<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/NCT03042325</url>
  </required_header>
  <id_info>
    <org_study_id>SYR-322-4001</org_study_id>
    <secondary_id>U1111-1174-1852</secondary_id>
    <nct_id>NCT03042325</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Alogliptin in Indian Participants With Type 2 Diabetes Mellitus</brief_title>
  <official_title>Prospective, Multi-center, Open-label, Phase IV Study to Evaluate the Safety and Efficacy of Alogliptin as Monotherapy or Add on Therapy in Indian Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of alogliptin tablets when&#xD;
      given as monotherapy or add on therapy in participants who are on standard care for&#xD;
      management of Type 2 Diabetes Mellitus (T2DM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called alogliptin. Alogliptin is being tested to treat&#xD;
      people who have Type 2 Diabetes Mellitus (T2DM). This study will look at side effects and&#xD;
      glycemic control in people who take alogliptin in addition to standard care.&#xD;
&#xD;
      The study will enroll approximately 300 patients. All participants will receive alogliptin&#xD;
      tablets at a dose determined based on the creatinine clearance.&#xD;
&#xD;
      The recommended dose of alogliptin is 25 mg once daily with normal or mildly impaired renal&#xD;
      function (creatinine clearance [CrCl] ≥60 mL/min), dose of 12.5 mg for participants with&#xD;
      moderate renal impairment (CrCl ≥30 to &lt;60 mL/min), and 6.25 mg for participants severe renal&#xD;
      impairment (CrCl ≥15 to &lt;30 mL/min). Participants with end-stage renal disease (ESRD) (CrCl&#xD;
      &lt;15 mL/min or requiring hemodialysis) will be excluded, in addition to standard care for the&#xD;
      management of T2DM.&#xD;
&#xD;
      All participants will be asked to take one tablet every morning each day throughout the&#xD;
      study.&#xD;
&#xD;
      This multi-center trial will be conducted in India. The overall time to participate in this&#xD;
      study is up to 33 weeks. Participants will make multiple visits to the clinic, and will be&#xD;
      contacted by telephone 30 days after last dose of study drug for a follow-up assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Business decision, no safety or efficacy concerns&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 30, 2017</start_date>
  <completion_date type="Anticipated">January 15, 2018</completion_date>
  <primary_completion_date type="Anticipated">January 15, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to 30 days after the last dose of study drug (up to 30 weeks)</time_frame>
    <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants with Adverse Drug Reactions (ADRs) and Unexpected ADRs</measure>
    <time_frame>Baseline up to 30 days after the last dose of study drug (up to 30 weeks)</time_frame>
    <description>An ADR is any response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of diseases or for the restoration, correction or modification of physiological function. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Glycosylated Haemoglobin (HbA1c) at Weeks 13 and 26</measure>
    <time_frame>Baseline and Weeks 13 and 26</time_frame>
    <description>The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at weeks 13 and 26 relative to Baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants with Glycosylated Hemoglobin &lt; 7.0%</measure>
    <time_frame>Weeks 13 and 26</time_frame>
    <description>Clinical response at Weeks 13 and 26 will be assessed by the percentage of participants with HbA1c less than 7%.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Alogliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alogliptin 25 mg, tablets, orally, once, daily for 26 weeks in addition to standard care for the management of Type 2 Diabetes Mellitus (T2DM). Dose will be adjusted as per creatinine clearance [CrCl].</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alogliptin</intervention_name>
    <description>Alogliptin tablets</description>
    <arm_group_label>Alogliptin</arm_group_label>
    <other_name>SYR-322</other_name>
    <other_name>Nesina</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Participants with T2DM who are dipeptidyl peptidase-4 (DPP-4) inhibitor-naive; including&#xD;
        alogliptin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has contraindication or limitation for administration of alogliptin tablets according&#xD;
             to the approved label/Prescribing Information.&#xD;
&#xD;
          2. Participants treated with alogliptin tablets outside the approved label/ prescribing&#xD;
             information.&#xD;
&#xD;
          3. Has end-stage renal disease (ESRD) (Creatinine Clearance (CrCl) &lt;15 mL/min or&#xD;
             requiring hemodialysis).&#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>Medical Director Clinical Science</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>October 18, 2017</last_update_submitted>
  <last_update_submitted_qc>October 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug therapy</keyword>
  <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>Alogliptin</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/NCT03042325
org study id: SYR-322-4001
secondary id: U1111-1174-1852
nct id: NCT03042325
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety and efficacy of alogliptin tablets when
      given as monotherapy or add on therapy in participants who are on standard care for
      management of Type 2 Diabetes Mellitus (T2DM).
The drug being tested in this study is called alogliptin. Alogliptin is being tested to treat
      people who have Type 2 Diabetes Mellitus (T2DM). This study will look at side effects and
      glycemic control in people who take alogliptin in addition to standard care.

      The study will enroll approximately 300 patients. All participants will receive alogliptin
      tablets at a dose determined based on the creatinine clearance.

      The recommended dose of alogliptin is 25 mg once daily with normal or mildly impaired renal
      function (creatinine clearance [CrCl] ≥60 mL/min), dose of 12.5 mg for participants with
      moderate renal impairment (CrCl ≥30 to <60 mL/min), and 6.25 mg for participants severe renal
      impairment (CrCl ≥15 to <30 mL/min). Participants with end-stage renal disease (ESRD) (CrCl
      <15 mL/min or requiring hemodialysis) will be excluded, in addition to standard care for the
      management of T2DM.

      All participants will be asked to take one tablet every morning each day throughout the
      study.

      This multi-center trial will be conducted in India. The overall time to participate in this
      study is up to 33 weeks. Participants will make multiple visits to the clinic, and will be
      contacted by telephone 30 days after last dose of study drug for a follow-up assessment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to 30 days after the last dose of study drug (up to 30 weeks)
description: An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
measure: Percentage of Participants with Adverse Drug Reactions (ADRs) and Unexpected ADRs
time frame: Baseline up to 30 days after the last dose of study drug (up to 30 weeks)
description: An ADR is any response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of diseases or for the restoration, correction or modification of physiological function. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility.
measure: Change from Baseline in Glycosylated Haemoglobin (HbA1c) at Weeks 13 and 26
time frame: Baseline and Weeks 13 and 26
description: The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at weeks 13 and 26 relative to Baseline.
measure: Percentage of Participants with Glycosylated Hemoglobin < 7.0%
time frame: Weeks 13 and 26
description: Clinical response at Weeks 13 and 26 will be assessed by the percentage of participants with HbA1c less than 7%.
arm group label: Alogliptin
arm group type: Experimental
description: Alogliptin 25 mg, tablets, orally, once, daily for 26 weeks in addition to standard care for the management of Type 2 Diabetes Mellitus (T2DM). Dose will be adjusted as per creatinine clearance [CrCl].
intervention type: Drug
intervention name: Alogliptin
description: Alogliptin tablets
arm group label: Alogliptin
other name: SYR-322
other name: Nesina
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director Clinical Science
role: Study Director
affiliation: Takeda
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Alogliptin