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

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ClinicalTrials.gov Identifier: NCT01318122
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : September 2, 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 pioglitazone
Enrollment 336
Recruitment Details Participants enrolled at 32 investigative sites in Japan from 10 May 2008 to 03 August 2009.
Pre-assignment Details Participants who had completed the core phase 2/3 thiazolidine add on study (SYR-322/CCT-004; NCT01318070) were enrolled in one of 2, once-daily (QD) treatment groups.
Arm/Group Title CCT/004 - 12.5 mg Dose Group* → 12.5 mg Combination Group CCT/004 - 25 mg Dose Group* → 25 mg Combination Dose Group Pioglitazone Monotherapy Group* → 12.5 mg Combination Group Pioglitazone Monotherapy Group* → 25 mg Combination Group
Hide Arm/Group Description

Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.

Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.

Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.

Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.

Period Title: Enrolled - Long-Term Extension Study
Started 106 [1] 110 [1] 57 53
Completed 105 110 55 52
Not Completed 1 0 2 1
Reason Not Completed
Adverse Event             0             0             2             1
Other             1             0             0             0
[1]
5 randomized participants from alogliptin 12.5 & 25 mg group CCT-004 study did not enter this study
Period Title: Entered - Long-Term Extension Study
Started 105 110 55 52
Completed 96 99 49 48
Not Completed 9 11 6 4
Reason Not Completed
Adverse Event             6             6             2             4
Lost to Follow-up             1             0             0             0
Withdrawal by Subject             2             3             1             0
Lack of Efficacy             0             2             3             0
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Total
Hide Arm/Group Description Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. Total of all reporting groups
Overall Number of Baseline Participants 166 165 331
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 166 participants 165 participants 331 participants
≤ 64 years 116 103 219
≥ 65 years 50 62 112
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 165 participants 331 participants
Female
65
  39.2%
58
  35.2%
123
  37.2%
Male
101
  60.8%
107
  64.8%
208
  62.8%
1.Primary Outcome
Title Number of Participants With Adverse Events.
Hide Description Treatment-emergent adverse events (TEAE) are adverse events 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 that increases in severity after the start of dosing.
Time Frame 52 Weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 thiazolidine add on study (SYR-322/CCT-004 study; NCT01318070) and received at least 1 dose of the investigational products (SYR-322DB in combination with pioglitazone) for the treatment period.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 166 165
Measure Type: Number
Unit of Measure: participants
Number of Participants with Serious Adverse Event 14 11
Number of Participants with Other Adverse Event 143 146
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 165 164
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.68  (0.371) -0.73  (0.415)
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 161 163
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.81  (0.459) -0.88  (0.519)
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 158 160
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.86  (0.550) -0.92  (0.571)
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 155 160
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.84  (0.616) -0.90  (0.581)
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 155 158
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.78  (0.612) -0.82  (0.585)
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 151 156
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.75  (0.620) -0.76  (0.597)
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 150 152
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.72  (0.605) -0.72  (0.632)
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 147 151
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.67  (0.575) -0.69  (0.599)
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 147 150
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.65  (0.573) -0.66  (0.603)
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 98 101
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.70  (0.577) -0.74  (0.629)
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 98 101
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.73  (0.596) -0.76  (0.683)
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 96 100
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.77  (0.571) -0.79  (0.633)
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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 166 165
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.65  (0.597) -0.65  (0.659)
15.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (Week 8).
Hide Description The change between the value of fasting blood glucose collected at week 8 and baseline.
Time Frame Baseline and Week 8.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 165 164
Mean (Standard Deviation)
Unit of Measure: mg/dL
-15.5  (19.60) -18.1  (20.82)
16.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (Week 12).
Hide Description The change between the value of fasting blood glucose collected at week 12 and baseline.
Time Frame Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 161 163
Mean (Standard Deviation)
Unit of Measure: mg/dL
-13.4  (18.37) -16.3  (20.54)
17.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (Week 16).
Hide Description The change between the value of fasting blood glucose collected at week 6 and baseline.
Time Frame Baseline and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 158 160
Mean (Standard Deviation)
Unit of Measure: mg/dL
-11.9  (22.04) -13.4  (20.81)
18.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (Week 20).
Hide Description The change between the value of fasting blood glucose collected at week 20 and baseline.
Time Frame Baseline and Week 20.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 155 160
Mean (Standard Deviation)
Unit of Measure: mg/dL
-10.1  (21.07) -13.9  (21.74)
19.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (Week 24).
Hide Description The change between the value of fasting blood glucose collected at week 24 and baseline.
Time Frame Baseline and Week 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 155 158
Mean (Standard Deviation)
Unit of Measure: mg/dL
-10.0  (21.50) -10.7  (23.02)
20.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (Week 28).
Hide Description The change between the value of fasting blood glucose collected at week 28 and baseline.
Time Frame Baseline and Week 28.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 151 156
Mean (Standard Deviation)
Unit of Measure: mg/dL
-5.6  (28.42) -9.1  (21.27)
21.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (Week 32).
Hide Description The change between the value of fasting blood glucose collected at week 32 and baseline.
Time Frame Baseline and Week 32.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 150 152
Mean (Standard Deviation)
Unit of Measure: mg/dL
-7.9  (20.25) -10.4  (21.27)
22.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (Week 36).
Hide Description The change between the value of fasting blood glucose collected at week 36 and baseline.
Time Frame Baseline and Week 36.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 147 151
Mean (Standard Deviation)
Unit of Measure: mg/dL
-7.1  (19.65) -11.9  (18.33)
23.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (Week 40).
Hide Description The change between the value of fasting blood glucose collected at week 40 and baseline.
Time Frame Baseline and Week 40.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 147 150
Mean (Standard Deviation)
Unit of Measure: mg/dL
-9.5  (20.76) -10.6  (27.38)
24.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (Week 44).
Hide Description The change between the value of fasting blood glucose collected at week 44 and baseline.
Time Frame Baseline and Week 44.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 98 101
Mean (Standard Deviation)
Unit of Measure: mg/dL
-10.4  (17.43) -10.4  (21.24)
25.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (Week 48).
Hide Description The change between the value of fasting blood glucose collected at week 48 and baseline.
Time Frame Baseline and Week 48.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 98 101
Mean (Standard Deviation)
Unit of Measure: mg/dL
-12.2  (19.89) -14.0  (21.91)
26.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (Week 52).
Hide Description The change between the value of fasting blood glucose collected at week 52 and baseline.
Time Frame Baseline and Week 52.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 96 100
Mean (Standard Deviation)
Unit of Measure: mg/dL
-12.8  (16.63) -13.6  (26.28)
27.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (Final Visit).
Hide Description The change between the value of fasting blood glucose collected at week 52 or final visit and baseline.
Time Frame Baseline and Final Visit (up to Week 52).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 166 165
Mean (Standard Deviation)
Unit of Measure: mg/dL
-11.4  (19.29) -11.1  (25.19)
28.Secondary Outcome
Title Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
Hide Description The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time Frame Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 163 163
Mean (Standard Deviation)
Unit of Measure: mg/dL
58.3  (30.81) 49.5  (30.04)
29.Secondary Outcome
Title Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).
Hide Description The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time Frame Baseline and Week 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 104 109
Mean (Standard Deviation)
Unit of Measure: mg/dL
55.9  (30.87) 47.9  (29.20)
30.Secondary Outcome
Title Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).
Hide Description The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time Frame Baseline and Week 52.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 146 147
Mean (Standard Deviation)
Unit of Measure: mg/dL
59.1  (34.19) 57.2  (31.82)
31.Secondary Outcome
Title Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).
Hide Description The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or end of study and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time Frame Baseline and Final Visit (up to Week 52).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Overall Number of Participants Analyzed 163 163
Mean (Standard Deviation)
Unit of Measure: mg/dL
59.8  (34.26) 56.8  (32.12)
Time Frame Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through receiving 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. 5 participants from alogliptin 12.5 & 25 mg group CCT-004 study did not enter this study.
 
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Hide Arm/Group Description Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.

All-Cause Mortality
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   14/166 (8.43%)   11/165 (6.67%) 
Cardiac disorders     
Myocardial infarction  1  1/166 (0.60%)  1/165 (0.61%) 
Cardiac failure congestive  1  0/166 (0.00%)  1/165 (0.61%) 
Ear and labyrinth disorders     
Vertigo  1  1/166 (0.60%)  0/165 (0.00%) 
Eye disorders     
Cataract  1  1/166 (0.60%)  3/165 (1.82%) 
Diabetic retinopathy  1  1/166 (0.60%)  0/165 (0.00%) 
Gastrointestinal disorders     
Colonic polyp  1  1/166 (0.60%)  0/165 (0.00%) 
Duodenal ulcer  1  0/166 (0.00%)  1/165 (0.61%) 
Enterocele  1  0/166 (0.00%)  1/165 (0.61%) 
Haemorrhoids  1  1/166 (0.60%)  0/165 (0.00%) 
Infections and infestations     
Epiglottitis  1  1/166 (0.60%)  0/165 (0.00%) 
Nasopharyngitis  1  0/166 (0.00%)  1/165 (0.61%) 
Pneumonia  1  1/166 (0.60%)  0/165 (0.00%) 
Sinusitis  1  1/166 (0.60%)  0/165 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  1/166 (0.60%)  2/165 (1.21%) 
Alcohol poisoning  1  0/166 (0.00%)  1/165 (0.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  1  0/166 (0.00%)  1/165 (0.61%) 
Breast cancer  1  1/166 (0.60%)  0/165 (0.00%) 
Cervix carcinoma  1  1/166 (0.60%)  0/165 (0.00%) 
Colon cancer  1  1/166 (0.60%)  0/165 (0.00%) 
Gastric cancer  1  1/166 (0.60%)  0/165 (0.00%) 
Reproductive system and breast disorders     
Prostatitis  1  1/166 (0.60%)  0/165 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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 Pioglitazone 15 or 30 mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   143/166 (86.14%)   146/165 (88.48%) 
Eye disorders     
Diabetic retinopathy  1  7/166 (4.22%)  6/165 (3.64%) 
Conjunctivitis allergic  1  1/166 (0.60%)  5/165 (3.03%) 
Gastrointestinal disorders     
Constipation  1  4/166 (2.41%)  11/165 (6.67%) 
Gastritis  1  6/166 (3.61%)  8/165 (4.85%) 
General disorders     
Oedema peripheral  1  4/166 (2.41%)  7/165 (4.24%) 
Oedema  1  2/166 (1.20%)  6/165 (3.64%) 
Infections and infestations     
Nasopharyngitis  1  54/166 (32.53%)  54/165 (32.73%) 
Bronchitis  1  8/166 (4.82%)  2/165 (1.21%) 
Pharyngitis  1  4/166 (2.41%)  6/165 (3.64%) 
Injury, poisoning and procedural complications     
Contusion  1  7/166 (4.22%)  5/165 (3.03%) 
Fall  1  6/166 (3.61%)  5/165 (3.03%) 
Investigations     
Blood creatine phosphokinase increased  1  16/166 (9.64%)  15/165 (9.09%) 
Brain natriuretic peptide increased  1  8/166 (4.82%)  6/165 (3.64%) 
Blood pressure increased  1  0/166 (0.00%)  6/165 (3.64%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  12/166 (7.23%)  8/165 (4.85%) 
Arthralgia  1  2/166 (1.20%)  15/165 (9.09%) 
Periarthritis  1  6/166 (3.61%)  5/165 (3.03%) 
Pain in extremity  1  5/166 (3.01%)  4/165 (2.42%) 
Nervous system disorders     
Headache  1  5/166 (3.01%)  6/165 (3.64%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract inflammation  1  13/166 (7.83%)  9/165 (5.45%) 
Skin and subcutaneous tissue disorders     
Eczema  1  7/166 (4.22%)  7/165 (4.24%) 
Vascular disorders     
Hypertension  1  6/166 (3.61%)  2/165 (1.21%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
331 participants were randomized in the core phase 2/3 thiazolidine (CCT-004) study and included in the Full Analysis Set in this study. 5 participants from CCT-004 study did not enter this study.
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: NCT01318122     History of Changes
Other Study ID Numbers: SYR-322/OCT-004
U1111-1119-6207 ( Registry Identifier: WHO )
First Submitted: March 16, 2011
First Posted: March 18, 2011
Results First Submitted: June 8, 2011
Results First Posted: September 2, 2011
Last Update Posted: February 3, 2012