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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01263509
Recruitment Status : Completed
First Posted : December 20, 2010
Results First Posted : August 29, 2011
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Intervention Drug: Alogliptin and voglibose
Enrollment 179
Recruitment Details Participants enrolled at 24 investigative sites in Japan from 06 June 2007 to 02 October 2008.
Pre-assignment Details Participants enrolled in one of 2, once-daily (QD) or three-times daily (TID) treatment groups. Analyses performed by treatment group or treatment dose in this study. All 213 participants randomized in the phase 2/3 α-glucosidase inhibitor (NCT01263483) study are included in the Full Analysis Set in this study, of which 179 randomized.
Arm/Group Title 12.5 mg Combination Dose Group* → 12.5 mg Combination Group 25 mg Combination Dose Group* → 25 mg Combination Dose Group α-glucosidase Monotherapy Group* → 12.5 mg Combination Group α-glucosidase Monotherapy Group*→ 25 mg Combination Group
Hide Arm/Group Description

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 combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on 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 for 25 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on 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 α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on 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 α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study.

Period Title: Enrolled - Long-Term Extension Study
Started 61 60 32 26
Completed 61 60 32 26
Not Completed 0 0 0 0
Period Title: Entered - Long-Term Extension Study
Started 61 60 32 26
Completed 53 48 27 24
Not Completed 8 12 5 2
Reason Not Completed
Adverse Event             5             5             4             1
Lack of Efficacy             1             4             1             0
Withdrawal by Subject             1             2             0             0
Participant Unavailability             1             1             0             0
Poor Glycosylated Hemoglobin Control             0             0             0             1
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID Total
Hide Arm/Group Description Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. Total of all reporting groups
Overall Number of Baseline Participants 108 105 213
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants 105 participants 213 participants
≤ 64 years 69 53 122
≥ 65 years 39 52 91
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 105 participants 213 participants
Female
44
  40.7%
38
  36.2%
82
  38.5%
Male
64
  59.3%
67
  63.8%
131
  61.5%
1.Primary Outcome
Title Number of Participants With Adverse Events.
Hide 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.
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Adverse Event Profile in the Safety Analysis Set
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 108 105
Measure Type: Number
Unit of Measure: participants
Serious Adverse Event 6 7
Serious Adverse Event Related to Study Drug 0 1
Other Adverse Events (Incidence ≥3%) 85 73
2.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 8).
Hide Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.
Time Frame Baseline and Week 8.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 107 100
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.69  (0.479) -0.79  (0.417)
3.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 12).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 106 99
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.89  (0.589) -0.96  (0.486)
4.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 16).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 91 84
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.91  (0.658) -0.96  (0.587)
5.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 20).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 90 83
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.90  (0.745) -0.89  (0.592)
6.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 24).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.83  (0.750) -0.88  (0.624)
7.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 28).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 88 82
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.81  (0.704) -0.89  (0.619)
8.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 32).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 86 82
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.80  (0.701) -0.85  (0.679)
9.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 36).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 84 78
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.82  (0.717) -0.90  (0.649)
10.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 40).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.78  (0.742) -0.92  (0.672)
11.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 44).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 53 51
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.88  (0.721) -0.94  (0.545)
12.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 48).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 53 49
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.92  (0.694) -0.94  (0.548)
13.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 52).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 53 48
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.95  (0.692) -0.95  (0.568)
14.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Final Visit).
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 108 105
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.81  (0.714) -0.89  (0.660)
15.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 8).
Hide Description The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
Time Frame Baseline and Week 8.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 107 100
Mean (Standard Deviation)
Unit of Measure: mg/dL
-18.2  (22.43) -20.4  (23.04)
16.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 12).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 106 99
Mean (Standard Deviation)
Unit of Measure: mg/dL
-17.1  (22.02) -18.8  (24.26)
17.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 16).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 91 84
Mean (Standard Deviation)
Unit of Measure: mg/dL
-16.0  (23.84) -15.3  (23.33)
18.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 20).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 90 83
Mean (Standard Deviation)
Unit of Measure: mg/dL
-15.6  (23.90) -15.0  (26.34)
19.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 24).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: mg/dL
-13.8  (23.96) -15.6  (26.84)
20.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 28).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 88 82
Mean (Standard Deviation)
Unit of Measure: mg/dL
-14.5  (22.77) -21.9  (23.68)
21.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 32).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 86 82
Mean (Standard Deviation)
Unit of Measure: mg/dL
-17.7  (20.75) -20.1  (29.84)
22.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 36).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 83 78
Mean (Standard Deviation)
Unit of Measure: mg/dL
-17.3  (22.93) -22.6  (27.10)
23.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 40).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: mg/dL
-19.7  (22.88) -22.8  (23.49)
24.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 44).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 53 51
Mean (Standard Deviation)
Unit of Measure: mg/dL
-21.5  (19.63) -24.4  (26.01)
25.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 48).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 53 49
Mean (Standard Deviation)
Unit of Measure: mg/dL
-20.5  (21.12) -23.1  (27.16)
26.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 52).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 53 48
Mean (Standard Deviation)
Unit of Measure: mg/dL
-20.7  (20.37) -24.0  (20.98)
27.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Final Visit).
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 108 105
Mean (Standard Deviation)
Unit of Measure: mg/dL
-17.5  (23.45) -23.3  (26.35)
28.Secondary Outcome
Title Change From Baseline in Fasting C-peptide (Week 8).
Hide Description The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.
Time Frame Baseline and Week 8.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 107 100
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.05  (0.701) 0.11  (0.680)
29.Secondary Outcome
Title Change From Baseline in Fasting C-peptide (Week 12).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 106 99
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.10  (0.743) 0.13  (0.603)
30.Secondary Outcome
Title Change From Baseline in Fasting C-peptide (Week 16).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 91 84
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.24  (0.761) 0.21  (0.597)
31.Secondary Outcome
Title Change From Baseline in Fasting C-peptide (Week 20).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 87 83
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.24  (0.840) 0.15  (0.801)
32.Secondary Outcome
Title Change From Baseline in Fasting C-peptide (Week 24).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 81 76
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.19  (0.897) 0.14  (0.723)
33.Secondary Outcome
Title Change From Baseline in Fasting C-peptide (Week 28).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 70 71
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.18  (0.984) 0.25  (0.788)
34.Secondary Outcome
Title Change From Baseline in Fasting C-peptide (Week 32).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 58 63
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.47  (0.895) 0.31  (0.799)
35.Secondary Outcome
Title Change From Baseline in Fasting C-peptide (Week 36).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 37 39
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.33  (0.695) 0.38  (0.654)
36.Secondary Outcome
Title Change From Baseline in Fasting C-peptide (Week 40).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.30  (0.701) 0.37  (0.604)
37.Secondary Outcome
Title Change From Baseline in Fasting C-peptide (Week 44).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 11 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.08  (0.698) 0.25  (0.477)
38.Secondary Outcome
Title Change From Baseline in Fasting C-peptide (Week 48).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.45  (0.058) 0.38  (0.340)
39.Secondary Outcome
Title Change From Baseline in Fasting C-peptide (Week 52).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 3 1
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.80  (0.600) 0.40
40.Secondary Outcome
Title Change From Baseline in Fasting C-peptide (Final Visit).
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 108 105
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.31  (0.821) 0.29  (0.879)
41.Secondary Outcome
Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 106 100
Mean (Standard Deviation)
Unit of Measure: mg/dL
41.2  (25.19) 37.6  (32.67)
42.Secondary Outcome
Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 62 58
Mean (Standard Deviation)
Unit of Measure: mg/dL
38.0  (29.04) 37.1  (33.84)
43.Secondary Outcome
Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 82 77
Mean (Standard Deviation)
Unit of Measure: mg/dL
39.0  (25.71) 40.8  (29.49)
44.Secondary Outcome
Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 106 101
Mean (Standard Deviation)
Unit of Measure: mg/dL
39.6  (26.16) 39.4  (29.46)
45.Secondary Outcome
Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 105 98
Mean (Standard Deviation)
Unit of Measure: mg•hr/dL
-73.2  (63.40) -76.8  (58.92)
46.Secondary Outcome
Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 62 58
Mean (Standard Deviation)
Unit of Measure: mg•hr/dL
-69.0  (61.21) -70.4  (68.54)
47.Secondary Outcome
Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 81 76
Mean (Standard Deviation)
Unit of Measure: mg•hr/dL
-83.5  (58.30) -83.4  (53.80)
48.Secondary Outcome
Title Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 105 99
Mean (Standard Deviation)
Unit of Measure: mg•hr/dL
-77.5  (61.67) -82.2  (62.58)
49.Secondary Outcome
Title Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 99 92
Mean (Standard Deviation)
Unit of Measure: μU•hr/mL
3.05  (15.254) 2.95  (15.704)
50.Secondary Outcome
Title Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 59 55
Mean (Standard Deviation)
Unit of Measure: μU•hr/mL
4.42  (13.445) 2.26  (13.455)
51.Secondary Outcome
Title Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 75 71
Mean (Standard Deviation)
Unit of Measure: μU•hr/mL
-1.28  (10.220) 0.18  (12.425)
52.Secondary Outcome
Title Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 99 93
Mean (Standard Deviation)
Unit of Measure: μU•hr/mL
-0.61  (11.454) 0.01  (12.567)
53.Secondary Outcome
Title Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 106 98
Mean (Standard Deviation)
Unit of Measure: ng•hr/mL
0.71  (2.062) 0.71  (2.209)
54.Secondary Outcome
Title Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
Hide 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.
Hide Outcome Measure Data
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Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 61 58
Mean (Standard Deviation)
Unit of Measure: ng•hr/mL
1.38  (1.845) 1.12  (2.238)
55.Secondary Outcome
Title Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
Hide 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.
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Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: ng•hr/mL
0.96  (1.028) 2.18  (3.384)
56.Secondary Outcome
Title Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
Hide 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).
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Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 106 99
Mean (Standard Deviation)
Unit of Measure: ng•hr/mL
1.05  (2.089) 0.80  (2.354)
57.Secondary Outcome
Title Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
Hide 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.
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Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 106 99
Mean (Standard Deviation)
Unit of Measure: pg•hr/mL
-14.3  (42.23) -20.0  (47.18)
58.Secondary Outcome
Title Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
Hide 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.
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Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 62 58
Mean (Standard Deviation)
Unit of Measure: pg•hr/mL
-4.6  (53.17) -6.8  (36.78)
59.Secondary Outcome
Title Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 82 76
Mean (Standard Deviation)
Unit of Measure: pg•hr/mL
-12.0  (64.24) -22.2  (49.67)
60.Secondary Outcome
Title Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Values are Summary Statistics.
Arm/Group Title Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Overall Number of Participants Analyzed 106 100
Mean (Standard Deviation)
Unit of Measure: pg•hr/mL
-11.7  (59.01) -20.9  (50.57)
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Hide Arm/Group Description Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
All-Cause Mortality
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Affected / at Risk (%) Affected / at Risk (%)
Total   6/108 (5.56%)   7/105 (6.67%) 
Cardiac disorders     
Angina pectoris  1  1/108 (0.93%)  0/105 (0.00%) 
Ear and labyrinth disorders     
Vertigo positional  1  0/108 (0.00%)  1/105 (0.95%) 
Gastrointestinal disorders     
Salivary gland calculus  1  1/108 (0.93%)  0/105 (0.00%) 
Infections and infestations     
Pneumonia  1  0/108 (0.00%)  1/105 (0.95%) 
Pyelonephritis acute  1  0/108 (0.00%)  1/105 (0.95%) 
Injury, poisoning and procedural complications     
Fall  1  0/108 (0.00%)  1/105 (0.95%) 
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis  1  1/108 (0.93%)  0/105 (0.00%) 
Osteoarthritis  1  1/108 (0.93%)  0/105 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  1/108 (0.93%)  1/105 (0.95%) 
Gastric cancer  1  1/108 (0.93%)  1/105 (0.95%) 
Bladder neoplasm  1  1/108 (0.93%)  0/105 (0.00%) 
Nervous system disorders     
Transient ischaemic attack  1  0/108 (0.00%)  1/105 (0.95%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Affected / at Risk (%) Affected / at Risk (%)
Total   85/108 (78.70%)   73/105 (69.52%) 
Gastrointestinal disorders     
Diarrhoea  1  5/108 (4.63%)  3/105 (2.86%) 
Gastritis  1  1/108 (0.93%)  4/105 (3.81%) 
Abdominal distension  1  4/108 (3.70%)  0/105 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  4/108 (3.70%)  0/105 (0.00%) 
Immune system disorders     
Seasonal allergy  1  6/108 (5.56%)  1/105 (0.95%) 
Infections and infestations     
Nasopharyngitis  1  38/108 (35.19%)  30/105 (28.57%) 
Bronchitis  1  6/108 (5.56%)  3/105 (2.86%) 
Cystitis  1  4/108 (3.70%)  2/105 (1.90%) 
Pharyngitis  1  1/108 (0.93%)  4/105 (3.81%) 
Injury, poisoning and procedural complications     
Contusion  1  5/108 (4.63%)  3/105 (2.86%) 
Fall  1  4/108 (3.70%)  2/105 (1.90%) 
Investigations     
Gamma-glutamyltransferase increased  1  4/108 (3.70%)  0/105 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  8/108 (7.41%)  6/105 (5.71%) 
Arthralgia  1  2/108 (1.85%)  5/105 (4.76%) 
Spinal osteoarthritis  1  0/108 (0.00%)  5/105 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract inflammation  1  12/108 (11.11%)  5/105 (4.76%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  4/108 (3.70%)  0/105 (0.00%) 
Urticaria  1  4/108 (3.70%)  0/105 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01263509     History of Changes
Other Study ID Numbers: SYR-322/OCT-003
U1111-1118-3992 ( Registry Identifier: WHO )
First Submitted: December 17, 2010
First Posted: December 20, 2010
Results First Submitted: June 8, 2011
Results First Posted: August 29, 2011
Last Update Posted: February 3, 2012