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

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT01263496
Collaborator
(none)
438
Enrollment
5
Arms
16.1
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40 consecutive weeks in participants who completed a phase 2 dose-ranging study.

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, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who had completed the phase 2 dose-ranging study SYR-322/CCT-001 (NCT01263470).

Study Design

Study Type:
Interventional
Actual Enrollment :
438 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Long-term, Open-label Extension Study to Investigate the Long-term Safety of SYR-322 in Subjects With Type 2 Diabetes in Japan.
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alogliptin 6.25 mg QD

Drug: Alogliptin
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
Other Names:
  • SYR-322

    		•
    Experimental: Alogliptin 12.5 mg QD

    Drug: Alogliptin
    Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
    Other Names:
  • SYR-322

    		•
    Experimental: Alogliptin 25 mg QD

    Drug: Alogliptin
    Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
    Other Names:
  • SYR-322

    		•
    Experimental: Alogliptin 50 mg QD

    Drug: Alogliptin
    Alogliptin 50 mg, tablets, orally, once daily for up to 40 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 40 weeks.
    Other Names:
  • Voglib
  • BASEN®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events. [52 Weeks.]

      A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below.

    Secondary Outcome Measures

    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 and glycosylated hemoglobin collected at baseline.

    2. Change From Baseline in Glycosylated Hemoglobin (Week 16). [Baseline and Week 16.]

      The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.

    3. Change From Baseline in Glycosylated Hemoglobin (Week 20). [Baseline and Week 20.]

      The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.

    4. Change From Baseline in Glycosylated Hemoglobin (Week 24). [Baseline and Week 24.]

      The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.

    5. Change From Baseline in Glycosylated Hemoglobin (Week 28). [Baseline and Week 28.]

      The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.

    6. Change From Baseline in Glycosylated Hemoglobin (Week 32). [Baseline and Week 32.]

      The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.

    7. Change From Baseline in Glycosylated Hemoglobin (Week 36). [Baseline and Week 36.]

      The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.

    8. Change From Baseline in Glycosylated Hemoglobin (Week 40). [Baseline and Week 40.]

      The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.

    9. Change From Baseline in Glycosylated Hemoglobin (Week 44). [Baseline and Week 44.]

      The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.

    10. Change From Baseline in Glycosylated Hemoglobin (Week 48). [Baseline and Week 48.]

      The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.

    11. Change From Baseline in Glycosylated Hemoglobin (Week 52). [Baseline and Week 52.]

      The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.

    12. Change From Baseline in Glycosylated Hemoglobin (Final Visit). [Baseline and Final Visit (up to Week 52).]

      The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.

    13. 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 and fasting plasma glucose collected at baseline.

    14. Change From Baseline in Fasting Plasma Glucose (Week 16). [Baseline and Week 16.]

      The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.

    15. Change From Baseline in Fasting Plasma Glucose (Week 20). [Baseline and Week 20.]

      The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.

    16. Change From Baseline in Fasting Plasma Glucose (Week 24). [Baseline and Week 24.]

      The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.

    17. Change From Baseline in Fasting Plasma Glucose (Week 28). [Baseline and Week 28.]

      The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.

    18. Change From Baseline in Fasting Plasma Glucose (Week 32). [Baseline and Week 32.]

      The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.

    19. Change From Baseline in Fasting Plasma Glucose (Week 36). [Baseline and Week 36.]

      The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.

    20. Change From Baseline in Fasting Plasma Glucose (Week 40). [Baseline and Week 40.]

      The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.

    21. Change From Baseline in Fasting Plasma Glucose (Week 44). [Baseline and Week 44.]

      The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.

    22. Change From Baseline in Fasting Plasma Glucose (Week 48). [Baseline and Week 48.]

      The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.

    23. Change From Baseline in Fasting Plasma Glucose (Week 52). [Baseline and Week 52.]

      The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.

    24. Change From Baseline in Fasting Plasma Glucose (Final Visit). [Baseline and Final Visit (up to Week 52).]

      The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.

    25. 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 and fasting C-peptide collected at baseline.

    26. Change From Baseline in Fasting C-peptide (Week 16). [Baseline and Week 16.]

      The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.

    27. Change From Baseline in Fasting C-peptide (Week 20). [Baseline and Week 20.]

      The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.

    28. Change From Baseline in Fasting C-peptide (Week 24). [Baseline and Week 24.]

      The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.

    29. Change From Baseline in Fasting C-peptide (Week 28). [Baseline and Week 28.]

      The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.

    30. Change From Baseline in Fasting C-peptide (Week 32). [Baseline and Week 32.]

      The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.

    31. Change From Baseline in Fasting C-peptide (Week 36). [Baseline and Week 36.]

      The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.

    32. Change From Baseline in Fasting C-peptide (Week 40). [Baseline and Week 40.]

      The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.

    33. Change From Baseline in Fasting C-peptide (Week 44). [Baseline and Week 44.]

      The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.

    34. Change From Baseline in Fasting C-peptide (Week 48). [Baseline and Week 48.]

      The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.

    35. Change From Baseline in Fasting C-peptide (Week 52). [Baseline and Week 52.]

      The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.

    36. Change From Baseline in Fasting C-peptide (Final Visit). [Baseline and Final Visit (up to Week 52).]

      The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.

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

      The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    38. Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24). [Baseline and Week 24.]

      The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    39. Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52). [Baseline and Week 52.]

      The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    40. Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit). [Baseline and Final Visit (up to Week 52).]

      The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

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

      The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    42. Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). [Baseline and Week 24.]

      The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    43. Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). [Baseline and Week 52.]

      The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    44. Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). [Baseline and Final Visit (up to Week 52).]

      The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

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

      The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    46. Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). [Baseline and Week 24.]

      The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    47. Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). [Baseline and Week 52.]

      The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    48. Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). [Baseline and Final Visit (up to Week 52).]

      The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

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

      The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    50. Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). [Baseline and Week 24.]

      The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    51. Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). [Baseline and Week 52.]

      The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    52. Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). [Baseline and Final Visit (up to Week 52).]

      The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

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

      The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    54. Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). [Baseline and Week 24.]

      The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    55. Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). [Baseline and Week 52.]

      The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    56. Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). [Baseline and Final Visit (up to Week 52).]

      The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    29 Years to 87 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).
    Exclusion Criteria:

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

    • Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).

    Contacts and Locations

    Locations

    No locations specified.

    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:
    NCT01263496
    Other Study ID Numbers:
    • SYR-322/OCT-001
    • U1111-1118-4027
    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 53 investigative sites in Japan from 10 May 2007 to 27 September 2008.
    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 5, once-daily (QD) or three-times daily (TID) treatment groups. Analyses were performed by treatment dose group or by treatment dose in this study.
    Arm/Group Title Alogliptin 6.25 mg Dose Group* → Alogliptin 6.25 mg Dose Group Alogliptin 12.5 mg Dose Group* → Alogliptin 12.5 mg Dose Group Alogliptin 25 mg Dose Group* → Alogliptin 25 mg Dose Group Alogliptin 50 mg Dose Group* → Alogliptin 50 mg Dose Group Voglibose 0.2 mg Dose Group* → Voglibose 0.2 mg Dose Group Placebo Dose Group* → Alogliptin 6.25 mg Dose Group Placebo Dose Group* → Alogliptin 12.5 mg Dose Group Placebo Dose Group* → Alogliptin 25 mg Dose Group Placebo Dose Group* → Alogliptin 50 mg Dose Group
    Arm/Group Description Alogliptin 6.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. *for participants from the 6.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study. Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. *for participants from the 12.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study. Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. *for participants from the 25 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study. Alogliptin 50 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. *for participants from the 50 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. *for participants from the voglibose 0.2 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study. Placebo-matching tablets, orally, once or three times daily for up to 40 weeks. *for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study. Placebo-matching tablets, orally, once or three times daily for up to 40 weeks. *for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study. Placebo-matching tablets, orally, once or three times daily for up to 40 weeks. *for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study. Placebo-matching tablets, orally, once or three times daily for up to 40 weeks. *for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
    Period Title: Enrolled - Long-Term Extension Study
    STARTED 72 75 72 75 74 17 17 18 18
    COMPLETED 71 75 72 74 72 17 17 18 18
    NOT COMPLETED 1 0 0 1 2 0 0 0 0
    Period Title: Enrolled - Long-Term Extension Study
    STARTED 71 72 72 74 71 17 17 17 18
    COMPLETED 62 59 62 68 61 16 16 16 15
    NOT COMPLETED 9 13 10 6 10 1 1 1 3

    Baseline Characteristics

    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. Total of all reporting groups
    Overall Participants 96 101 97 97 83 474
    Age, Customized (participants) [Number]
    ≤ 64 years
    69
    71.9%
    67
    66.3%
    64
    66%
    65
    67%
    51
    61.4%
    316
    66.7%
    ≥ 65 years
    27
    28.1%
    34
    33.7%
    33
    34%
    32
    33%
    32
    38.6%
    158
    33.3%
    Sex: Female, Male (Count of Participants)
    Female
    26
    27.1%
    29
    28.7%
    22
    22.7%
    29
    29.9%
    27
    32.5%
    133
    28.1%
    Male
    70
    72.9%
    72
    71.3%
    75
    77.3%
    68
    70.1%
    56
    67.5%
    341
    71.9%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Adverse Events.
    Description A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below.
    Time Frame 52 Weeks.

    Outcome Measure Data

    Analysis Population Description
    Adverse Event Profile in the Safety Analysis Set
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 96 101 97 97 83
    Serious Adverse Event
    1
    1%
    5
    5%
    8
    8.2%
    5
    5.2%
    4
    4.8%
    Serious Adverse Event Related to Study Drug
    1
    1%
    2
    2%
    2
    2.1%
    2
    2.1%
    0
    0%
    Other Adverse Events (Incidence ≥3%)
    78
    81.3%
    81
    80.2%
    81
    83.5%
    88
    90.7%
    74
    89.2%
    2. Secondary 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 and glycosylated hemoglobin collected at baseline.
    Time Frame Baseline and Week 12.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 93 97 94 94 79
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    -0.55
    (0.703)
    -0.70
    (0.545)
    -0.74
    (0.520)
    -0.86
    (0.499)
    -0.15
    (0.735)
    Statistical Analysis 1
    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 -0.401
    Confidence Interval (2-Sided) 95%
    -0.618 to -0.184
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -0.548
    Confidence Interval (2-Sided) 95%
    -0.739 to -0.358
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.590
    Confidence Interval (2-Sided) 95%
    -0.779 to -0.401
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.708
    Confidence Interval (2-Sided) 95%
    -0.894 to -0.522
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Change From Baseline in Glycosylated Hemoglobin (Week 16).
    Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.
    Time Frame Baseline and Week 16.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 88 89 89 91 71
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    -0.57
    (0.758)
    -0.75
    (0.586)
    -0.77
    (0.616)
    -0.90
    (0.565)
    -0.25
    (0.633)
    Statistical Analysis 1
    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 -0.316
    Confidence Interval (2-Sided) 95%
    -0.538 to -0.093
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -0.493
    Confidence Interval (2-Sided) 95%
    -0.684 to -0.302
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.510
    Confidence Interval (2-Sided) 95%
    -0.706 to -0.314
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.647
    Confidence Interval (2-Sided) 95%
    -0.834 to -0.461
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Change From Baseline in Glycosylated Hemoglobin (Week 20).
    Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.
    Time Frame Baseline and Week 20.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 87 87 88 90 69
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    -0.56
    (0.699)
    -0.69
    (0.628)
    -0.70
    (0.672)
    -0.88
    (0.602)
    -0.30
    (0.650)
    Statistical Analysis 1
    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 -0.263
    Confidence Interval (2-Sided) 95%
    -0.479 to -0.047
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -0.395
    Confidence Interval (2-Sided) 95%
    -0.598 to -0.192
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.405
    Confidence Interval (2-Sided) 95%
    -0.616 to -0.195
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.583
    Confidence Interval (2-Sided) 95%
    -0.780 to -0.386
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Change From Baseline in Glycosylated Hemoglobin (Week 24).
    Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.
    Time Frame Baseline and Week 24.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 86 84 89 89 66
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    -0.47
    (0.736)
    -0.61
    (0.697)
    -0.66
    (0.714)
    -0.83
    (0.647)
    -0.29
    (0.730)
    Statistical Analysis 1
    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 -0.172
    Confidence Interval (2-Sided) 95%
    -0.410 to 0.065
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -0.319
    Confidence Interval (2-Sided) 95%
    -0.550 to -0.088
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.370
    Confidence Interval (2-Sided) 95%
    -0.601 to -0.139
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.533
    Confidence Interval (2-Sided) 95%
    -0.752 to -0.314
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Change From Baseline in Glycosylated Hemoglobin (Week 28).
    Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.
    Time Frame Baseline and Week 28.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 85 82 87 86 65
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    -0.39
    (0.804)
    -0.56
    (0.721)
    -0.67
    (0.749)
    -0.78
    (0.705)
    -0.32
    (0.676)
    Statistical Analysis 1
    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 -0.079
    Confidence Interval (2-Sided) 95%
    -0.323 to 0.166
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -0.241
    Confidence Interval (2-Sided) 95%
    -0.471 to -0.011
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.357
    Confidence Interval (2-Sided) 95%
    -0.590 to -0.124
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.467
    Confidence Interval (2-Sided) 95%
    -0.692 to -0.242
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Change From Baseline in Glycosylated Hemoglobin (Week 32).
    Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.
    Time Frame Baseline and Week 32.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 84 81 87 85 64
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    -0.35
    (0.787)
    -0.56
    (0.811)
    -0.61
    (0.777)
    -0.76
    (0.757)
    -0.27
    (0.662)
    Statistical Analysis 1
    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 -0.080
    Confidence Interval (2-Sided) 95%
    -0.321 to 0.162
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -0.294
    Confidence Interval (2-Sided) 95%
    -0.542 to -0.046
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.341
    Confidence Interval (2-Sided) 95%
    -0.579 to -0.103
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.487
    Confidence Interval (2-Sided) 95%
    -0.722 to -0.252
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Change From Baseline in Glycosylated Hemoglobin (Week 36).
    Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.
    Time Frame Baseline and Week 36.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 82 81 82 84 64
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    -0.33
    (0.724)
    -0.52
    (0.857)
    -0.66
    (0.722)
    -0.77
    (0.759)
    -0.28
    (0.664)
    Statistical Analysis 1
    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 -0.049
    Confidence Interval (2-Sided) 95%
    -0.279 to 0.182
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -0.234
    Confidence Interval (2-Sided) 95%
    -0.491 to 0.023
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.375
    Confidence Interval (2-Sided) 95%
    -0.605 to -0.145
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.488
    Confidence Interval (2-Sided) 95%
    -0.724 to -0.252
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Change From Baseline in Glycosylated Hemoglobin (Week 40).
    Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.
    Time Frame Baseline and Week 40.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 81 79 79 84 63
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    -0.33
    (0.686)
    -0.48
    (0.882)
    -0.66
    (0.694)
    -0.77
    (0.765)
    -0.28
    (0.627)
    Statistical Analysis 1
    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 -0.050
    Confidence Interval (2-Sided) 95%
    -0.270 to 0.169
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -0.193
    Confidence Interval (2-Sided) 95%
    -0.453 to 0.067
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.374
    Confidence Interval (2-Sided) 95%
    -0.596 to -0.152
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.490
    Confidence Interval (2-Sided) 95%
    -0.723 to -0.256
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Change From Baseline in Glycosylated Hemoglobin (Week 44).
    Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.
    Time Frame Baseline and Week 44.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 65 61 63 69 63
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    -0.29
    (0.649)
    -0.59
    (0.722)
    -0.71
    (0.767)
    -0.79
    (0.770)
    -0.35
    (0.632)
    Statistical Analysis 1
    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 0.065
    Confidence Interval (2-Sided) 95%
    -0.160 to 0.289
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -0.236
    Confidence Interval (2-Sided) 95%
    -0.477 to 0.005
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.360
    Confidence Interval (2-Sided) 95%
    -0.608 to -0.113
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.435
    Confidence Interval (2-Sided) 95%
    -0.679 to -0.191
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Change From Baseline in Glycosylated Hemoglobin (Week 48).
    Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.
    Time Frame Baseline and Week 48.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 63 60 62 69 61
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    -0.43
    (0.590)
    -0.66
    (0.716)
    -0.76
    (0.736)
    -0.83
    (0.779)
    -0.40
    (0.695)
    Statistical Analysis 1
    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 (Net)
    Estimated Value -0.033
    Confidence Interval (2-Sided) 95%
    -0.262 to 0.196
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -0.262
    Confidence Interval (2-Sided) 95%
    -0.516 to -0.008
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.358
    Confidence Interval (2-Sided) 95%
    -0.614 to -0.103
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.432
    Confidence Interval (2-Sided) 95%
    -0.690 to -0.174
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    12. Secondary Outcome
    Title Change From Baseline in Glycosylated Hemoglobin (Week 52).
    Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.
    Time Frame Baseline and Week 52.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 62 59 62 68 61
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    -0.49
    (0.544)
    -0.65
    (0.726)
    -0.74
    (0.754)
    -0.85
    (0.785)
    -0.37
    (0.723)
    Statistical Analysis 1
    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 -0.118
    Confidence Interval (2-Sided) 95%
    -0.346 to 0.110
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -0.277
    Confidence Interval (2-Sided) 95%
    -0.539 to -0.015
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.373
    Confidence Interval (2-Sided) 95%
    -0.637 to -0.109
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.477
    Confidence Interval (2-Sided) 95%
    -0.741 to -0.213
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title Change From Baseline in Glycosylated Hemoglobin (Final Visit).
    Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.
    Time Frame Baseline and Final Visit (up to Week 52).

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 96 101 96 97 83
    Mean (Standard Deviation) [percentage of Glycosylated Hemoglobin]
    -0.40
    (0.713)
    -0.47
    (0.817)
    -0.63
    (0.788)
    -0.86
    (0.723)
    -0.22
    (0.882)
    Statistical Analysis 1
    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 -0.181
    Confidence Interval (2-Sided) 95%
    -0.416 to 0.055
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -0.245
    Confidence Interval (2-Sided) 95%
    -0.492 to 0.003
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.408
    Confidence Interval (2-Sided) 95%
    -0.654 to -0.161
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.638
    Confidence Interval (2-Sided) 95%
    -0.874 to -0.402
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. 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 and fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 12

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 93 97 94 94 79
    Mean (Standard Deviation) [mg/dL]
    -12.1
    (32.26)
    -15.3
    (23.57)
    -17.0
    (21.42)
    -23.0
    (23.35)
    -3.6
    (26.98)
    Statistical Analysis 1
    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 -8.51
    Confidence Interval (2-Sided) 95%
    -17.56 to 0.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -11.70
    Confidence Interval (2-Sided) 95%
    -19.23 to -4.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -13.41
    Confidence Interval (2-Sided) 95%
    -20.68 to -6.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -19.38
    Confidence Interval (2-Sided) 95%
    -26.93 to -11.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (Week 16).
    Description The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 16.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 88 89 89 97 71
    Mean (Standard Deviation) [mg/dL]
    -10.8
    (24.52)
    -15.8
    (23.76)
    -17.0
    (23.34)
    -18.8
    (29.74)
    -6.4
    (28.02)
    Statistical Analysis 1
    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 -4.44
    Confidence Interval (2-Sided) 95%
    -12.67 to 3.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -9.39
    Confidence Interval (2-Sided) 95%
    -17.48 to -1.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -10.56
    Confidence Interval (2-Sided) 95%
    -18.58 to -2.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -12.37
    Confidence Interval (2-Sided) 95%
    -21.44 to -3.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (Week 20).
    Description The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 20.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 87 87 88 90 69
    Mean (Standard Deviation) [mg/dL]
    -11.5
    (27.50)
    -15.3
    (24.49)
    -13.8
    (23.10)
    -20.1
    (27.94)
    -4.6
    (27.53)
    Statistical Analysis 1
    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 -6.90
    Confidence Interval (2-Sided) 95%
    -15.66 to 1.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -10.73
    Confidence Interval (2-Sided) 95%
    -18.97 to -2.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -9.21
    Confidence Interval (2-Sided) 95%
    -17.20 to -1.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -15.49
    Confidence Interval (2-Sided) 95%
    -24.27 to -6.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    17. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (Week 24).
    Description The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 24.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 86 84 89 89 66
    Mean (Standard Deviation) [mg/dL]
    -10.6
    (29.15)
    -11.7
    (28.19)
    -13.8
    (23.70)
    -20.2
    (28.90)
    -8.3
    (25.58)
    Statistical Analysis 1
    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 -2.27
    Confidence Interval (2-Sided) 95%
    -11.22 to 6.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -3.36
    Confidence Interval (2-Sided) 95%
    -12.16 to 5.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -5.43
    Confidence Interval (2-Sided) 95%
    -13.30 to 2.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -11.90
    Confidence Interval (2-Sided) 95%
    -20.74 to -3.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    18. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (Week 28).
    Description The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 28.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 85 82 87 86 65
    Mean (Standard Deviation) [mg/dL]
    -9.6
    (30.07)
    -13.4
    (30.06)
    -14.1
    (23.86)
    -19.9
    (32.36)
    -7.2
    (28.13)
    Statistical Analysis 1
    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 -2.44
    Confidence Interval (2-Sided) 95%
    -11.97 to 7.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -6.25
    Confidence Interval (2-Sided) 95%
    -15.84 to 3.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -6.93
    Confidence Interval (2-Sided) 95%
    -15.28 to 1.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -12.73
    Confidence Interval (2-Sided) 95%
    -22.67 to -2.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    19. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (Week 32).
    Description The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 32.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 84 81 87 85 64
    Mean (Standard Deviation) [mg/dL]
    -14.5
    (21.13)
    -12.9
    (31.64)
    -14.9
    (25.86)
    -20.3
    (30.72)
    -9.1
    (26.59)
    Statistical Analysis 1
    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 -5.44
    Confidence Interval (2-Sided) 95%
    -13.19 to 2.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -3.77
    Confidence Interval (2-Sided) 95%
    -13.53 to 5.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -5.85
    Confidence Interval (2-Sided) 95%
    -14.36 to 2.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -11.22
    Confidence Interval (2-Sided) 95%
    -20.72 to -1.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    20. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (Week 36).
    Description The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 36.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 81 82 81 84 64
    Mean (Standard Deviation) [mg/dL]
    -10.7
    (24.25)
    -14.3
    (32.31)
    -16.9
    (23.66)
    -20.9
    (32.48)
    -8.4
    (25.36)
    Statistical Analysis 1
    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 -2.26
    Confidence Interval (2-Sided) 95%
    -10.42 to 5.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -5.90
    Confidence Interval (2-Sided) 95%
    -15.64 to 3.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -8.47
    Confidence Interval (2-Sided) 95%
    -16.52 to -0.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -12.47
    Confidence Interval (2-Sided) 95%
    -22.18 to -2.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    21. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (Week 40).
    Description The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 40.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 81 79 79 84 63
    Mean (Standard Deviation) [mg/dL]
    -13.5
    (19.32)
    -14.8
    (28.76)
    -15.7
    (21.38)
    -23.2
    (29.40)
    -13.8
    (25.82)
    Statistical Analysis 1
    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 0.34
    Confidence Interval (2-Sided) 95%
    -7.10 to 7.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -0.98
    Confidence Interval (2-Sided) 95%
    -10.16 to 8.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -1.88
    Confidence Interval (2-Sided) 95%
    -9.71 to 5.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -9.38
    Confidence Interval (2-Sided) 95%
    -18.59 to -0.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    22. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (Week 44).
    Description The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 44.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 65 61 63 69 63
    Mean (Standard Deviation) [mg/dL]
    -16.7
    (22.28)
    -18.7
    (26.79)
    -19.0
    (24.77)
    -24.7
    (29.69)
    -15.0
    (26.09)
    Statistical Analysis 1
    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 -1.72
    Confidence Interval (2-Sided) 95%
    -10.20 to 6.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -3.70
    Confidence Interval (2-Sided) 95%
    -13.10 to 5.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -3.97
    Confidence Interval (2-Sided) 95%
    -12.94 to 5.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -9.74
    Confidence Interval (2-Sided) 95%
    -19.40 to -0.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    23. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (Week 48).
    Description The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 48.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 62 60 62 69 61
    Mean (Standard Deviation) [mg/dL]
    -16.0
    (21.54)
    -20.8
    (24.97)
    -22.8
    (21.89)
    -25.4
    (30.50)
    -13.5
    (26.30)
    Statistical Analysis 1
    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 -2.43
    Confidence Interval (2-Sided) 95%
    -11.00 to 6.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -7.29
    Confidence Interval (2-Sided) 95%
    -16.53 to 1.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -9.30
    Confidence Interval (2-Sided) 95%
    -17.93 to -0.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -11.88
    Confidence Interval (2-Sided) 95%
    -21.83 to -1.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    24. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (Week 52).
    Description The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.
    Time Frame Baseline and Week 52.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 62 59 62 68 61
    Mean (Standard Deviation) [mg/dL]
    -13.7
    (21.54)
    -19.5
    (25.63)
    -21.4
    (22.35)
    -26.0
    (29.05)
    -12.5
    (25.77)
    Statistical Analysis 1
    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 -1.20
    Confidence Interval (2-Sided) 95%
    -9.68 to 7.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -7.05
    Confidence Interval (2-Sided) 95%
    -16.34 to 2.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -8.86
    Confidence Interval (2-Sided) 95%
    -17.47 to -0.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -13.51
    Confidence Interval (2-Sided) 95%
    -23.12 to -3.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    25. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (Final Visit).
    Description The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.
    Time Frame Baseline and Final Visit (up to Week 52).

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 96 101 96 97 83
    Mean (Standard Deviation) [mg/dL]
    -10.4
    (27.13)
    -15.5
    (31.02)
    -17.1
    (26.50)
    -27.6
    (28.13)
    -8.8
    (30.14)
    Statistical Analysis 1
    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 -1.65
    Confidence Interval (2-Sided) 95%
    -10.09 to 6.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -6.70
    Confidence Interval (2-Sided) 95%
    -15.66 to 2.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -8.28
    Confidence Interval (2-Sided) 95%
    -16.64 to 0.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -18.82
    Confidence Interval (2-Sided) 95%
    -27.39 to -10.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    26. 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 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 12.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 93 97 94 94 79
    Mean (Standard Deviation) [ng/mL]
    -0.02
    (0.667)
    0.19
    (0.604)
    0.19
    (0.567)
    0.25
    (0.706)
    -0.04
    (0.900)
    Statistical Analysis 1
    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 0.017
    Confidence Interval (2-Sided) 95%
    -0.219 to 0.254
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 0.226
    Confidence Interval (2-Sided) 95%
    0.002 to 0.451
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 0.230
    Confidence Interval (2-Sided) 95%
    0.008 to 0.453
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 0.282
    Confidence Interval (2-Sided) 95%
    0.041 to 0.524
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    27. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 16).
    Description The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 16.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 88 89 89 91 71
    Mean (Standard Deviation) [ng/mL]
    0.08
    (0.790)
    0.22
    (0.640)
    0.33
    (0.679)
    0.46
    (0.924)
    -0.01
    (0.886)
    Statistical Analysis 1
    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 0.090
    Confidence Interval (2-Sided) 95%
    -0.173 to 0.353
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 0.228
    Confidence Interval (2-Sided) 95%
    -0.010 to 0.467
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 0.339
    Confidence Interval (2-Sided) 95%
    0.095 to 0.584
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 0.468
    Confidence Interval (2-Sided) 95%
    0.184 to 0.752
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    28. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 20).
    Description The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 20.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 86 86 88 90 69
    Mean (Standard Deviation) [ng/mL]
    0.15
    (0.634)
    0.35
    (0.781)
    0.28
    (0.608)
    0.56
    (0.971)
    -0.16
    (0.953)
    Statistical Analysis 1
    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 0.317
    Confidence Interval (2-Sided) 95%
    0.064 to 0.570
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 0.511
    Confidence Interval (2-Sided) 95%
    0.236 to 0.786
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 0.437
    Confidence Interval (2-Sided) 95%
    0.190 to 0.685
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 0.718
    Confidence Interval (2-Sided) 95%
    0.413 to 1.022
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    29. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 24).
    Description The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 24.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 83 80 83 85 66
    Mean (Standard Deviation) [ng/mL]
    0.12
    (0.742)
    0.26
    (0.722)
    0.20
    (0.603)
    0.23
    (0.620)
    -0.10
    (0.831)
    Statistical Analysis 1
    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 0.226
    Confidence Interval (2-Sided) 95%
    -0.029 to 0.481
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 0.358
    Confidence Interval (2-Sided) 95%
    0.104 to 0.612
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 0.308
    Confidence Interval (2-Sided) 95%
    0.076 to 0.540
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 0.331
    Confidence Interval (2-Sided) 95%
    0.098 to 0.565
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    30. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 28).
    Description The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 28.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 80 73 77 80 65
    Mean (Standard Deviation) [ng/mL]
    0.11
    (0.692)
    0.21
    (0.642)
    0.26
    (0.591)
    0.29
    (0.857)
    -0.04
    (0.951)
    Statistical Analysis 1
    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 0.140
    Confidence Interval (2-Sided) 95%
    -0.130 to 0.410
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 0.245
    Confidence Interval (2-Sided) 95%
    -0.026 to 0.516
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 0.294
    Confidence Interval (2-Sided) 95%
    0.035 to 0.552
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 0.329
    Confidence Interval (2-Sided) 95%
    0.032 to 0.626
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    31. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 32).
    Description The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 32.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 67 66 74 73 63
    Mean (Standard Deviation) [ng/mL]
    0.03
    (0.778)
    0.41
    (0.652)
    0.45
    (0.718)
    0.37
    (0.816)
    -0.01
    (0.950)
    Statistical Analysis 1
    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 0.049
    Confidence Interval (2-Sided) 95%
    -0.252 to 0.349
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 0.420
    Confidence Interval (2-Sided) 95%
    0.138 to 0.703
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 0.460
    Confidence Interval (2-Sided) 95%
    0.178 to 0.742
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 0.384
    Confidence Interval (2-Sided) 95%
    0.085 to 0.683
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    32. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 36).
    Description The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 36.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 55 46 50 54 48
    Mean (Standard Deviation) [ng/mL]
    0.12
    (0.714)
    0.33
    (0.639)
    0.20
    (0.750)
    0.42
    (0.856)
    0.09
    (0.777)
    Statistical Analysis 1
    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 0.035
    Confidence Interval (2-Sided) 95%
    -0.257 to 0.326
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 0.249
    Confidence Interval (2-Sided) 95%
    -0.043 to 0.542
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 0.111
    Confidence Interval (2-Sided) 95%
    -0.196 to 0.417
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 0.333
    Confidence Interval (2-Sided) 95%
    0.010 to 0.656
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    33. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 40).
    Description The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 40.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 33 26 35 41 35
    Mean (Standard Deviation) [ng/mL]
    -0.14
    (0.998)
    0.48
    (0.836)
    0.27
    (0.735)
    0.44
    (0.567)
    0.13
    (1.066)
    Statistical Analysis 1
    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 -0.268
    Confidence Interval (2-Sided) 95%
    -0.769 to 0.233
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 0.349
    Confidence Interval (2-Sided) 95%
    -0.156 to 0.855
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 0.140
    Confidence Interval (2-Sided) 95%
    -0.297 to 0.577
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 0.308
    Confidence Interval (2-Sided) 95%
    -0.075 to 0.690
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    34. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 44).
    Description The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 44.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 17 18 20 20 21
    Mean (Standard Deviation) [ng/mL]
    0.22
    (0.963)
    0.52
    (0.887)
    0.59
    (0.881)
    0.20
    (0.651)
    -0.06
    (0.991)
    Statistical Analysis 1
    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 0.281
    Confidence Interval (2-Sided) 95%
    -0.367 to 0.928
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 0.579
    Confidence Interval (2-Sided) 95%
    -0.035 to 1.194
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 0.647
    Confidence Interval (2-Sided) 95%
    0.054 to 1.241
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 0.252
    Confidence Interval (2-Sided) 95%
    -0.280 to 0.785
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    35. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 48).
    Description The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 48.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 6 7 9 6 9
    Mean (Standard Deviation) [ng/mL]
    -0.40
    (0.632)
    0.54
    (0.796)
    0.04
    (0.485)
    0.15
    (0.558)
    -0.10
    (0.934)
    Statistical Analysis 1
    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 -0.300
    Confidence Interval (2-Sided) 95%
    -1.246 to 0.646
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 0.643
    Confidence Interval (2-Sided) 95%
    -0.305 to 1.591
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 0.144
    Confidence Interval (2-Sided) 95%
    -0.599 to 0.888
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 0.250
    Confidence Interval (2-Sided) 95%
    -0.673 to 1.173
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    36. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Week 52).
    Description The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.
    Time Frame Baseline and Week 52.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 2 3 3 4 3
    Mean (Standard Deviation) [ng/mL]
    -0.25
    (0.212)
    0.73
    (0.874)
    0.10
    (0.781)
    0.30
    (1.095)
    0.70
    (1.473)
    Statistical Analysis 1
    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 -0.950
    Confidence Interval (2-Sided) 95%
    -4.462 to 2.562
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 0.033
    Confidence Interval (2-Sided) 95%
    -2.712 to 2.779
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.600
    Confidence Interval (2-Sided) 95%
    -3.273 to 2.073
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.400
    Confidence Interval (2-Sided) 95%
    -2.874 to 2.074
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    37. Secondary Outcome
    Title Change From Baseline in Fasting C-peptide (Final Visit).
    Description The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.
    Time Frame Baseline and Final Visit (up to Week 52).

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 96 101 96 97 83
    Mean (Standard Deviation) [ng/mL]
    0.34
    (1.046)
    0.44
    (0.820)
    0.32
    (0.805)
    0.48
    (0.765)
    0.18
    (0.970)
    Statistical Analysis 1
    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 0.159
    Confidence Interval (2-Sided) 95%
    -0.140 to 0.458
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 0.260
    Confidence Interval (2-Sided) 95%
    -0.001 to 0.520
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 0.136
    Confidence Interval (2-Sided) 95%
    -0.126 to 0.398
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 0.298
    Confidence Interval (2-Sided) 95%
    0.042 to 0.553
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    38. Secondary Outcome
    Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).
    Description The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 12.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 93 97 95 94 79
    Mean (Standard Deviation) [mg/dL]
    62.9
    (33.75)
    61.8
    (31.41)
    56.4
    (36.70)
    55.8
    (30.83)
    64.8
    (31.62)
    Statistical Analysis 1
    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 -1.92
    Confidence Interval (2-Sided) 95%
    -11.82 to 7.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -3.02
    Confidence Interval (2-Sided) 95%
    -12.45 to 6.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -8.41
    Confidence Interval (2-Sided) 95%
    -18.77 to 1.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -8.96
    Confidence Interval (2-Sided) 95%
    -18.35 to 0.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    39. Secondary Outcome
    Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).
    Description The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 24.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 71 68 74 74 67
    Mean (Standard Deviation) [mg/dL]
    64.3
    (37.80)
    55.5
    (30.63)
    55.5
    (39.78)
    55.9
    (33.60)
    56.6
    (30.02)
    Statistical Analysis 1
    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 7.66
    Confidence Interval (2-Sided) 95%
    -3.88 to 19.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -1.08
    Confidence Interval (2-Sided) 95%
    -11.41 to 9.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -1.08
    Confidence Interval (2-Sided) 95%
    -12.91 to 10.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.66
    Confidence Interval (2-Sided) 95%
    -11.32 to 9.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    40. Secondary Outcome
    Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).
    Description The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 52.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 80 76 78 83 61
    Mean (Standard Deviation) [mg/dL]
    65.7
    (38.39)
    62.6
    (30.18)
    58.3
    (32.62)
    51.8
    (36.73)
    61.0
    (30.16)
    Statistical Analysis 1
    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 4.70
    Confidence Interval (2-Sided) 95%
    -7.09 to 16.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 1.63
    Confidence Interval (2-Sided) 95%
    -8.63 to 11.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -2.69
    Confidence Interval (2-Sided) 95%
    -13.36 to 7.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -9.20
    Confidence Interval (2-Sided) 95%
    -20.58 to 2.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    41. Secondary Outcome
    Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).
    Description The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Final Visit (up to Week 52).

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 93 97 95 94 79
    Mean (Standard Deviation) [mg/dL]
    65.0
    (37.48)
    63.8
    (32.46)
    60.4
    (35.09)
    52.6
    (37.07)
    52.6
    (32.38)
    Statistical Analysis 1
    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 -0.80
    Confidence Interval (2-Sided) 95%
    -11.44 to 9.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -2.04
    Confidence Interval (2-Sided) 95%
    -11.74 to 7.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -5.44
    Confidence Interval (2-Sided) 95%
    -15.62 to 4.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -13.28
    Confidence Interval (2-Sided) 95%
    -23.83 to -2.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    42. Secondary Outcome
    Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
    Description The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 12.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 93 97 95 94 79
    Mean (Standard Deviation) [mg·hr/dL]
    -57.0
    (75.68)
    -55.4
    (61.17)
    -67.8
    (55.52)
    -80.5
    (51.95)
    -50.0
    (62.49)
    Statistical Analysis 1
    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 -7.02
    Confidence Interval (2-Sided) 95%
    -28.15 to 14.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 -5.45
    Confidence Interval (2-Sided) 95%
    -23.93 to 13.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -17.80
    Confidence Interval (2-Sided) 95%
    -35.46 to -0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -30.58
    Confidence Interval (2-Sided) 95%
    -47.75 to -13.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    43. Secondary Outcome
    Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
    Description The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 24.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 70 68 74 74 67
    Mean (Standard Deviation) [mg·hr/dL]
    -43.9
    (76.23)
    -52.5
    (74.32)
    -69.8
    (73.23)
    -75.1
    (68.57)
    -62.4
    (62.68)
    Statistical Analysis 1
    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 18.45
    Confidence Interval (2-Sided) 95%
    -5.18 to 42.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 9.86
    Confidence Interval (2-Sided) 95%
    -13.56 to 33.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -7.44
    Confidence Interval (2-Sided) 95%
    -30.25 to 15.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -12.80
    Confidence Interval (2-Sided) 95%
    -34.75 to 9.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    44. Secondary Outcome
    Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
    Description The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 52.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 80 76 78 83 61
    Mean (Standard Deviation) [mg·hr/dL]
    -59.5
    (50.66)
    -62.0
    (59.52)
    -69.0
    (64.88)
    -88.7
    (73.36)
    -65.4
    (67.93)
    Statistical Analysis 1
    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 5.84
    Confidence Interval (2-Sided) 95%
    -13.90 to 25.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 3.35
    Confidence Interval (2-Sided) 95%
    -18.20 to 24.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -3.64
    Confidence Interval (2-Sided) 95%
    -26.03 to 18.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -23.37
    Confidence Interval (2-Sided) 95%
    -47.08 to 0.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    45. Secondary Outcome
    Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
    Description The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Final Visit (up to Week 52).

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 93 97 95 94 79
    Mean (Standard Deviation) [mg·hr/dL]
    -53.5
    (70.32)
    -55.1
    (76.72)
    -67.6
    (69.49)
    -91.3
    (71.93)
    -56.4
    (73.88)
    Statistical Analysis 1
    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 2.97
    Confidence Interval (2-Sided) 95%
    -18.77 to 24.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 1.37
    Confidence Interval (2-Sided) 95%
    -21.21 to 23.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -11.20
    Confidence Interval (2-Sided) 95%
    -32.69 to 10.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -34.90
    Confidence Interval (2-Sided) 95%
    -56.85 to -12.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    46. Secondary Outcome
    Title Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
    Description The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 12.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 93 97 95 94 79
    Mean (Standard Deviation) [ng·hr/mL]
    0.56
    (1.765)
    0.97
    (1.975)
    0.96
    (2.073)
    0.99
    (1.742)
    -0.39
    (2.091)
    Statistical Analysis 1
    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 0.955
    Confidence Interval (2-Sided) 95%
    0.375 to 1.535
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 1.358
    Confidence Interval (2-Sided) 95%
    0.752 to 1.965
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 1.350
    Confidence Interval (2-Sided) 95%
    0.724 to 1.975
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 1.380
    Confidence Interval (2-Sided) 95%
    0.804 to 1.955
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    47. Secondary Outcome
    Title Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
    Description The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 24.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 69 68 72 74 67
    Mean (Standard Deviation) [ng·hr/mL]
    0.93
    (2.068)
    1.35
    (1.928)
    1.14
    (1.743)
    1.38
    (1.934)
    -0.10
    (1.994)
    Statistical Analysis 1
    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 1.034
    Confidence Interval (2-Sided) 95%
    0.344 to 1.723
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 1.448
    Confidence Interval (2-Sided) 95%
    0.780 to 2.115
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 1.243
    Confidence Interval (2-Sided) 95%
    0.616 to 1.870
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 1.481
    Confidence Interval (2-Sided) 95%
    0.827 to 2.136
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    48. Secondary Outcome
    Title Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
    Description The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 52.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 6 4 3 5 3
    Mean (Standard Deviation) [ng·hr/mL]
    1.91
    (2.922)
    3.44
    (3.320)
    2.37
    (5.399)
    3.14
    (2.368)
    1.86
    (0.293)
    Statistical Analysis 1
    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 0.050
    Confidence Interval (2-Sided) 95%
    -4.088 to 4.188
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 1.585
    Confidence Interval (2-Sided) 95%
    -3.476 to 6.647
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 0.517
    Confidence Interval (2-Sided) 95%
    -8.151 to 9.184
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 1.277
    Confidence Interval (2-Sided) 95%
    -2.191 to 4.744
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    49. Secondary Outcome
    Title Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
    Description The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Final Visit (up to Week 52).

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 92 97 95 94 79
    Mean (Standard Deviation) [ng·hr/mL]
    0.99
    (2.087)
    1.45
    (2.257)
    1.14
    (2.054)
    1.41
    (2.028)
    0.15
    (1.866)
    Statistical Analysis 1
    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 0.841
    Confidence Interval (2-Sided) 95%
    0.239 to 1.443
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 1.304
    Confidence Interval (2-Sided) 95%
    0.679 to 1.930
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 0.992
    Confidence Interval (2-Sided) 95%
    0.400 to 1.585
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 1.263
    Confidence Interval (2-Sided) 95%
    0.674 to 1.853
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    50. Secondary Outcome
    Title Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
    Description The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 12

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 86 94 85 90 68
    Mean (Standard Deviation) [μU·hr/mL]
    0.49
    (18.988)
    2.63
    (15.416)
    4.44
    (13.637)
    -0.03
    (21.572)
    -15.40
    (20.416)
    Statistical Analysis 1
    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 15.891
    Confidence Interval (2-Sided) 95%
    9.597 to 22.184
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 18.026
    Confidence Interval (2-Sided) 95%
    12.466 to 23.585
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 19.838
    Confidence Interval (2-Sided) 95%
    14.379 to 25.297
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 15.368
    Confidence Interval (2-Sided) 95%
    8.677 to 22.060
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    51. Secondary Outcome
    Title Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
    Description The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 24.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 61 64 68 71 59
    Mean (Standard Deviation) [μU·hr/mL]
    -1.89
    (21.943)
    4.50
    (12.876)
    2.85
    (12.309)
    -0.98
    (27.457)
    -16.21
    (20.927)
    Statistical Analysis 1
    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 14.323
    Confidence Interval (2-Sided) 95%
    6.567 to 22.079
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 20.714
    Confidence Interval (2-Sided) 95%
    14.563 to 26.864
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 19.063
    Confidence Interval (2-Sided) 95%
    13.125 to 25.002
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 15.233
    Confidence Interval (2-Sided) 95%
    6.618 to 23.847
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    52. Secondary Outcome
    Title Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
    Description The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 52.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 76 70 75 80 56
    Mean (Standard Deviation) [μU·hr/mL]
    -7.62
    (19.526)
    -1.71
    (15.032)
    -0.44
    (14.871)
    -2.30
    (22.985)
    -15.66
    (20.026)
    Statistical Analysis 1
    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 8.047
    Confidence Interval (2-Sided) 95%
    1.169 to 14.924
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 13.950
    Confidence Interval (2-Sided) 95%
    7.767 to 20.133
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 15.221
    Confidence Interval (2-Sided) 95%
    9.191 to 21.251
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 13.366
    Confidence Interval (2-Sided) 95%
    5.847 to 20.885
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    53. Secondary Outcome
    Title Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
    Description The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Final Visit (up to Week 52).

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 87 91 91 91 70
    Mean (Standard Deviation) [μU·hr/mL]
    -6.93
    (18.945)
    -1.67
    (15.508)
    0.43
    (14.532)
    -1.56
    (21.843)
    -14.65
    (19.322)
    Statistical Analysis 1
    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 7.719
    Confidence Interval (2-Sided) 95%
    1.657 to 13.782
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 12.978
    Confidence Interval (2-Sided) 95%
    7.556 to 18.399
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 15.076
    Confidence Interval (2-Sided) 95%
    9.808 to 20.345
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 13.087
    Confidence Interval (2-Sided) 95%
    6.561 to 19.614
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    54. Secondary Outcome
    Title Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
    Description The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 12

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 92 96 95 93 79
    Mean (Standard Deviation) [pg·hr/mL]
    -9.5
    (38.86)
    -4.4
    (36.89)
    -6.6
    (46.85)
    -15.5
    (41.23)
    -16.3
    (52.26)
    Statistical Analysis 1
    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 6.76
    Confidence Interval (2-Sided) 95%
    -7.03 to 20.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 11.85
    Confidence Interval (2-Sided) 95%
    -1.49 to 25.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 9.72
    Confidence Interval (2-Sided) 95%
    -5.12 to 24.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 0.82
    Confidence Interval (2-Sided) 95%
    -13.26 to 14.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    55. Secondary Outcome
    Title Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
    Description The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 24.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 70 67 74 74 67
    Mean (Standard Deviation) [pg·hr/mL]
    -1.7
    (37.90)
    3.0
    (41.66)
    0.9
    (50.56)
    -0.8
    (43.71)
    -7.6
    (60.64)
    Statistical Analysis 1
    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 5.90
    Confidence Interval (2-Sided) 95%
    -11.11 to 22.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 10.57
    Confidence Interval (2-Sided) 95%
    -7.21 to 28.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 8.45
    Confidence Interval (2-Sided) 95%
    -10.08 to 26.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 6.82
    Confidence Interval (2-Sided) 95%
    -10.67 to 24.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    56. Secondary Outcome
    Title Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
    Description The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Week 52.

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 80 75 78 82 61
    Mean (Standard Deviation) [pg·hr/mL]
    -10.7
    (47.21)
    -11.3
    (45.41)
    -14.5
    (59.39)
    -12.5
    (52.10)
    -13.8
    (61.15)
    Statistical Analysis 1
    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 3.09
    Confidence Interval (2-Sided) 95%
    -14.95 to 21.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 2.48
    Confidence Interval (2-Sided) 95%
    -15.61 to 20.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 -0.66
    Confidence Interval (2-Sided) 95%
    -21.00 to 19.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 1.29
    Confidence Interval (2-Sided) 95%
    -17.47 to 20.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    57. Secondary Outcome
    Title Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
    Description The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
    Time Frame Baseline and Final Visit (up to Week 52).

    Outcome Measure Data

    Analysis Population Description
    Values are Summary Statistics.
    Arm/Group Title 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    Measure Participants 93 96 95 93 79
    Mean (Standard Deviation) [pg·hr/mL]
    -9.8
    (45.93)
    -9.0
    (48.99)
    -10.3
    (61.18)
    -14.6
    (51.22)
    -13.9
    (58.84)
    Statistical Analysis 1
    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 4.08
    Confidence Interval (2-Sided) 95%
    -11.70 to 19.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    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 4.94
    Confidence Interval (2-Sided) 95%
    -11.14 to 21.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    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 3.65
    Confidence Interval (2-Sided) 95%
    -14.42 to 21.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    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 -0.68
    Confidence Interval (2-Sided) 95%
    -17.24 to 15.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of 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 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 Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
    All Cause Mortality
    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
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    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
    Total 2/96 (2.1%) 8/101 (7.9%) 8/97 (8.2%) 5/97 (5.2%) 4/83 (4.8%)
    Cardiac disorders
    Atrial fibrillation 0/96 (0%) 0/101 (0%) 1/97 (1%) 0/97 (0%) 0/83 (0%)
    Myocardial infarction 0/96 (0%) 0/101 (0%) 1/97 (1%) 0/97 (0%) 0/83 (0%)
    Gastrointestinal disorders
    Crohn's disease 0/96 (0%) 0/101 (0%) 1/97 (1%) 0/97 (0%) 0/83 (0%)
    Gastric ulcer haemorrhage 0/96 (0%) 1/101 (1%) 0/97 (0%) 0/97 (0%) 0/83 (0%)
    Inguinal hernia 0/96 (0%) 1/101 (1%) 0/97 (0%) 0/97 (0%) 0/83 (0%)
    Pancreatitis acute 0/96 (0%) 0/101 (0%) 1/97 (1%) 0/97 (0%) 0/83 (0%)
    Hepatobiliary disorders
    Cholelithiasis 0/96 (0%) 1/101 (1%) 0/97 (0%) 0/97 (0%) 0/83 (0%)
    Immune system disorders
    Drug hypersensitivity 0/96 (0%) 1/101 (1%) 0/97 (0%) 0/97 (0%) 0/83 (0%)
    Infections and infestations
    Pneumonia 0/96 (0%) 0/101 (0%) 1/97 (1%) 0/97 (0%) 2/83 (2.4%)
    Cellulitis 0/96 (0%) 0/101 (0%) 0/97 (0%) 0/97 (0%) 1/83 (1.2%)
    Gastroenteritis 0/96 (0%) 0/101 (0%) 0/97 (0%) 1/97 (1%) 0/83 (0%)
    Injury, poisoning and procedural complications
    Accident 0/96 (0%) 0/101 (0%) 0/97 (0%) 0/97 (0%) 1/83 (1.2%)
    Metabolism and nutrition disorders
    Hypoglycaemia 0/96 (0%) 1/101 (1%) 0/97 (0%) 0/97 (0%) 0/83 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer 0/96 (0%) 0/101 (0%) 0/97 (0%) 1/97 (1%) 0/83 (0%)
    Colon cancer 0/96 (0%) 1/101 (1%) 0/97 (0%) 0/97 (0%) 0/83 (0%)
    Gastric cancer 0/96 (0%) 1/101 (1%) 0/97 (0%) 0/97 (0%) 0/83 (0%)
    Meningioma 1/96 (1%) 0/101 (0%) 0/97 (0%) 0/97 (0%) 0/83 (0%)
    Pancreatic carcinoma 0/96 (0%) 0/101 (0%) 1/97 (1%) 0/97 (0%) 0/83 (0%)
    Papillary thyroid cancer 0/96 (0%) 0/101 (0%) 0/97 (0%) 1/97 (1%) 0/83 (0%)
    Hepatic cancer metastatic 0/96 (0%) 1/101 (1%) 0/97 (0%) 0/97 (0%) 0/83 (0%)
    Breast cancer female 0/96 (0%) 0/101 (0%) 0/97 (0%) 0/97 (0%) 1/83 (1.2%)
    Large intestine carcinoma 0/96 (0%) 0/101 (0%) 0/97 (0%) 1/97 (1%) 0/83 (0%)
    Nervous system disorders
    Cerebral infarction 1/96 (1%) 0/101 (0%) 1/97 (1%) 1/97 (1%) 0/83 (0%)
    Vascular disorders
    Hypertension 0/96 (0%) 0/101 (0%) 1/97 (1%) 0/97 (0%) 0/83 (0%)
    Other (Not Including Serious) Adverse Events
    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
    Total 78/96 (81.3%) 81/101 (80.2%) 81/97 (83.5%) 88/97 (90.7%) 74/83 (89.2%)
    Ear and labyrinth disorders
    Tinnitus 0/96 (0%) 0/101 (0%) 0/97 (0%) 1/97 (1%) 3/83 (3.6%)
    Eye disorders
    Cataract 5/96 (5.2%) 2/101 (2%) 2/97 (2.1%) 2/97 (2.1%) 2/83 (2.4%)
    Diabetic retinopathy 3/96 (3.1%) 2/101 (2%) 1/97 (1%) 2/97 (2.1%) 1/83 (1.2%)
    Conjunctivitis allergic 3/96 (3.1%) 0/101 (0%) 0/97 (0%) 2/97 (2.1%) 2/83 (2.4%)
    Gastrointestinal disorders
    Constipation 3/96 (3.1%) 3/101 (3%) 4/97 (4.1%) 6/97 (6.2%) 8/83 (9.6%)
    Dental caries 4/96 (4.2%) 4/101 (4%) 2/97 (2.1%) 6/97 (6.2%) 5/83 (6%)
    Flatulence 2/96 (2.1%) 4/101 (4%) 1/97 (1%) 2/97 (2.1%) 8/83 (9.6%)
    Abdominal distension 2/96 (2.1%) 2/101 (2%) 4/97 (4.1%) 2/97 (2.1%) 6/83 (7.2%)
    Abdominal pain upper 3/96 (3.1%) 2/101 (2%) 3/97 (3.1%) 5/97 (5.2%) 2/83 (2.4%)
    Gastritis 2/96 (2.1%) 3/101 (3%) 1/97 (1%) 4/97 (4.1%) 3/83 (3.6%)
    Diarrhoea 2/96 (2.1%) 1/101 (1%) 2/97 (2.1%) 3/97 (3.1%) 4/83 (4.8%)
    Periodontal disease 2/96 (2.1%) 2/101 (2%) 1/97 (1%) 3/97 (3.1%) 1/83 (1.2%)
    General disorders
    Malaise 0/96 (0%) 1/101 (1%) 4/97 (4.1%) 0/97 (0%) 1/83 (1.2%)
    Hepatobiliary disorders
    Gallbladder polyp 1/96 (1%) 0/101 (0%) 0/97 (0%) 2/97 (2.1%) 3/83 (3.6%)
    Immune system disorders
    Seasonal allergy 7/96 (7.3%) 5/101 (5%) 3/97 (3.1%) 1/97 (1%) 2/83 (2.4%)
    Infections and infestations
    Nasopharyngitis 29/96 (30.2%) 29/101 (28.7%) 32/97 (33%) 34/97 (35.1%) 21/83 (25.3%)
    Bronchitis 4/96 (4.2%) 6/101 (5.9%) 1/97 (1%) 4/97 (4.1%) 1/83 (1.2%)
    Gastroenteritis 2/96 (2.1%) 2/101 (2%) 4/97 (4.1%) 3/97 (3.1%) 3/83 (3.6%)
    Pharyngitis 0/96 (0%) 2/101 (2%) 2/97 (2.1%) 2/97 (2.1%) 3/83 (3.6%)
    Tinea pedis 2/96 (2.1%) 1/101 (1%) 0/97 (0%) 2/97 (2.1%) 3/83 (3.6%)
    Cystitis 2/96 (2.1%) 0/101 (0%) 0/97 (0%) 3/97 (3.1%) 2/83 (2.4%)
    Rhinitis 2/96 (2.1%) 0/101 (0%) 3/97 (3.1%) 2/97 (2.1%) 0/83 (0%)
    Injury, poisoning and procedural complications
    Fall 3/96 (3.1%) 3/101 (3%) 1/97 (1%) 2/97 (2.1%) 2/83 (2.4%)
    Arthropod sting 0/96 (0%) 2/101 (2%) 0/97 (0%) 4/97 (4.1%) 3/83 (3.6%)
    Investigations
    Blood creatine phosphokinase increased 2/96 (2.1%) 4/101 (4%) 3/97 (3.1%) 8/97 (8.2%) 6/83 (7.2%)
    Alanine aminotransferase increased 0/96 (0%) 4/101 (4%) 3/97 (3.1%) 3/97 (3.1%) 2/83 (2.4%)
    Gamma-glutamyltransferase increased 1/96 (1%) 4/101 (4%) 0/97 (0%) 4/97 (4.1%) 2/83 (2.4%)
    Aspartate aminotransferase increased 0/96 (0%) 2/101 (2%) 1/97 (1%) 3/97 (3.1%) 2/83 (2.4%)
    Metabolism and nutrition disorders
    Hyperlipidaemia 2/96 (2.1%) 0/101 (0%) 1/97 (1%) 1/97 (1%) 5/83 (6%)
    Hypoglycaemia 1/96 (1%) 1/101 (1%) 1/97 (1%) 3/97 (3.1%) 1/83 (1.2%)
    Musculoskeletal and connective tissue disorders
    Back pain 7/96 (7.3%) 5/101 (5%) 4/97 (4.1%) 7/97 (7.2%) 4/83 (4.8%)
    Arthralgia 3/96 (3.1%) 4/101 (4%) 2/97 (2.1%) 6/97 (6.2%) 3/83 (3.6%)
    Musculoskeletal pain 1/96 (1%) 3/101 (3%) 1/97 (1%) 1/97 (1%) 2/83 (2.4%)
    Osteoarthritis 3/96 (3.1%) 1/101 (1%) 3/97 (3.1%) 1/97 (1%) 0/83 (0%)
    Spinal osteoarthritis 0/96 (0%) 0/101 (0%) 3/97 (3.1%) 2/97 (2.1%) 3/83 (3.6%)
    Musculoskeletal stiffness 0/96 (0%) 1/101 (1%) 4/97 (4.1%) 2/97 (2.1%) 1/83 (1.2%)
    Pain in extremity 0/96 (0%) 3/101 (3%) 0/97 (0%) 2/97 (2.1%) 2/83 (2.4%)
    Periarthritis 4/96 (4.2%) 0/101 (0%) 0/97 (0%) 2/97 (2.1%) 1/83 (1.2%)
    Intervertebral disc protrusion 1/96 (1%) 0/101 (0%) 3/97 (3.1%) 3/97 (3.1%) 0/83 (0%)
    Arthritis 3/96 (3.1%) 1/101 (1%) 1/97 (1%) 0/97 (0%) 0/83 (0%)
    Nervous system disorders
    Headache 6/96 (6.3%) 0/101 (0%) 7/97 (7.2%) 3/97 (3.1%) 1/83 (1.2%)
    Dizziness 3/96 (3.1%) 1/101 (1%) 2/97 (2.1%) 5/97 (5.2%) 1/83 (1.2%)
    Hypoaesthesia 5/96 (5.2%) 1/101 (1%) 1/97 (1%) 1/97 (1%) 4/83 (4.8%)
    Cerebral infarction 0/96 (0%) 0/101 (0%) 3/97 (3.1%) 1/97 (1%) 0/83 (0%)
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract inflammation 8/96 (8.3%) 5/101 (5%) 7/97 (7.2%) 7/97 (7.2%) 8/83 (9.6%)
    Rhinitis allergic 2/96 (2.1%) 1/101 (1%) 3/97 (3.1%) 4/97 (4.1%) 1/83 (1.2%)
    Pharyngolaryngeal pain 2/96 (2.1%) 0/101 (0%) 3/97 (3.1%) 1/97 (1%) 0/83 (0%)
    Skin and subcutaneous tissue disorders
    Eczema 1/96 (1%) 1/101 (1%) 2/97 (2.1%) 5/97 (5.2%) 4/83 (4.8%)
    Dermatitis contact 1/96 (1%) 1/101 (1%) 2/97 (2.1%) 1/97 (1%) 4/83 (4.8%)
    Rash 0/96 (0%) 2/101 (2%) 3/97 (3.1%) 2/97 (2.1%) 0/83 (0%)
    Urticaria 0/96 (0%) 5/101 (5%) 0/97 (0%) 1/97 (1%) 0/83 (0%)
    Vascular disorders
    Hypertension 0/96 (0%) 2/101 (2%) 3/97 (3.1%) 1/97 (1%) 2/83 (2.4%)

    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:
    NCT01263496
    Other Study ID Numbers:
    • SYR-322/OCT-001
    • U1111-1118-4027
    First Posted:
    Dec 20, 2010
    Last Update Posted:
    Feb 3, 2012
    Last Verified:
    Feb 1, 2012