<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/NCT01676233</url>
  </required_header>
  <id_info>
    <org_study_id>PDY12335</org_study_id>
    <secondary_id>U1111-1129-3633</secondary_id>
    <nct_id>NCT01676233</nct_id>
  </id_info>
  <brief_title>Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus</brief_title>
  <official_title>A Randomized, Open-label, 2-treatment Crossover Study of a New Formulation of Insulin Glargine Comparing to Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus on Treatment With Basal-bolus Insulin</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 24-hour glycemic profile in continuous glucose monitoring (CGM) between a&#xD;
      new formulation of insulin glargine and Lantus at steady state&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose&#xD;
           (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;&#xD;
&#xD;
        -  To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters&#xD;
           (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));&#xD;
&#xD;
        -  To compare the occurrence of hypoglycemia between the 2 treatments;&#xD;
&#xD;
        -  To assess the safety and tolerability of a new formulation of insulin glargine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      66 days&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 24-hour blood glucose profile measured by continuous glucose monitoring</measure>
    <time_frame>Baseline, Day 28, Day 56</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia categorized by the definition of American Diabetes Association</measure>
    <time_frame>Up to Day 56</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting plasma glucose from baseline to each treatment end by treatment</measure>
    <time_frame>Baseline, Day 28, Day 56</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment</measure>
    <time_frame>Baseline, Day 28, Day 56</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c from baseline to each treatment end by treatment</measure>
    <time_frame>Baseline, Day 28, Day 56</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal</description>
  </arm_group>
  <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>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
  </intervention>
  <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>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Japanese patients with Type 1 Diabetes Mellitus (T1DM) on treatment with basal-bolus&#xD;
             insulin;&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Age &lt; 20 years at written informed consent;&#xD;
&#xD;
          -  HbA1c &lt; 6.5% or &gt; 10.0% at screening&#xD;
&#xD;
          -  Diabetes mellitus (DM) other than T1DM;&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt; 35.0 kg/m2 at screening visit&#xD;
&#xD;
          -  Any contraindication to use of insulin glargine as defined in the Japanese Package&#xD;
             Insert&#xD;
&#xD;
          -  Hypoglycemia unawareness or history of metabolic acidosis, including hospitalization&#xD;
             for diabetic ketoacidosis during the 24 weeks prior to screening visit&#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>20 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 392001</name>
      <address>
        <city>Kumamoto-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>August 16, 2013</last_update_submitted>
  <last_update_submitted_qc>August 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2013</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 1</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/NCT01676233
org study id: PDY12335
secondary id: U1111-1129-3633
nct id: NCT01676233
lead sponsor: 
has dmc: No
Primary Objective:

      - To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a
      new formulation of insulin glargine and Lantus at steady state

      Secondary Objectives:

        -  To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose
           (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;

        -  To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters
           (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));

        -  To compare the occurrence of hypoglycemia between the 2 treatments;

        -  To assess the safety and tolerability of a new formulation of insulin glargine.
66 days
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in 24-hour blood glucose profile measured by continuous glucose monitoring
time frame: Baseline, Day 28, Day 56
measure: Hypoglycemia categorized by the definition of American Diabetes Association
time frame: Up to Day 56
measure: Change in fasting plasma glucose from baseline to each treatment end by treatment
time frame: Baseline, Day 28, Day 56
measure: Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment
time frame: Baseline, Day 28, Day 56
measure: Change in HbA1c from baseline to each treatment end by treatment
time frame: Baseline, Day 28, Day 56
arm group label: Sequence 1
arm group type: Experimental
description: Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal
arm group label: Sequence 2
arm group type: Experimental
description: Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal
intervention type: Drug
intervention name: insulin glargine (HOE901)
description: Pharmaceutical form: solution Route of administration: subcutaneous
arm group label: Sequence 1
arm group label: Sequence 2
intervention type: Drug
intervention name: insulin glargine- new formulation (HOE901)
description: Pharmaceutical form: solution Route of administration: subcutaneous
arm group label: Sequence 1
arm group label: Sequence 2
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Glargine