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Efficacy and Safety of Alogliptin Used Combination With Metformin 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 metformin
Alogliptin and metformin
Metformin
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

26 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
  2. Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
  3. Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
  4. Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

  1. Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
  2. With a history or symptoms of lactic acidosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Alogliptin 12.5 mg QD and metformin 500mg BID or 750mg TID

    Alogliptin 25mg QD and metformin 500mg BID or 750mg TID

    Metformin 500mg BID or 750mg TID

    Arm Description

    Outcomes

    Primary Outcome Measures

    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 or final visit and glycosylated hemoglobin collected at baseline.

    Secondary Outcome Measures

    Change From Baseline in Glycosylated Hemoglobin (Week 2).
    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 2 and glycosylated hemoglobin collected at baseline.
    Change From Baseline in Glycosylated Hemoglobin (Week 4).
    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 4 and glycosylated hemoglobin collected at baseline.
    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 Fasting Plasma Glucose (Week 2).
    The change between the value of fasting plasma glucose collected at week 2 and baseline.
    Change From Baseline in Fasting Plasma Glucose (Week 4).
    The change between the value of fasting plasma glucose collected at week 4 and baseline.
    Change From Baseline in Fasting Plasma Glucose (Week 8).
    The change between the value of fasting plasma glucose collected at week 8 and baseline.
    Change From Baseline in Fasting Plasma Glucose (Week 12).
    The change between the value of fasting plasma glucose collected at week 12 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 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.

    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
    NCT01318109
    Brief Title
    Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan
    Official Title
    A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Metformin 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
    August 2008 (undefined)
    Primary Completion Date
    April 2009 (Actual)
    Study Completion Date
    April 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 evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.
    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. The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to metformin in type 2 diabetic patients who have uncontrolled blood glucose despite treatment with metformin as well as diet and exercise therapies.

    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
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    288 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Alogliptin 12.5 mg QD and metformin 500mg BID or 750mg TID
    Arm Type
    Active Comparator
    Arm Title
    Alogliptin 25mg QD and metformin 500mg BID or 750mg TID
    Arm Type
    Active Comparator
    Arm Title
    Metformin 500mg BID or 750mg TID
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Alogliptin and metformin
    Other Intervention Name(s)
    SYR-32, Glycoran
    Intervention Description
    Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Alogliptin and metformin
    Other Intervention Name(s)
    SYR-322, Glycoran
    Intervention Description
    Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Other Intervention Name(s)
    Glycoran
    Intervention Description
    Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
    Primary Outcome Measure Information:
    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 or final visit and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 12.
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 2).
    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 2 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 2.
    Title
    Change From Baseline in Glycosylated Hemoglobin (Week 4).
    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 4 and glycosylated hemoglobin collected at baseline.
    Time Frame
    Baseline and Week 4.
    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 Fasting Plasma Glucose (Week 2).
    Description
    The change between the value of fasting plasma glucose collected at week 2 and baseline.
    Time Frame
    Baseline and Week 2.
    Title
    Change From Baseline in Fasting Plasma Glucose (Week 4).
    Description
    The change between the value of fasting plasma glucose collected at week 4 and baseline.
    Time Frame
    Baseline and Week 4.
    Title
    Change From Baseline in Fasting Plasma Glucose (Week 8).
    Description
    The change between the value of fasting plasma glucose collected at week 8 and baseline.
    Time Frame
    Baseline and Week 8.
    Title
    Change From Baseline in Fasting Plasma Glucose (Week 12).
    Description
    The change between the value of fasting plasma glucose collected at week 12 or final visit and baseline.
    Time Frame
    Baseline and Week 12.
    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 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 12.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    26 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0). Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4). Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place). Was receiving specific diet and exercise (if any) therapies during the observation period. Exclusion Criteria: Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0). With a history or symptoms of lactic acidosis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Professor, Diabetes and Endocrine Division
    Organizational Affiliation
    Department of Medicine, Kawasaki Medical School
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan

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