<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/NCT02231021</url>
  </required_header>
  <id_info>
    <org_study_id>ALO-IIT-012</org_study_id>
    <nct_id>NCT02231021</nct_id>
  </id_info>
  <brief_title>The Practical Evidence of Antidiabetic Combination Therapy in Korea</brief_title>
  <acronym>PEAK</acronym>
  <official_title>Multicenter, Randomized, Double Blind, Three-arm Parallel Group Study to Evaluate Efficacy and Safety of Alogliptin and Pioglitazone Combination Therapy on Glucose Control in Type 2 Diabetes Subjects Who Have Inadequate Control With Metformin Monotherapy in Korea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kun-Ho Yoon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Catholic University of Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluate the efficacy and safety of alogliptin and pioglitazone combination&#xD;
      therapy in comparison with either alogliptin or pioglitazone on glucose control in the&#xD;
      metformin-treated type 2 diabetic patients in Korea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pathophysiology of type 2 diabetes is known as insulin resistance and progressive beta cell&#xD;
      dysfunction.&#xD;
&#xD;
      Combination therapy with biguanides, glucagon-like peptide-1(GLP-1) agonists or dipeptidyl&#xD;
      peptidase-4 inhibitor(DPP4I) and thiazolidinediones(TZD) seems reasonable theoretically, for&#xD;
      their effects on different pathophysiologic defects.&#xD;
&#xD;
      Current treatment guidelines recommend a stepwise approach starting with lifestyle&#xD;
      modification or lifestyle modification + metformin monotherapy, with recent focusing on&#xD;
      patient individualization.&#xD;
&#xD;
      In Korea, Korean Diabetes Association also recommends stepwise approach and at the same time,&#xD;
      emphasizes on the initial aggressive treatment including oral combination or insulin therapy&#xD;
      according to HbA1c level to achieve target goal &lt;6.5%.&#xD;
&#xD;
      Guide to the efficacy, timing, options of combination therapy is not clearly defined due to&#xD;
      lack of sufficient evidences yet.&#xD;
&#xD;
      There is no clear report to demonstrate the clinical benefit of initial TZD and DPP4I&#xD;
      combination therapy in the Korean.&#xD;
&#xD;
      Thus it is reasonable to study the effect of combination therapy in the patients with&#xD;
      sub-optimal glucose control with metformin therapy only, comparing various combination&#xD;
      options metformin with DPP4I only, TZD only, or both.&#xD;
&#xD;
      The hypothesis of this study is that combination therapy of alogliptin and pioglitazone added&#xD;
      on the metformin has superior effect on HbA1c reduction than metformin and either alogliptin&#xD;
      or pioglitazone in 6 month treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">January 28, 2019</completion_date>
  <primary_completion_date type="Actual">October 22, 2018</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in glycohemoglobin(HbA1c) from baseline</measure>
    <time_frame>baseline, 24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects achieving HbA1c &lt; 7.0%</measure>
    <time_frame>24 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects achieving HbA1c &lt;6.5%</measure>
    <time_frame>24 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in glycated albumin(GA) from baseline</measure>
    <time_frame>baseline, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in GA/HbA1c ratio from baseline</measure>
    <time_frame>baseline, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood sugar from baseline</measure>
    <time_frame>baseline, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of hyperglycemic rescue</measure>
    <time_frame>12 week</time_frame>
    <description>at Week 12, HbA1c &gt;9.0%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c from baseline</measure>
    <time_frame>12 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total cholesterol from baseline</measure>
    <time_frame>baseline, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in triglycerides from baseline</measure>
    <time_frame>baseline, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LDL-cholesterol from baseline</measure>
    <time_frame>baseline, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HDL-cholesterol from baseline</measure>
    <time_frame>baseline, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in glycated albumin(GA) from baseline</measure>
    <time_frame>baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in GA/HbA1c ratio from baseline</measure>
    <time_frame>baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood sugar from baseline</measure>
    <time_frame>baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total cholesterol from baseline</measure>
    <time_frame>baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in triglycerides from baseline</measure>
    <time_frame>baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LDL-cholesterol from baseline</measure>
    <time_frame>baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HDL-cholesterol from baseline</measure>
    <time_frame>baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Homeostasis Model Assessment-Insulin resistance(HOMA-IR) from baseline</measure>
    <time_frame>baseline, 24 weeks</time_frame>
    <description>a marker of insulin resistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Homeostasis Model Assessment - beta cell (HOMA-beta) from baseline</measure>
    <time_frame>baseline, 24 weeks</time_frame>
    <description>a marker of beta cell function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in highly sensitive C reactive protein(hs-CRP) from baseline</measure>
    <time_frame>baseline, 24 weeks</time_frame>
    <description>a marker of inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Plasmonogen activator inhibitor-1(PAI-1) from baseline</measure>
    <time_frame>baseline, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in B-type natriuretic pepetide(BNP) from baseline</measure>
    <time_frame>baseline, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>event rate of hypoglycemia</measure>
    <time_frame>upto 24 weeks</time_frame>
    <description>A number of total event of hypoglycemia defined as blood glucose &lt;70mg/dL or subjective symptom of typical hypoglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>No of subject with adverse event of special interest</measure>
    <time_frame>upto 24 weeks</time_frame>
    <description>The event of special interest include&#xD;
heart failure&#xD;
cardiovascular effect other than heart failure&#xD;
edema&#xD;
weight gain&#xD;
urinary bladder tumor&#xD;
macular edema&#xD;
fracture of bone&#xD;
pancreatitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of serious adverse events</measure>
    <time_frame>upto 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subject with hypersensitivity to study drugs</measure>
    <time_frame>upto 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subject with any abnormality of laboratory evaluation</measure>
    <time_frame>12 week</time_frame>
    <description>Complete Blood count&#xD;
BUN, Creatinine, AST, ALT, Calcium, Phosphorous, Sodium, Potassium, Total Protein, Albumin, Total Bilirubin, Gamma-glutamyl transferase, Alkaline phosphatase, Creatinine Kinase, amylase, lipase&#xD;
Urine analysis including microscopic examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subject with any abnormality of laboratory evaluation</measure>
    <time_frame>24 week</time_frame>
    <description>Complete Blood count&#xD;
Blood urea nigrogen, Creatinine, Aspartate aminotransferase, Alanine Aminotransferase, Calcium, Phosphorous, Sodium, Potassium, Total Protein, Albumin, Total Bilirubin, Gamma-glutamyl transferase, Alkaline phosphatase, Creatinine Kinase, amylase, lipase&#xD;
Urine analysis including microscopic examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subject with any change of findings in Chest X-ray from baseline</measure>
    <time_frame>24 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subject with any change of findings in electrocardiogram from baseline</measure>
    <time_frame>24 week</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">216</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>alogliptin + pioglitazone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>alogliptin 25 mg 1 tablet daily for 24 weeks pioglitazone 30 mg 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll</description>
  </arm_group>
  <arm_group>
    <arm_group_label>alogliptin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>alogliptin 25 mg 1 tablet daily for 24 weeks pioglitazone matching placebo 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pioglitazone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>alogliptin matching placebo 1 tablet daily for 24 weeks pioglitazone 30 mg 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>alogliptin</intervention_name>
    <description>alogliptin 25 mg add-on background medication metformin</description>
    <arm_group_label>alogliptin</arm_group_label>
    <other_name>Nesina</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pioglitazone</intervention_name>
    <description>pioglitazone 30 mg add-on background medication metformin</description>
    <arm_group_label>Pioglitazone</arm_group_label>
    <other_name>actos</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>alogliptin + pioglitazone</intervention_name>
    <description>alogliptin 25 mg and pioglitazone 30 mg add-on background medication metformin</description>
    <arm_group_label>alogliptin + pioglitazone</arm_group_label>
    <other_name>Nesina</other_name>
    <other_name>Actos</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In the opinion of the investigator, the subject is capable of understanding and&#xD;
             complying with protocol requirements&#xD;
&#xD;
          -  The subject or, when applicable, the subject's legally acceptable representative signs&#xD;
             and dates a written, informed consent form and any required privacy authorization&#xD;
             prior to the initiation of any study procedures&#xD;
&#xD;
          -  The subjects diagnosed type 2 diabetes mellitus at least 6 months&#xD;
&#xD;
          -  Male and female and 19 to 75 years, inclusive&#xD;
&#xD;
          -  7.0% =&lt;HbA1c =&lt;10.0%&#xD;
&#xD;
          -  18.5 Kg/m2 =&lt;Body Mass Index(BMI) =&lt;45 kg/m2&#xD;
&#xD;
          -  systolic/diastolic blood pressure =&lt;160/100 at baseline&#xD;
&#xD;
          -  hemoglobin of at least 12 g/dL for men and at least 10 g/dL for women&#xD;
&#xD;
          -  A female subject of childbearing potential who is sexually active with a nonsterilized&#xD;
             male partner agrees to routinely use adequate contraception from singing of informed&#xD;
             consent throughout the duration of the study&#xD;
&#xD;
          -  Patient who receiving maximal tolerated dose of metformin at least 12 weeks without&#xD;
             dose change (for metformin, &gt;= 1,000 mg/day&#xD;
&#xD;
          -  fasting c-peptide greater than 0.78 ng/mL(0.26 nmol/L) at baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient has received investigational compound(alogliptin or pioglitazone) within&#xD;
             180 days prior to baseline&#xD;
&#xD;
          -  Patient who currently taking or need to take andy medicine which may exert a&#xD;
             significant influence on blood glucose control except metformin.&#xD;
&#xD;
          -  Severe renal disease : estimated glomerular filtration rate &lt;50 mL/min&#xD;
&#xD;
          -  Severe liver disease or AST, ALT &gt;= 2.5 upper limit of normal&#xD;
&#xD;
          -  Cardiac status : New York Heart Association III ~ IV&#xD;
&#xD;
          -  Hypopituitarism or adrenal insufficiency&#xD;
&#xD;
          -  Patient who has a history of major surgery, Severe infections, Severe traumas within 6&#xD;
             months&#xD;
&#xD;
          -  Patients who has diagnosed malignancy within 5yrs ,&#xD;
&#xD;
          -  Patients with active bladder cancer&#xD;
&#xD;
          -  Patient with rare hereditary problems of galactose intolerance, the Lapp lactase&#xD;
             deficiency or glucose-galactose malabsorption&#xD;
&#xD;
          -  Patient who has a history of hypersensitivity to Alogliptin, Pioglitazone or their&#xD;
             ingredients&#xD;
&#xD;
          -  Pregnant or lactating woman&#xD;
&#xD;
          -  Patient who has history of excessive alcohol abuse&#xD;
&#xD;
          -  Subject who is involved in other clinical trial within 90 days prior to initiation of&#xD;
             this study.&#xD;
&#xD;
          -  Subject who the investigator deems inappropriate to participate in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kun-Ho Yoon, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul St Mary's Hospital, The Catholic Univerisity of Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul St Mary's Hospital, The Catholic University of Korea</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Kun-Ho Yoon</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus, Type 2</keyword>
  <keyword>alogliptin</keyword>
  <keyword>pioglitazone</keyword>
  <keyword>DPP4 inhibitor</keyword>
  <keyword>thiazolidinedione</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>Pioglitazone</mesh_term>
    <mesh_term>Alogliptin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02231021
org study id: ALO-IIT-012
nct id: NCT02231021
lead sponsor: 
collaborator: 
has dmc: No
This study evaluate the efficacy and safety of alogliptin and pioglitazone combination
      therapy in comparison with either alogliptin or pioglitazone on glucose control in the
      metformin-treated type 2 diabetic patients in Korea.
Pathophysiology of type 2 diabetes is known as insulin resistance and progressive beta cell
      dysfunction.

      Combination therapy with biguanides, glucagon-like peptide-1(GLP-1) agonists or dipeptidyl
      peptidase-4 inhibitor(DPP4I) and thiazolidinediones(TZD) seems reasonable theoretically, for
      their effects on different pathophysiologic defects.

      Current treatment guidelines recommend a stepwise approach starting with lifestyle
      modification or lifestyle modification + metformin monotherapy, with recent focusing on
      patient individualization.

      In Korea, Korean Diabetes Association also recommends stepwise approach and at the same time,
      emphasizes on the initial aggressive treatment including oral combination or insulin therapy
      according to HbA1c level to achieve target goal <6.5%.

      Guide to the efficacy, timing, options of combination therapy is not clearly defined due to
      lack of sufficient evidences yet.

      There is no clear report to demonstrate the clinical benefit of initial TZD and DPP4I
      combination therapy in the Korean.

      Thus it is reasonable to study the effect of combination therapy in the patients with
      sub-optimal glucose control with metformin therapy only, comparing various combination
      options metformin with DPP4I only, TZD only, or both.

      The hypothesis of this study is that combination therapy of alogliptin and pioglitazone added
      on the metformin has superior effect on HbA1c reduction than metformin and either alogliptin
      or pioglitazone in 6 month treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in glycohemoglobin(HbA1c) from baseline
time frame: baseline, 24 weeks
measure: Proportion of subjects achieving HbA1c < 7.0%
time frame: 24 week
measure: Proportion of subjects achieving HbA1c <6.5%
time frame: 24 week
measure: Changes in glycated albumin(GA) from baseline
time frame: baseline, 24 weeks
measure: Change in GA/HbA1c ratio from baseline
time frame: baseline, 24 weeks
measure: Change in fasting blood sugar from baseline
time frame: baseline, 24 weeks
measure: Incidence of hyperglycemic rescue
time frame: 12 week
description: at Week 12, HbA1c >9.0%
measure: Change in HbA1c from baseline
time frame: 12 week
measure: Change in total cholesterol from baseline
time frame: baseline, 24 weeks
measure: Change in triglycerides from baseline
time frame: baseline, 24 weeks
measure: Change in LDL-cholesterol from baseline
time frame: baseline, 24 weeks
measure: Change in HDL-cholesterol from baseline
time frame: baseline, 24 weeks
measure: Changes in glycated albumin(GA) from baseline
time frame: baseline, 12 weeks
measure: Change in GA/HbA1c ratio from baseline
time frame: baseline, 12 weeks
measure: Change in fasting blood sugar from baseline
time frame: baseline, 12 weeks
measure: Change in total cholesterol from baseline
time frame: baseline, 12 weeks
measure: Change in triglycerides from baseline
time frame: baseline, 12 weeks
measure: Change in LDL-cholesterol from baseline
time frame: baseline, 12 weeks
measure: Change in HDL-cholesterol from baseline
time frame: baseline, 12 weeks
measure: Change in Homeostasis Model Assessment-Insulin resistance(HOMA-IR) from baseline
time frame: baseline, 24 weeks
description: a marker of insulin resistance
measure: Change in Homeostasis Model Assessment - beta cell (HOMA-beta) from baseline
time frame: baseline, 24 weeks
description: a marker of beta cell function
measure: Change in highly sensitive C reactive protein(hs-CRP) from baseline
time frame: baseline, 24 weeks
description: a marker of inflammation
measure: Change in Plasmonogen activator inhibitor-1(PAI-1) from baseline
time frame: baseline, 24 weeks
measure: Change in B-type natriuretic pepetide(BNP) from baseline
time frame: baseline, 24 weeks
measure: event rate of hypoglycemia
time frame: upto 24 weeks
description: A number of total event of hypoglycemia defined as blood glucose <70mg/dL or subjective symptom of typical hypoglycemia
measure: No of subject with adverse event of special interest
time frame: upto 24 weeks
description: The event of special interest include
heart failure
cardiovascular effect other than heart failure
edema
weight gain
urinary bladder tumor
macular edema
fracture of bone
pancreatitis
measure: The number of serious adverse events
time frame: upto 24 weeks
measure: The number of subject with hypersensitivity to study drugs
time frame: upto 24 weeks
measure: The number of subject with any abnormality of laboratory evaluation
time frame: 12 week
description: Complete Blood count
BUN, Creatinine, AST, ALT, Calcium, Phosphorous, Sodium, Potassium, Total Protein, Albumin, Total Bilirubin, Gamma-glutamyl transferase, Alkaline phosphatase, Creatinine Kinase, amylase, lipase
Urine analysis including microscopic examination
measure: The number of subject with any abnormality of laboratory evaluation
time frame: 24 week
description: Complete Blood count
Blood urea nigrogen, Creatinine, Aspartate aminotransferase, Alanine Aminotransferase, Calcium, Phosphorous, Sodium, Potassium, Total Protein, Albumin, Total Bilirubin, Gamma-glutamyl transferase, Alkaline phosphatase, Creatinine Kinase, amylase, lipase
Urine analysis including microscopic examination
measure: The number of subject with any change of findings in Chest X-ray from baseline
time frame: 24 week
measure: The number of subject with any change of findings in electrocardiogram from baseline
time frame: 24 week
arm group label: alogliptin + pioglitazone
arm group type: Experimental
description: alogliptin 25 mg 1 tablet daily for 24 weeks pioglitazone 30 mg 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll
arm group label: alogliptin
arm group type: Active Comparator
description: alogliptin 25 mg 1 tablet daily for 24 weeks pioglitazone matching placebo 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll
arm group label: Pioglitazone
arm group type: Active Comparator
description: alogliptin matching placebo 1 tablet daily for 24 weeks pioglitazone 30 mg 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll
intervention type: Drug
intervention name: alogliptin
description: alogliptin 25 mg add-on background medication metformin
arm group label: alogliptin
other name: Nesina
intervention type: Drug
intervention name: Pioglitazone
description: pioglitazone 30 mg add-on background medication metformin
arm group label: Pioglitazone
other name: actos
intervention type: Drug
intervention name: alogliptin + pioglitazone
description: alogliptin 25 mg and pioglitazone 30 mg add-on background medication metformin
arm group label: alogliptin + pioglitazone
other name: Nesina
other name: Actos
criteria: 
gender: All
minimum age: 19 Years
maximum age: 75 Years
healthy volunteers: No
last name: Kun-Ho Yoon, MD, PhD
role: Principal Investigator
affiliation: Seoul St Mary's Hospital, The Catholic Univerisity of Korea
facility: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Kun-Ho Yoon
investigator title: Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Pioglitazone
mesh term: Alogliptin
sharing ipd: No