 diabetes mellitus.

      Secondary Objectives:

      To compare a new formulation of insulin glargine and Lantus in terms of change in fasting
      plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose
      (SMPG) profile.

      To compare a new formulation of insulin glargine and Lantus in terms of occurrence of
      hypoglycemia
The duration of study will consist of:

        -  Up to 2-week screening period;

        -  6-month open-label comparative efficacy and safety treatment period;

        -  6-month open-label comparative safety extension period;

        -  4-week post-treatment safety follow-up period
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in HbA1c
time frame: baseline, 6 months
measure: Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)
time frame: up to 6 months
measure: Change from baseline in FPG
time frame: baseline, 6 months
measure: Change from baseline in pre-basal insulin injection SMPG
time frame: baseline, 6 months
measure: Change from baseline in 8-point SMPG profiles
time frame: baseline, 6 months
measure: Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)
time frame: baseline, 6 months
measure: Change from baseline in variability of plasma glucose profile
time frame: baseline, 6 months
measure: Change from baseline in daily basal insulin dose
time frame: baseline, 6 months
measure: Number of patients with various types of hypoglycemia events
time frame: up to 6 months
arm group label: New formulation of insulin glargine
arm group type: Experimental
description: once daily in the evening on-top of oral antihyperglycemic drug (OADs)
arm group label: Lantus (insulin glargine)
arm group type: Active Comparator
description: once daily in the evening on-top of OADs
intervention type: Drug
intervention name: Insulin glargine new formulation (HOE901)
description: Pharmaceutical form: solution Route of administration: subcutaneous
arm group label: New formulation of insulin glargine
intervention type: Drug
intervention name: Insulin glargine (HOE901)
description: Pharmaceutical form: solution Route of administration: subcutaneous
arm group label: Lantus (insulin glargine)
other name: Lantus
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
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country: Japan
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Glargine