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

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT01263470
Collaborator
(none)
480
Enrollment
1
Location
6
Arms
11
Duration (Months)
43.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.

Study Design

Study Type:
Interventional
Actual Enrollment :
480 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 in Subjects With Type 2 Diabetes in Japan
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Drug: Placebo
Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
Experimental: Alogliptin 6.25 mg QD

Drug: Alogliptin
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Other Names:
  • SYR-322

    		•
    Experimental: Alogliptin 12.5 mg QD

    Drug: Alogliptin
    Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
    Other Names:
  • SYR-322

    		•
    Experimental: Alogliptin 25 mg QD

    Drug: Alogliptin
    Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
    Other Names:
  • SYR-322

    		•
    Experimental: Alogliptin 50 mg QD

    Drug: Alogliptin
    Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks
    Other Names:
  • SYR-322

    		•
    Active Comparator: Voglibose 0.2 mg TID

    Drug: Voglibose
    Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Other Names:
  • Voglib
  • BASEN®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Glycosylated Hemoglobin (Week 12). [Baseline and 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

    1. Change From Baseline in Glycosylated Hemoglobin (Week 2). [Baseline and 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.

    2. Change From Baseline in Glycosylated Hemoglobin (Week 4). [Baseline and 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.

    3. Change From Baseline in Glycosylated Hemoglobin (Week 8). [Baseline and 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.

    4. Change From Baseline in Fasting Plasma Glucose (Week 2). [Baseline and Week 2]

      The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.

    5. Change From Baseline in Fasting Plasma Glucose (Week 4). [Baseline and Week 4.]

      The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.

    6. Change From Baseline in Fasting Plasma Glucose (Week 8). [Baseline and Week 8.]

      The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.

    7. Change From Baseline in Fasting Plasma Glucose (Week 12). [Baseline and Week 12.]

      The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.

    8. Change From Baseline in Fasting C-peptide (Week 2). [Baseline and Week 2.]

      The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.

    9. Change From Baseline in Fasting C-peptide (Week 4). [Baseline and Week 4.]

      The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.

    10. Change From Baseline in Fasting C-peptide (Week 8). [Baseline and Week 8.]

      The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.

    11. Change From Baseline in Fasting C-peptide (Week 12). [Baseline and Week 12.]

      The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.

    12. Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value). [Baseline and Week 12.]

      The change between the value of blood glucose collected at week 12 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 at 2 hours after the start of the meal.

    13. Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)). [Baseline and Week 12.]

      The change between the value of blood glucose collected at week 12 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 at 2 hours after the start of the meal.

    14. Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)). [Baseline and Week 12]

      The change between the value of insulin collected at week 12 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.

    15. Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2). [Baseline and Week 12.]

      The change between the value of C-peptide collected at week 12 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.

    16. Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)). [Baseline and Week 12]

      The change between the value of glucagons collected at week 12 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).

    • A HbA1c differences within 10.0%* (*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.

    • Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

    Exclusion Criteria:
    • Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Okayama Japan 701-0192

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Professor, Department of Medicine, Kawasaki Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT01263470
    Other Study ID Numbers:
    • SYR-322/CCT-001
    • U1111-1118-3752
    First Posted:
    Dec 20, 2010
    Last Update Posted:
    Feb 3, 2012
    Last Verified:
    Feb 1, 2012
    Keywords provided by Takeda
    Diabetes Mellitus - Type 2
    Diabetes Mellitus
    Drug Therapy
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Alogliptin
    Voglibose

    Study Results

    Participant Flow

    Recruitment Details Participants enrolled at 54 investigative sites in Japan from 17 January 2007 to 22 December 2007.
    Pre-assignment Detail Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite diet and exercise therapies were enrolled in one of 6, once-daily (QD) or three-times daily (TID) treatment groups.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Period Title: Overall Study
    STARTED 75 79 84 80 79 83
    COMPLETED 73 74 80 77 76 78
    NOT COMPLETED 2 5 4 3 3 5

    Baseline Characteristics

    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID Total
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. Total of all reporting groups
    Overall Participants 75 79 84 80 79 83 480
    Age, Customized (participants) [Number]
    ≤ 64 years
    48
    64%
    58
    73.4%
    56
    66.7%
    52
    65%
    54
    68.4%
    51
    61.4%
    319
    66.5%
    ≥ 65 years
    27
    36%
    21
    26.6%
    28
    33.3%
    28
    35%
    25
    31.6%
    32
    38.6%
    161
    33.5%
    Sex: Female, Male (Count of Participants)
    Female
    19
    25.3%
    23
    29.1%
    25
    29.8%
    17
    21.3%
    24
    30.4%
    27
    32.5%
    135
    28.1%
    Male
    56
    74.7%
    56
    70.9%
    59
    70.2%
    63
    78.8%
    55
    69.6%
    56
    67.5%
    345
    71.9%

    Outcome Measures

    1. Primary Outcome
    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.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 75 79 84 79 79 83
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    0.06
    (0.456)
    -0.51
    (0.677)
    -0.70
    (0.572)
    -0.76
    (0.547)
    -0.82
    (0.474)
    -0.16
    (0.730)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.570
    Confidence Interval (2-Sided) 95%
    -0.755 to -0.386
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.762
    Confidence Interval (2-Sided) 95%
    -0.925 to -0.598
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.826
    Confidence Interval (2-Sided) 95%
    -0.987 to -0.665
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.887
    Confidence Interval (2-Sided) 95%
    -1.035 to -0.739
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.351
    Confidence Interval (2-Sided) 95%
    -0.570 to -0.132
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.542
    Confidence Interval (2-Sided) 95%
    -0.743 to -0.342
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.607
    Confidence Interval (2-Sided) 95%
    -0.808 to -0.406
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.667
    Confidence Interval (2-Sided) 95%
    -0.859 to -0.475
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    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.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 75 79 84 79 79 83
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    0.00
    (0.187)
    -0.16
    (0.153)
    -0.17
    (0.194)
    -0.16
    (0.187)
    -0.15
    (0.180)
    -0.10
    (0.204)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.158
    Confidence Interval (2-Sided) 95%
    -0.213 to -0.104
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.174
    Confidence Interval (2-Sided) 95%
    -0.234 to -0.114
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.160
    Confidence Interval (2-Sided) 95%
    -0.219 to -0.100
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.153
    Confidence Interval (2-Sided) 95%
    -0.212 to -0.095
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.059
    Confidence Interval (2-Sided) 95%
    -0.116 to -0.003
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.075
    Confidence Interval (2-Sided) 95%
    -0.136 to -0.014
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.061
    Confidence Interval (2-Sided) 95%
    -0.121 to 0.000
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.054
    Confidence Interval (2-Sided) 95%
    -0.114 to 0.006
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    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.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 75 79 84 79 79 83
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    -0.01
    (0.336)
    -0.34
    (0.243)
    -0.38
    (0.309)
    -0.35
    (0.281)
    -0.40
    (0.284)
    -0.16
    (0.395)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.326
    Confidence Interval (2-Sided) 95%
    -0.419 to -0.233
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.369
    Confidence Interval (2-Sided) 95%
    -0.470 to -0.268
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.340
    Confidence Interval (2-Sided) 95%
    -0.438 to -0.241
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.387
    Confidence Interval (2-Sided) 95%
    -0.485 to -0.288
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.178
    Confidence Interval (2-Sided) 95%
    -0.280 to -0.076
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.221
    Confidence Interval (2-Sided) 95%
    -0.329 to -0.112
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.192
    Confidence Interval (2-Sided) 95%
    -0.299 to -0.085
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.239
    Confidence Interval (2-Sided) 95%
    -0.346 to -0.131
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    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.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 75 79 84 79 79 83
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    0.00
    (0.473)
    -0.50
    (0.432)
    -0.61
    (0.481)
    -0.66
    (0.432)
    -0.69
    (0.382)
    -0.17
    (0.634)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.500
    Confidence Interval (2-Sided) 95%
    -0.644 to -0.356
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.614
    Confidence Interval (2-Sided) 95%
    -0.763 to -0.464
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.660
    Confidence Interval (2-Sided) 95%
    -0.804 to -0.516
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.695
    Confidence Interval (2-Sided) 95%
    -0.832 to -0.559
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.325
    Confidence Interval (2-Sided) 95%
    -0.494 to -0.156
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.438
    Confidence Interval (2-Sided) 95%
    -0.610 to -0.267
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.485
    Confidence Interval (2-Sided) 95%
    -0.654 to -0.315
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.520
    Confidence Interval (2-Sided) 95%
    -0.683 to -0.357
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    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 fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 2

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 75 79 84 79 79 83
    Mean (Standard Deviation) [mg/dL]
    1.8
    (28.26)
    -13.8
    (19.31)
    -15.9
    (20.26)
    -14.3
    (22.13)
    -21.7
    (25.65)
    -8.0
    (24.34)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -15.60
    Confidence Interval (2-Sided) 95%
    -23.27 to -7.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -17.69
    Confidence Interval (2-Sided) 95%
    -25.34 to -10.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -16.08
    Confidence Interval (2-Sided) 95%
    -24.14 to -8.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -23.47
    Confidence Interval (2-Sided) 95%
    -32.06 to -14.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -5.82
    Confidence Interval (2-Sided) 95%
    -12.66 to 1.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.92
    Confidence Interval (2-Sided) 95%
    -14.76 to -1.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.30
    Confidence Interval (2-Sided) 95%
    -13.53 to 0.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -13.69
    Confidence Interval (2-Sided) 95%
    -21.45 to -5.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    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 fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 4.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 75 79 84 79 79 83
    Mean (Standard Deviation) [mg/dL]
    8.4
    (30.74)
    -16.0
    (20.88)
    -20.9
    (19.78)
    -19.0
    (20.64)
    -23.3
    (23.40)
    -7.2
    (26.77)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -15.60
    Confidence Interval (2-Sided) 95%
    -23.27 to -7.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -17.69
    Confidence Interval (2-Sided) 95%
    -25.34 to -10.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -16.08
    Confidence Interval (2-Sided) 95%
    -24.14 to -8.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -23.47
    Confidence Interval (2-Sided) 95%
    -32.06 to -14.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -5.82
    Confidence Interval (2-Sided) 95%
    -12.66 to 1.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.92
    Confidence Interval (2-Sided) 95%
    -14.76 to -1.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.30
    Confidence Interval (2-Sided) 95%
    -13.53 to 0.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -13.69
    Confidence Interval (2-Sided) 95%
    -21.45 to -5.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    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 fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 8.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 75 79 84 79 79 83
    Mean (Standard Deviation) [mg/dL]
    5.7
    (27.40)
    -12.0
    (27.77)
    -18.5
    (22.71)
    -18.6
    (20.58)
    -22.6
    (27.60)
    -3.5
    (28.45)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -17.73
    Confidence Interval (2-Sided) 95%
    -26.52 to -8.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -24.22
    Confidence Interval (2-Sided) 95%
    -32.07 to -16.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -24.34
    Confidence Interval (2-Sided) 95%
    -32.03 to -16.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -28.28
    Confidence Interval (2-Sided) 95%
    -37.04 to -19.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -8.55
    Confidence Interval (2-Sided) 95%
    -17.28 to 0.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -15.04
    Confidence Interval (2-Sided) 95%
    -22.90 to -7.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -15.16
    Confidence Interval (2-Sided) 95%
    -22.90 to -7.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -19.10
    Confidence Interval (2-Sided) 95%
    -27.80 to -10.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    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 fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 12.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 75 79 84 79 79 83
    Mean (Standard Deviation) [mg/dL]
    5.6
    (25.26)
    -9.3
    (32.36)
    -14.6
    (23.80)
    -17.5
    (20.71)
    -22.6
    (24.24)
    -3.0
    (27.69)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -14.92
    Confidence Interval (2-Sided) 95%
    -24.19 to -5.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -20.17
    Confidence Interval (2-Sided) 95%
    -27.86 to -12.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -23.07
    Confidence Interval (2-Sided) 95%
    -30.41 to -15.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -28.17
    Confidence Interval (2-Sided) 95%
    -36.05 to -20.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.27
    Confidence Interval (2-Sided) 95%
    -15.60 to 3.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -11.52
    Confidence Interval (2-Sided) 95%
    -19.41 to -3.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -14.42
    Confidence Interval (2-Sided) 95%
    -22.04 to -6.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -19.52
    Confidence Interval (2-Sided) 95%
    -27.61 to -11.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 2).
    Description The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 2.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 75 79 84 79 79 83
    Mean (Standard Deviation) [ng/mL]
    0.04
    (0.772)
    -0.11
    (0.731)
    0.17
    (0.756)
    0.18
    (0.776)
    0.04
    (0.619)
    -0.11
    (0.830)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.145
    Confidence Interval (2-Sided) 95%
    -0.384 to 0.094
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.134
    Confidence Interval (2-Sided) 95%
    -0.106 to 0.374
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.144
    Confidence Interval (2-Sided) 95%
    -0.103 to 0.390
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.004
    Confidence Interval (2-Sided) 95%
    -0.218 to 0.227
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.002
    Confidence Interval (2-Sided) 95%
    -0.241 to 0.245
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.281
    Confidence Interval (2-Sided) 95%
    0.038 to 0.524
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.291
    Confidence Interval (2-Sided) 95%
    0.041 to 0.540
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.151
    Confidence Interval (2-Sided) 95%
    -0.077 to 0.380
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 4).
    Description The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 4.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 75 79 84 79 79 83
    Mean (Standard Deviation) [ng/mL]
    0.01
    (0.624)
    -0.04
    (0.634)
    0.02
    (0.636)
    0.16
    (0.697)
    0.05
    (0.554)
    -0.16
    (0.767)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.045
    Confidence Interval (2-Sided) 95%
    -0.245 to 0.156
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.012
    Confidence Interval (2-Sided) 95%
    -0.185 to 0.210
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.158
    Confidence Interval (2-Sided) 95%
    -0.053 to 0.369
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.048
    Confidence Interval (2-Sided) 95%
    -0.140 to 0.235
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.122
    Confidence Interval (2-Sided) 95%
    -0.097 to 0.341
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.179
    Confidence Interval (2-Sided) 95%
    -0.036 to 0.395
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.325
    Confidence Interval (2-Sided) 95%
    0.097 to 0.553
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.215
    Confidence Interval (2-Sided) 95%
    0.006 to 0.423
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 8).
    Description The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 8.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 75 79 84 79 79 83
    Mean (Standard Deviation) [ng/mL]
    0.17
    (0.882)
    0.05
    (1.144)
    0.07
    (0.792)
    0.24
    (0.646)
    0.05
    (0.592)
    -0.05
    (0.804)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.117
    Confidence Interval (2-Sided) 95%
    -0.444 to 0.209
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.100
    Confidence Interval (2-Sided) 95%
    -0.362 to 0.162
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.079
    Confidence Interval (2-Sided) 95%
    -0.166 to 0.324
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.117
    Confidence Interval (2-Sided) 95%
    -0.355 to 0.121
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.102
    Confidence Interval (2-Sided) 95%
    -0.203 to 0.408
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.120
    Confidence Interval (2-Sided) 95%
    -0.124 to 0.364
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.299
    Confidence Interval (2-Sided) 95%
    0.071 to 0.526
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.102
    Confidence Interval (2-Sided) 95%
    -0.118 to 0.322
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    12. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 12).
    Description The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 12.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 75 79 84 79 79 83
    Mean (Standard Deviation) [ng/mL]
    -0.00
    (0.692)
    0.04
    (0.967)
    0.17
    (0.609)
    0.25
    (0.591)
    0.18
    (0.696)
    -0.02
    (0.888)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.039
    Confidence Interval (2-Sided) 95%
    -0.230 to 0.308
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.175
    Confidence Interval (2-Sided) 95%
    -0.029 to 0.379
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.248
    Confidence Interval (2-Sided) 95%
    0.044 to 0.453
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.186
    Confidence Interval (2-Sided) 95%
    -0.035 to 0.407
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.052
    Confidence Interval (2-Sided) 95%
    -0.236 to 0.340
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.188
    Confidence Interval (2-Sided) 95%
    -0.044 to 0.421
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.261
    Confidence Interval (2-Sided) 95%
    0.026 to 0.496
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.199
    Confidence Interval (2-Sided) 95%
    -0.049 to 0.448
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).
    Description The change between the value of blood glucose collected at week 12 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 at 2 hours after the start of the meal.
    Time Frame Baseline and Week 12.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 73 76 80 78 76 79
    Mean (Standard Deviation) [mg/dL]
    -4.2
    (42.10)
    -28.1
    (49.50)
    -27.6
    (43.88)
    -44.8
    (36.04)
    -47.0
    (32.66)
    -22.7
    (40.58)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -23.85
    Confidence Interval (2-Sided) 95%
    -38.75 to -8.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -23.38
    Confidence Interval (2-Sided) 95%
    -37.14 to -9.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -40.60
    Confidence Interval (2-Sided) 95%
    -53.18 to -28.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -42.75
    Confidence Interval (2-Sided) 95%
    -54.93 to -30.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -5.36
    Confidence Interval (2-Sided) 95%
    -19.70 to 8.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -4.89
    Confidence Interval (2-Sided) 95%
    -18.13 to 8.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -22.11
    Confidence Interval (2-Sided) 95%
    -34.22 to -10.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -24.27
    Confidence Interval (2-Sided) 95%
    -35.98 to -12.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. Secondary Outcome
    Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).
    Description The change between the value of blood glucose collected at week 12 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 at 2 hours after the start of the meal.
    Time Frame Baseline and Week 12.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 73 76 80 78 76 79
    Mean (Standard Deviation) [mg·hr/dL]
    5.6
    (62.45)
    -52.7
    (75.51)
    -55.0
    (63.73)
    -73.1
    (51.21)
    -81.8
    (53.69)
    -50.0
    (62.49)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -58.31
    Confidence Interval (2-Sided) 95%
    -80.79 to -35.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -60.66
    Confidence Interval (2-Sided) 95%
    -80.84 to -40.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -78.72
    Confidence Interval (2-Sided) 95%
    -97.03 to -60.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -87.43
    Confidence Interval (2-Sided) 95%
    -106.26 to -68.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.73
    Confidence Interval (2-Sided) 95%
    -24.69 to 19.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -5.07
    Confidence Interval (2-Sided) 95%
    -24.85 to 14.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -23.13
    Confidence Interval (2-Sided) 95%
    -41.16 to -5.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -31.84
    Confidence Interval (2-Sided) 95%
    -50.36 to -13.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. Secondary Outcome
    Title Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).
    Description The change between the value of insulin collected at week 12 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 Week 12

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 69 71 78 70 72 68
    Mean (Standard Deviation) [μU·hr/mL]
    -3.60
    (12.940)
    -0.74
    (19.745)
    1.86
    (15.602)
    4.12
    (14.057)
    -1.04
    (23.333)
    -15.40
    (20.416)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.859
    Confidence Interval (2-Sided) 95%
    -2.736 to 8.455
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.456
    Confidence Interval (2-Sided) 95%
    0.748 to 10.165
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 7.715
    Confidence Interval (2-Sided) 95%
    3.181 to 12.248
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.557
    Confidence Interval (2-Sided) 95%
    -3.763 to 8.877
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 14.660
    Confidence Interval (2-Sided) 95%
    7.924 to 21.396
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 17.257
    Confidence Interval (2-Sided) 95%
    11.353 to 23.160
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 19.515
    Confidence Interval (2-Sided) 95%
    13.629 to 25.401
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 14.357
    Confidence Interval (2-Sided) 95%
    7.013 to 21.701
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).
    Description The change between the value of C-peptide collected at week 12 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 Week 12.

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 73 76 80 78 76 79
    Mean (Standard Deviation) [ng·hr/mL]
    0.01
    (1.628)
    0.54
    (1.787)
    0.77
    (1.804)
    1.01
    (1.957)
    0.97
    (1.642)
    -0.39
    (2.091)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.535
    Confidence Interval (2-Sided) 95%
    -0.019 to 1.089
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.764
    Confidence Interval (2-Sided) 95%
    0.214 to 1.315
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.999
    Confidence Interval (2-Sided) 95%
    0.418 to 1.580
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.959
    Confidence Interval (2-Sided) 95%
    0.430 to 1.489
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.934
    Confidence Interval (2-Sided) 95%
    0.315 to 1.552
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.163
    Confidence Interval (2-Sided) 95%
    0.551 to 1.774
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.398
    Confidence Interval (2-Sided) 95%
    0.759 to 2.036
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.358
    Confidence Interval (2-Sided) 95%
    0.760 to 1.956
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    17. Secondary Outcome
    Title Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).
    Description The change between the value of glucagons collected at week 12 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 Week 12

    Outcome Measure Data

    Analysis Population Description
    Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    Measure Participants 72 75 79 78 76 79
    Mean (Standard Deviation) [pg·hr/mL]
    -15.8
    (36.91)
    -11.5
    (37.45)
    -4.5
    (38.54)
    -12.6
    (47.23)
    -19.5
    (40.47)
    -16.3
    (52.26)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 6.25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.25
    Confidence Interval (2-Sided) 95%
    -7.87 to 16.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 11.26
    Confidence Interval (2-Sided) 95%
    -0.90 to 23.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.19
    Confidence Interval (2-Sided) 95%
    -10.56 to 16.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 50 mg QD
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -3.66
    Confidence Interval (2-Sided) 95%
    -16.27 to 8.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Alogliptin 6.25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.75
    Confidence Interval (2-Sided) 95%
    -9.79 to 19.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 11.76
    Confidence Interval (2-Sided) 95%
    -2.67 to 26.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.69
    Confidence Interval (2-Sided) 95%
    -12.02 to 19.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Alogliptin 50 mg QD, Voglibose 0.2 mg TID
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -3.17
    Confidence Interval (2-Sided) 95%
    -18.04 to 11.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug.
    Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Arm/Group Title Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Arm/Group Description Placebo-matching tablets, orally, once or three times daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
    All Cause Mortality
    Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/75 (1.3%) 2/79 (2.5%) 2/84 (2.4%) 1/80 (1.3%) 2/79 (2.5%) 2/83 (2.4%)
    Gastrointestinal disorders
    Crohn's disease 0/75 (0%) 0/79 (0%) 0/84 (0%) 1/80 (1.3%) 0/79 (0%) 0/83 (0%)
    Inguinal hernia 0/75 (0%) 0/79 (0%) 1/84 (1.2%) 0/80 (0%) 0/79 (0%) 0/83 (0%)
    Hepatobiliary disorders
    Bile duct stone 1/75 (1.3%) 0/79 (0%) 0/84 (0%) 0/80 (0%) 0/79 (0%) 0/83 (0%)
    Cholelithiasis 0/75 (0%) 0/79 (0%) 1/84 (1.2%) 0/80 (0%) 0/79 (0%) 0/83 (0%)
    Infections and infestations
    Gastroenteritis 0/75 (0%) 0/79 (0%) 0/84 (0%) 0/80 (0%) 1/79 (1.3%) 0/83 (0%)
    Pneumonia 0/75 (0%) 0/79 (0%) 0/84 (0%) 0/80 (0%) 0/79 (0%) 1/83 (1.2%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Meningioma 0/75 (0%) 1/79 (1.3%) 0/84 (0%) 0/80 (0%) 0/79 (0%) 0/83 (0%)
    Papillary thyroid cancer 0/75 (0%) 0/79 (0%) 0/84 (0%) 0/80 (0%) 1/79 (1.3%) 0/83 (0%)
    Breast cancer female 0/75 (0%) 0/79 (0%) 0/84 (0%) 0/80 (0%) 0/79 (0%) 1/83 (1.2%)
    Nervous system disorders
    Cerebral infarction 0/75 (0%) 1/79 (1.3%) 0/84 (0%) 0/80 (0%) 0/79 (0%) 0/83 (0%)
    Other (Not Including Serious) Adverse Events
    Placebo Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Voglibose 0.2 mg TID
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 20/75 (26.7%) 17/79 (21.5%) 23/84 (27.4%) 27/80 (33.8%) 23/79 (29.1%) 38/83 (45.8%)
    Gastrointestinal disorders
    Flatulence 2/75 (2.7%) 2/79 (2.5%) 4/84 (4.8%) 1/80 (1.3%) 1/79 (1.3%) 8/83 (9.6%)
    Abdominal distension 0/75 (0%) 1/79 (1.3%) 2/84 (2.4%) 3/80 (3.8%) 2/79 (2.5%) 4/83 (4.8%)
    Constipation 1/75 (1.3%) 1/79 (1.3%) 1/84 (1.2%) 1/80 (1.3%) 1/79 (1.3%) 7/83 (8.4%)
    Abdominal pain upper 0/75 (0%) 1/79 (1.3%) 1/84 (1.2%) 3/80 (3.8%) 2/79 (2.5%) 1/83 (1.2%)
    Diarrhoea 2/75 (2.7%) 0/79 (0%) 1/84 (1.2%) 0/80 (0%) 1/79 (1.3%) 3/83 (3.6%)
    Gastritis 3/75 (4%) 0/79 (0%) 0/84 (0%) 0/80 (0%) 0/79 (0%) 3/83 (3.6%)
    General disorders
    Malaise 0/75 (0%) 0/79 (0%) 0/84 (0%) 3/80 (3.8%) 0/79 (0%) 0/83 (0%)
    Infections and infestations
    Nasopharyngitis 5/75 (6.7%) 5/79 (6.3%) 7/84 (8.3%) 10/80 (12.5%) 8/79 (10.1%) 4/83 (4.8%)
    Bronchitis 1/75 (1.3%) 3/79 (3.8%) 2/84 (2.4%) 0/80 (0%) 2/79 (2.5%) 0/83 (0%)
    Investigations
    Blood creatine phosphokinase increased 2/75 (2.7%) 1/79 (1.3%) 2/84 (2.4%) 1/80 (1.3%) 4/79 (5.1%) 4/83 (4.8%)
    Metabolism and nutrition disorders
    Hyperlipidaemia 0/75 (0%) 1/79 (1.3%) 0/84 (0%) 0/80 (0%) 1/79 (1.3%) 3/83 (3.6%)
    Nervous system disorders
    Headache 4/75 (5.3%) 2/79 (2.5%) 0/84 (0%) 5/80 (6.3%) 0/79 (0%) 1/83 (1.2%)
    Skin and subcutaneous tissue disorders
    Urticaria 0/75 (0%) 0/79 (0%) 3/84 (3.6%) 0/80 (0%) 1/79 (1.3%) 0/83 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.

    Results Point of Contact

    Name/Title General Manager
    Organization Japan Development Center, Pharmaceutical Development Division
    Phone +81-6-6204-5257
    Email clinicaltrialregistry@tpna.com
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT01263470
    Other Study ID Numbers:
    • SYR-322/CCT-001
    • U1111-1118-3752
    First Posted:
    Dec 20, 2010
    Last Update Posted:
    Feb 3, 2012
    Last Verified:
    Feb 1, 2012