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Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Alogliptin and pioglitazone
Alogliptin and pioglitazone
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes Mellitus - Type 2, Diabetes Mellitus, Drug Therapy

Eligibility Criteria

33 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Had completed the core phase 2/3 thiazolidine add on study.
  2. The subject was capable of understanding and complying with protocol requirements.
  3. Signed a written, informed consent form prior to the initiation of any study procedure.

Exclusion Criteria:

  1. With clinical manifestation of hepatic impairment (e.g., an AST or ALT value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 thiazolidine add on study).
  2. With clinical manifestation of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of the core phase 2/3 thiazolidine add on study).
  3. With a history or symptoms of cardiac failure.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD

    Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of Participants With Adverse Events.
    Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.

    Secondary Outcome Measures

    Change From Baseline in Glycosylated Hemoglobin (Week 8).
    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 week 8 and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Glycosylated Hemoglobin (Week 12).
    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 week 12 and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Glycosylated Hemoglobin (Week 16).
    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 week 16 and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Glycosylated Hemoglobin (Week 20).
    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 week 20 and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Glycosylated Hemoglobin (Week 24).
    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 week 24 and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Glycosylated Hemoglobin (Week 28).
    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 week 28 and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Glycosylated Hemoglobin (Week 32).
    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 week 32 and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Glycosylated Hemoglobin (Week 36).
    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 week 36 and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Glycosylated Hemoglobin (Week 40).
    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 week 40 and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Glycosylated Hemoglobin (Week 44).
    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 week 44 and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Glycosylated Hemoglobin (Week 48).
    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 week 48 and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Glycosylated Hemoglobin (Week 52).
    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 week 52 and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Glycosylated Hemoglobin (Final Visit).
    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 week 52 or final visit and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Fasting Blood Glucose (Week 8).
    The change between the value of fasting blood glucose collected at week 8 and baseline.
    Change From Baseline in Fasting Blood Glucose (Week 12).
    The change between the value of fasting blood glucose collected at week 12 and baseline.
    Change From Baseline in Fasting Blood Glucose (Week 16).
    The change between the value of fasting blood glucose collected at week 6 and baseline.
    Change From Baseline in Fasting Blood Glucose (Week 20).
    The change between the value of fasting blood glucose collected at week 20 and baseline.
    Change From Baseline in Fasting Blood Glucose (Week 24).
    The change between the value of fasting blood glucose collected at week 24 and baseline.
    Change From Baseline in Fasting Blood Glucose (Week 28).
    The change between the value of fasting blood glucose collected at week 28 and baseline.
    Change From Baseline in Fasting Blood Glucose (Week 32).
    The change between the value of fasting blood glucose collected at week 32 and baseline.
    Change From Baseline in Fasting Blood Glucose (Week 36).
    The change between the value of fasting blood glucose collected at week 36 and baseline.
    Change From Baseline in Fasting Blood Glucose (Week 40).
    The change between the value of fasting blood glucose collected at week 40 and baseline.
    Change From Baseline in Fasting Blood Glucose (Week 44).
    The change between the value of fasting blood glucose collected at week 44 and baseline.
    Change From Baseline in Fasting Blood Glucose (Week 48).
    The change between the value of fasting blood glucose collected at week 48 and baseline.
    Change From Baseline in Fasting Blood Glucose (Week 52).
    The change between the value of fasting blood glucose collected at week 52 and baseline.
    Change From Baseline in Fasting Blood Glucose (Final Visit).
    The change between the value of fasting blood glucose collected at week 52 or final visit and baseline.
    Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
    The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
    Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).
    The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
    Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).
    The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
    Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).
    The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or end of study and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.

    Full Information

    First Posted
    March 16, 2011
    Last Updated
    February 1, 2012
    Sponsor
    Takeda
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01318122
    Brief Title
    Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
    Official Title
    A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR-322 When Used in Combination With Thiazolidine in Subjects With Type 2 Diabetes in Japan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    August 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Takeda

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who completed a phase 2/3 Thiazolidine add on study.
    Detailed Description
    Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes. To evaluate the long-term safety and efficacy of alogliptin, participants in the present study were enrolled from a core phase 2/3 thiazolidine add on study (SYR-322/CCT-004; NCT01318070).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    Diabetes Mellitus - Type 2, Diabetes Mellitus, Drug Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    336 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
    Arm Type
    Active Comparator
    Arm Title
    Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Alogliptin and pioglitazone
    Other Intervention Name(s)
    SYR-322, Actos
    Intervention Description
    Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Alogliptin and pioglitazone
    Other Intervention Name(s)
    SYR-322, Actos
    Intervention Description
    Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Adverse Events.
    Description
    Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
    Time Frame
    52 Weeks.
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 8).
    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 week 8 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 8.
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 12).
    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 week 12 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 12.
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 16).
    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 week 16 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 16.
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 20).
    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 week 20 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 20.
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 24).
    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 week 24 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 24.
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 28).
    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 week 28 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 28.
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 32).
    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 week 32 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 32.
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 36).
    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 week 36 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 36.
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 40).
    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 week 40 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 40.
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 44).
    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 week 44 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 44.
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 48).
    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 week 48 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 48.
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 52).
    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 week 52 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 52.
    Title
    Change From Baseline in Glycosylated Hemoglobin (Final Visit).
    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 week 52 or final visit and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Final Visit (up to Week 52).
    Title
    Change From Baseline in Fasting Blood Glucose (Week 8).
    Description
    The change between the value of fasting blood glucose collected at week 8 and baseline.
    Time Frame
    Baseline and Week 8.
    Title
    Change From Baseline in Fasting Blood Glucose (Week 12).
    Description
    The change between the value of fasting blood glucose collected at week 12 and baseline.
    Time Frame
    Baseline and Week 12.
    Title
    Change From Baseline in Fasting Blood Glucose (Week 16).
    Description
    The change between the value of fasting blood glucose collected at week 6 and baseline.
    Time Frame
    Baseline and Week 16.
    Title
    Change From Baseline in Fasting Blood Glucose (Week 20).
    Description
    The change between the value of fasting blood glucose collected at week 20 and baseline.
    Time Frame
    Baseline and Week 20.
    Title
    Change From Baseline in Fasting Blood Glucose (Week 24).
    Description
    The change between the value of fasting blood glucose collected at week 24 and baseline.
    Time Frame
    Baseline and Week 24.
    Title
    Change From Baseline in Fasting Blood Glucose (Week 28).
    Description
    The change between the value of fasting blood glucose collected at week 28 and baseline.
    Time Frame
    Baseline and Week 28.
    Title
    Change From Baseline in Fasting Blood Glucose (Week 32).
    Description
    The change between the value of fasting blood glucose collected at week 32 and baseline.
    Time Frame
    Baseline and Week 32.
    Title
    Change From Baseline in Fasting Blood Glucose (Week 36).
    Description
    The change between the value of fasting blood glucose collected at week 36 and baseline.
    Time Frame
    Baseline and Week 36.
    Title
    Change From Baseline in Fasting Blood Glucose (Week 40).
    Description
    The change between the value of fasting blood glucose collected at week 40 and baseline.
    Time Frame
    Baseline and Week 40.
    Title
    Change From Baseline in Fasting Blood Glucose (Week 44).
    Description
    The change between the value of fasting blood glucose collected at week 44 and baseline.
    Time Frame
    Baseline and Week 44.
    Title
    Change From Baseline in Fasting Blood Glucose (Week 48).
    Description
    The change between the value of fasting blood glucose collected at week 48 and baseline.
    Time Frame
    Baseline and Week 48.
    Title
    Change From Baseline in Fasting Blood Glucose (Week 52).
    Description
    The change between the value of fasting blood glucose collected at week 52 and baseline.
    Time Frame
    Baseline and Week 52.
    Title
    Change From Baseline in Fasting Blood Glucose (Final Visit).
    Description
    The change between the value of fasting blood glucose collected at week 52 or final visit and baseline.
    Time Frame
    Baseline and Final Visit (up to Week 52).
    Title
    Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
    Description
    The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 12.
    Title
    Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).
    Description
    The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 24.
    Title
    Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).
    Description
    The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 52.
    Title
    Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).
    Description
    The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or end of study and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
    Time Frame
    Baseline and Final Visit (up to Week 52).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    33 Years
    Maximum Age & Unit of Time
    88 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Had completed the core phase 2/3 thiazolidine add on study. The subject was capable of understanding and complying with protocol requirements. Signed a written, informed consent form prior to the initiation of any study procedure. Exclusion Criteria: With clinical manifestation of hepatic impairment (e.g., an AST or ALT value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 thiazolidine add on study). With clinical manifestation of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of the core phase 2/3 thiazolidine add on study). With a history or symptoms of cardiac failure.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Professor, Department of Medicine
    Organizational Affiliation
    Department of Medicine, Kawasaki Medical School
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan

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