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Long-term Safety Study of Alogliptin 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
Alogliptin
Alogliptin
Alogliptin
Voglibose
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

29 Years - 87 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).

Exclusion Criteria:

  • Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
  • Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Alogliptin 6.25 mg QD

    Alogliptin 12.5 mg QD

    Alogliptin 25 mg QD

    Alogliptin 50 mg QD

    Voglibose 0.2-mg TID

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of Participants With Adverse Events.
    A treatment-emergent adverse event (TEAE) is defined as an adverse event 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, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below.

    Secondary 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 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 Plasma Glucose (Week 12).
    The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
    Change From Baseline in Fasting Plasma Glucose (Week 16).
    The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
    Change From Baseline in Fasting Plasma Glucose (Week 20).
    The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
    Change From Baseline in Fasting Plasma Glucose (Week 24).
    The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.
    Change From Baseline in Fasting Plasma Glucose (Week 28).
    The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.
    Change From Baseline in Fasting Plasma Glucose (Week 32).
    The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.
    Change From Baseline in Fasting Plasma Glucose (Week 36).
    The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.
    Change From Baseline in Fasting Plasma Glucose (Week 40).
    The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.
    Change From Baseline in Fasting Plasma Glucose (Week 44).
    The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.
    Change From Baseline in Fasting Plasma Glucose (Week 48).
    The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.
    Change From Baseline in Fasting Plasma Glucose (Week 52).
    The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.
    Change From Baseline in Fasting Plasma Glucose (Final Visit).
    The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.
    Change From Baseline in Fasting C-peptide (Week 12).
    The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.
    Change From Baseline in Fasting C-peptide (Week 16).
    The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.
    Change From Baseline in Fasting C-peptide (Week 20).
    The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.
    Change From Baseline in Fasting C-peptide (Week 24).
    The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.
    Change From Baseline in Fasting C-peptide (Week 28).
    The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.
    Change From Baseline in Fasting C-peptide (Week 32).
    The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.
    Change From Baseline in Fasting C-peptide (Week 36).
    The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.
    Change From Baseline in Fasting C-peptide (Week 40).
    The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.
    Change From Baseline in Fasting C-peptide (Week 44).
    The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.
    Change From Baseline in Fasting C-peptide (Week 48).
    The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.
    Change From Baseline in Fasting C-peptide (Week 52).
    The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.
    Change From Baseline in Fasting C-peptide (Final Visit).
    The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).
    The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).
    The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).
    The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).
    The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
    The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
    The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
    The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
    The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
    The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
    The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
    The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
    The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
    The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
    The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
    The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
    The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
    The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
    The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
    The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
    The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    Full Information

    First Posted
    December 17, 2010
    Last Updated
    February 1, 2012
    Sponsor
    Takeda
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01263496
    Brief Title
    Long-term Safety Study of Alogliptin 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 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 2007 (undefined)
    Primary Completion Date
    September 2008 (Actual)
    Study Completion Date
    September 2008 (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 SYR-322, once daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40 consecutive weeks in participants who completed a phase 2 dose-ranging 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, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who had completed the phase 2 dose-ranging study SYR-322/CCT-001 (NCT01263470).

    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
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    438 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Alogliptin 6.25 mg QD
    Arm Type
    Experimental
    Arm Title
    Alogliptin 12.5 mg QD
    Arm Type
    Experimental
    Arm Title
    Alogliptin 25 mg QD
    Arm Type
    Experimental
    Arm Title
    Alogliptin 50 mg QD
    Arm Type
    Experimental
    Arm Title
    Voglibose 0.2-mg TID
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Alogliptin
    Other Intervention Name(s)
    SYR-322
    Intervention Description
    Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Alogliptin
    Other Intervention Name(s)
    SYR-322
    Intervention Description
    Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Alogliptin
    Other Intervention Name(s)
    SYR-322
    Intervention Description
    Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Alogliptin
    Other Intervention Name(s)
    SYR-322
    Intervention Description
    Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Voglibose
    Other Intervention Name(s)
    Voglib, BASEN®
    Intervention Description
    Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Adverse Events.
    Description
    A treatment-emergent adverse event (TEAE) is defined as an adverse event 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, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below.
    Time Frame
    52 Weeks.
    Secondary 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 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 Plasma Glucose (Week 12).
    Description
    The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
    Time Frame
    Baseline and Week 12
    Title
    Change From Baseline in Fasting Plasma Glucose (Week 16).
    Description
    The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
    Time Frame
    Baseline and Week 16.
    Title
    Change From Baseline in Fasting Plasma Glucose (Week 20).
    Description
    The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
    Time Frame
    Baseline and Week 20.
    Title
    Change From Baseline in Fasting Plasma Glucose (Week 24).
    Description
    The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.
    Time Frame
    Baseline and Week 24.
    Title
    Change From Baseline in Fasting Plasma Glucose (Week 28).
    Description
    The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.
    Time Frame
    Baseline and Week 28.
    Title
    Change From Baseline in Fasting Plasma Glucose (Week 32).
    Description
    The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.
    Time Frame
    Baseline and Week 32.
    Title
    Change From Baseline in Fasting Plasma Glucose (Week 36).
    Description
    The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.
    Time Frame
    Baseline and Week 36.
    Title
    Change From Baseline in Fasting Plasma Glucose (Week 40).
    Description
    The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.
    Time Frame
    Baseline and Week 40.
    Title
    Change From Baseline in Fasting Plasma Glucose (Week 44).
    Description
    The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.
    Time Frame
    Baseline and Week 44.
    Title
    Change From Baseline in Fasting Plasma Glucose (Week 48).
    Description
    The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.
    Time Frame
    Baseline and Week 48.
    Title
    Change From Baseline in Fasting Plasma Glucose (Week 52).
    Description
    The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.
    Time Frame
    Baseline and Week 52.
    Title
    Change From Baseline in Fasting Plasma Glucose (Final Visit).
    Description
    The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.
    Time Frame
    Baseline and Final Visit (up to Week 52).
    Title
    Change From Baseline in Fasting C-peptide (Week 12).
    Description
    The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.
    Time Frame
    Baseline and Week 12.
    Title
    Change From Baseline in Fasting C-peptide (Week 16).
    Description
    The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.
    Time Frame
    Baseline and Week 16.
    Title
    Change From Baseline in Fasting C-peptide (Week 20).
    Description
    The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.
    Time Frame
    Baseline and Week 20.
    Title
    Change From Baseline in Fasting C-peptide (Week 24).
    Description
    The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.
    Time Frame
    Baseline and Week 24.
    Title
    Change From Baseline in Fasting C-peptide (Week 28).
    Description
    The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.
    Time Frame
    Baseline and Week 28.
    Title
    Change From Baseline in Fasting C-peptide (Week 32).
    Description
    The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.
    Time Frame
    Baseline and Week 32.
    Title
    Change From Baseline in Fasting C-peptide (Week 36).
    Description
    The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.
    Time Frame
    Baseline and Week 36.
    Title
    Change From Baseline in Fasting C-peptide (Week 40).
    Description
    The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.
    Time Frame
    Baseline and Week 40.
    Title
    Change From Baseline in Fasting C-peptide (Week 44).
    Description
    The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.
    Time Frame
    Baseline and Week 44.
    Title
    Change From Baseline in Fasting C-peptide (Week 48).
    Description
    The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.
    Time Frame
    Baseline and Week 48.
    Title
    Change From Baseline in Fasting C-peptide (Week 52).
    Description
    The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.
    Time Frame
    Baseline and Week 52.
    Title
    Change From Baseline in Fasting C-peptide (Final Visit).
    Description
    The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.
    Time Frame
    Baseline and Final Visit (up to Week 52).
    Title
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).
    Description
    The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 12.
    Title
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).
    Description
    The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 24.
    Title
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).
    Description
    The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 52.
    Title
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).
    Description
    The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Final Visit (up to Week 52).
    Title
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
    Description
    The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 12.
    Title
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
    Description
    The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 24.
    Title
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
    Description
    The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 52.
    Title
    Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
    Description
    The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Final Visit (up to Week 52).
    Title
    Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
    Description
    The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 12.
    Title
    Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
    Description
    The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 24.
    Title
    Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
    Description
    The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 52.
    Title
    Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
    Description
    The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Final Visit (up to Week 52).
    Title
    Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
    Description
    The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 12
    Title
    Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
    Description
    The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 24.
    Title
    Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
    Description
    The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 52.
    Title
    Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
    Description
    The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Final Visit (up to Week 52).
    Title
    Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
    Description
    The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 12
    Title
    Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
    Description
    The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 24.
    Title
    Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
    Description
    The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame
    Baseline and Week 52.
    Title
    Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
    Description
    The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 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
    29 Years
    Maximum Age & Unit of Time
    87 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12). Exclusion Criteria: Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study). Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Professor, Department of Medicine
    Organizational Affiliation
    Kawasaki Medical School
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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