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Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00395512
Recruitment Status : Completed
First Posted : November 3, 2006
Results First Posted : March 27, 2013
Last Update Posted : March 27, 2013
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus
Interventions Drug: Alogliptin
Drug: Pioglitazone
Drug: Placebo
Enrollment 655

Recruitment Details Participants took part in the study at 268 investigative sites in 23 countries from 02 November 2006 to 13 February 2008.
Pre-assignment Details Participants with a diagnosis of type 2 diabetes who were inadequately controlled with diet and exercise were randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio as follows: Alogliptin alone, pioglitazone alone, alogliptin 25 mg + pioglitazone 30 mg and alogliptin 12.5 mg + pioglitazone 30 mg.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks. Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Period Title: Overall Study
Started 164 163 164 164
Safety Set 164 163 164 163 [1]
Completed 126 126 136 126
Not Completed 38 37 28 38
Reason Not Completed
Adverse Event             3             8             6             6
Protocol Violation             2             3             6             7
Lost to Follow-up             2             6             5             5
Withdrawal by Subject             6             5             5             12
Physician Decision             6             4             2             2
Other             1             1             0             0
Hyperglycemic Rescue             18             10             4             6
[1]
1 participant was lost to follow-up post visit 1. It is unknown if they took any study medication.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg Total
Hide Arm/Group Description Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks. Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. Total of all reporting groups
Overall Number of Baseline Participants 164 163 164 164 655
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 163 participants 164 participants 164 participants 655 participants
52.6  (10.38) 51.5  (10.72) 52.8  (11.01) 53.5  (11.37) 52.6  (10.88)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants 163 participants 164 participants 164 participants 655 participants
< 65 years 144 143 140 130 557
≥ 65 years 20 20 24 34 98
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 163 participants 164 participants 164 participants 655 participants
Female
88
  53.7%
73
  44.8%
91
  55.5%
83
  50.6%
335
  51.1%
Male
76
  46.3%
90
  55.2%
73
  44.5%
81
  49.4%
320
  48.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 163 participants 164 participants 164 participants 655 participants
Hispanic or Latino
63
  38.4%
65
  39.9%
58
  35.4%
62
  37.8%
248
  37.9%
Not Hispanic or Latino
101
  61.6%
98
  60.1%
106
  64.6%
102
  62.2%
407
  62.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 163 participants 164 participants 164 participants 655 participants
American Indian or Alaska Native
1
   0.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
Asian
14
   8.5%
15
   9.2%
12
   7.3%
16
   9.8%
57
   8.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
1
   0.2%
Black or African American
8
   4.9%
9
   5.5%
12
   7.3%
9
   5.5%
38
   5.8%
White
135
  82.3%
130
  79.8%
129
  78.7%
132
  80.5%
526
  80.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
   3.7%
9
   5.5%
11
   6.7%
6
   3.7%
32
   4.9%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 164 participants 163 participants 164 participants 164 participants 655 participants
86.72  (19.033) 85.53  (16.254) 85.39  (20.374) 84.38  (20.378) 85.50  (19.062)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 164 participants 163 participants 164 participants 164 participants 655 participants
31.61  (5.587) 30.87  (4.938) 31.32  (5.354) 30.71  (5.621) 31.13  (5.382)
Duration of diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 163 participants 164 participants 164 participants 655 participants
3.23  (3.559) 3.20  (3.739) 3.05  (3.328) 3.36  (4.166) 3.21  (3.704)
1.Primary Outcome
Title Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c)
Hide Description The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full analysis Set (all randomized patients who took at least 1 dose of double-blind study drug) where a Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 160 153 158 158
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycosylated hemoglobin
-0.96  (0.081) -1.15  (0.083) -1.71  (0.081) -1.56  (0.081)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone 30 mg, Alogliptin 25 mg + Pioglitazone 30 mg
Comments The primary efficacy variable was defined as change from Baseline in HbA1c level at Week 26. The null hypothesis was that the average change from Baseline in HbA1c at Week 26 for the A25 + P30 group would be equal to the average changes for the P30 alone and A25 alone groups; further, under the null hypothesis, the average change from Baseline in HbA1c at Week 26 for the A12.5 + P30 group was equal to the average change for the P30 alone group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-0.78 to -0.33
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg, Alogliptin 25 mg + Pioglitazone 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.75
Confidence Interval (2-Sided) 95%
-0.98 to -0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pioglitazone 30 mg, Alogliptin 12.5 mg + Pioglitazone 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.63 to -0.18
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in HbA1c Over Time
Hide Description The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at 4 week intervals during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment and geographic region as class variables and baseline HbA1c as a covariate.
Time Frame Baseline and Weeks 4, 8, 12, 16 and 20.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycosylated hemoglobin
Week 4 (n=145, 146, 144, 150) -0.55  (0.043) -0.30  (0.043) -0.62  (0.043) -0.51  (0.043)
Week 8 (n=160, 153, 158, 158) -0.84  (0.058) -0.72  (0.060) -1.19  (0.059) -1.03  (0.059)
Week 12 (n=160, 153, 158, 158) -0.98  (0.070) -1.04  (0.071) -1.57  (0.070) -1.34  (0.070)
Week 16 (n=160, 153, 158, 158) -1.01  (0.080) -1.17  (0.082) -1.67  (0.081) -1.43  (0.081)
Week 20 (n=160, 153, 158, 158) -1.00  (0.077) -1.20  (0.079) -1.72  (0.078) -1.54  (0.078)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone 30 mg, Alogliptin 12.5 mg + Pioglitazone 30 mg
Comments Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.55 to -0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pioglitazone 30 mg, Alogliptin 25 mg + Pioglitazone 30 mg
Comments Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-0.74 to -0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg, Alogliptin 25 mg + Pioglitazone 30 mg
Comments Comparison of change from Baseline at Week 20 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.73
Confidence Interval (2-Sided) 95%
-0.94 to -0.51
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose Over Time
Hide Description The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline plasma glucose as a covariate.
Time Frame Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 1 (n=148, 146, 152, 151) -14.6  (2.93) -7.3  (2.95) -26.6  (2.90) -23.3  (2.91)
Week 2 (n=161, 156, 162, 159) -16.7  (2.87) -14.2  (2.92) -33.5  (2.87) -30.9  (2.90)
Week 4 (n=162, 157, 162, 161) -26.7  (2.72) -31.9  (2.76) -41.4  (2.72) -39.7  (2.73)
Week 8 (n=162, 157, 162, 162) -29.0  (2.80) -38.0  (2.84) -50.4  (2.80) -48.4  (2.81)
Week 12 (n=162, 157, 162, 162) -29.5  (3.01) -42.4  (3.05) -51.9  (3.01) -49.3  (3.01)
Week 16 (n=162, 157, 162, 162) -26.9  (3.11) -40.6  (3.16) -52.7  (3.12) -46.6  (3.12)
Week 20 (n=162, 157, 162, 162) -28.3  (3.06) -42.0  (3.11) -54.0  (3.07) -47.5  (3.07)
Week 26 (n=162, 157, 162, 162) -25.8  (3.26) -37.3  (3.31) -50.2  (3.27) -48.5  (3.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone 30 mg, Alogliptin 12.5 mg + Pioglitazone 30 mg
Comments Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANCOVA
Comments P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -11.2
Confidence Interval (2-Sided) 95%
-20.3 to -2.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pioglitazone 30 mg, Alogliptin 25 mg + Pioglitazone 30 mg
Comments Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -12.9
Confidence Interval (2-Sided) 95%
-22.0 to -3.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg, Alogliptin 25 mg + Pioglitazone 30 mg
Comments Comparison of change from Baseline in fasting plasma glucose at Week 26 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -24.5
Confidence Interval (2-Sided) 95%
-33.5 to -15.4
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Marked Hyperglycemia
Hide Description Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL. Study week windows are defined to place hyperglycemia into visit categories.
Time Frame Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including patients with at least one non-missing fasting plasma glucose result in the specified interval in each treatment group.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 to < Week 4 (n=162, 157, 162, 161) 31.5 31.8 18.5 28.6
Week 4 to < Week 8 (n=153, 147, 148, 147) 19.0 15.0 10.8 14.3
Week 8 to < Week 12 (n=151, 146, 152, 146) 15.2 11.6 7.2 8.2
Week 12 to < Week 16 (n=153, 141, 148, 139) 16.3 9.2 8.1 7.9
Week 16 to < Week 20 (n=142, 135, 144, 131) 16.2 14.8 2.8 6.9
Week 20 to Week 26 (n=130, 132, 143, 128) 17.7 11.4 10.5 6.3
Overall (n=162, 157, 162, 162) 44.4 38.2 25.3 30.9
5.Secondary Outcome
Title Percentage of Participants Meeting Rescue Criteria
Hide Description

Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days after the first sample and analyzed by the central laboratory:

  1. After more than 4 weeks of treatment but prior to the Week 8 Visit: a single fasting plasma glucose ≥310 mg/dL (≥17.5 mmol/L);
  2. From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥275 mg/dL (≥15.27 mmol/L);
  3. From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with the Baseline HbA1c.
Time Frame Weeks 4, 8, 12, 16, 20 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including patients with visits during or after the specified interval in each treatment group.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 to < Week 8 (n=160, 156, 161, 160) 0 0 0 0.6
Week 8 to < Week 12 (n=158, 151, 157, 153) 1.3 0 0 0
Week 12 to < Week 16 (n=156, 145, 153, 144) 2.6 3.4 1.3 2.1
Week 16 to < Week 20 (n=150, 138, 149, 134) 7.3 2.2 0 1.5
Week 20 to Week 26 (n=132, 133, 146, 130) 0.8 1.5 1.4 0
Overall (n=160, 156, 161, 160) 11.3 6.4 2.5 3.8
6.Secondary Outcome
Title Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%
Hide Description Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤6.5%.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Measure Type: Number
Unit of Measure: percentage of participants
11.6 16.6 27.4 26.4
7.Secondary Outcome
Title Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%
Hide Description Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7%.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Measure Type: Number
Unit of Measure: percentage of participants
24.4 33.7 62.8 53.4
8.Secondary Outcome
Title Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.5%
Hide Description Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7.5%.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Measure Type: Number
Unit of Measure: percentage of participants
44.5 55.8 72.0 72.4
9.Secondary Outcome
Title Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 0.5%
Hide Description Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 0.5%.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Measure Type: Number
Unit of Measure: percentage of participants
66.5 70.6 89.6 85.3
10.Secondary Outcome
Title Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.0%
Hide Description Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1%.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Measure Type: Number
Unit of Measure: percentage of participants
43.3 54.6 75.6 68.1
11.Secondary Outcome
Title Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.5%.
Hide Description Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1.5%.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Measure Type: Number
Unit of Measure: percentage of participants
29.3 33.1 57.3 50.9
12.Secondary Outcome
Title Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 2.0%
Hide Description Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 2.0%.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Measure Type: Number
Unit of Measure: percentage of participants
17.7 19.6 34.1 33.1
13.Secondary Outcome
Title Change From Baseline in Fasting Proinsulin
Hide Description Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline proinsulin as a covariate.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
Week 4 (n=136, 134, 135, 145) -4.9  (1.74) -12.1  (1.75) -16.0  (1.74) -12.3  (1.68)
Week 8 (n=150, 143, 146, 155) -3.7  (1.57) -14.9  (1.60) -18.2  (1.59) -17.7  (1.54)
Week 12 (n=150, 143, 147, 155) -5.9  (1.48) -16.0  (1.52) -18.6  (1.50) -16.7  (1.46)
Week 16 (n=150, 143, 147, 155) -3.4  (1.88) -16.3  (1.93) -16.0  (1.90) -13.1  (1.85)
Week 20 (n=150, 143, 147, 155) -8.1  (1.75) -16.1  (1.79) -19.8  (1.76) -15.5  (1.72)
Week 26 (n=150, 143, 147, 155) -4.8  (1.64) -13.2  (1.68) -18.3  (1.66) -15.1  (1.61)
14.Secondary Outcome
Title Change From Baseline in Insulin
Hide Description The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline insulin as a covariate.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: μIU/mL
Week 4 (n=135, 133, 133, 145) 0.43  (0.684) -4.74  (0.689) -4.67  (0.687) -4.27  (0.659)
Week 8 (n=150, 142, 147, 155) 0.93  (0.811) -4.41  (0.834) -4.75  (0.818) -4.86  (0.797)
Week 12 (n=150, 142, 148, 155) 0.29  (0.883) -4.08  (0.907) -2.98  (0.887) -4.65  (0.867)
Week 16 (n=150, 142, 148, 155) 0.26  (0.829) -4.49  (0.852) -3.65  (0.833) -2.73  (0.814)
Week 20 (n=150, 142, 148, 155) -1.02  (0.844) -4.56  (0.868) -4.61  (0.848) -3.06  (0.829)
Week 26 (n=150, 142, 148, 155) -0.47  (0.755) -4.06  (0.776) -3.86  (0.759) -3.72  (0.742)
15.Secondary Outcome
Title Change From Baseline in Proinsulin/Insulin Ratio
Hide Description The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment and geographic region as class variables and Baseline proinsulin/insulin ratio as a covariate.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: ratio
Week 4 (n=135, 133, 133, 145) -0.073  (0.0150) -0.047  (0.0151) -0.080  (0.0151) -0.056  (0.0144)
Week 8 (n=149, 142, 146, 155) -0.041  (0.0140) -0.085  (0.0144) -0.094  (0.0142) -0.102  (0.0138)
Week 12 (n=149, 142, 147, 155) -0.062  (0.0122) -0.098  (0.0125) -0.123  (0.0123) -0.095  (0.0120)
Week 16 (n=149, 142, 147, 155) -0.049  (0.0173) -0.081  (0.0177) -0.115  (0.0174) -0.090  (0.0170)
Week 20 (n=149, 142, 147, 155) -0.057  (0.0173) -0.076  (0.0177) -0.124  (0.0174) -0.119  (0.0169)
Week 26 (n=149, 142, 147, 155) -0.051  (0.0145) -0.076  (0.0148) -0.107  (0.0146) -0.102  (0.0142)
16.Secondary Outcome
Title Change From Baseline in C-peptide Levels
Hide Description C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline C-peptide as a covariate.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
Week 4 (n=142, 141, 141, 146) 0.057  (0.0740) -0.551  (0.0741) -0.593  (0.0741) -0.452  (0.0729)
Week 8 (n=158, 150, 153, 156) 0.034  (0.0701) -0.606  (0.0718) -0.620  (0.0711) -0.547  (0.0704)
Week 12 (n=158, 150, 154, 156) -0.040  (0.0676) -0.612  (0.0693) -0.534  (0.0684) -0.536  (0.0680)
Week 16 (n=158, 150, 154, 156) 0.037  (0.0801) -0.604  (0.0822) -0.424  (0.0810) -0.353  (0.0805)
Week 20 (n=158, 150, 154, 156) -0.097  (0.0783) -0.623  (0.0803) -0.556  (0.0792) -0.374  (0.0787)
Week 26 (n=158, 150, 154, 156) -0.068  (0.0752) -0.577  (0.0771) -0.541  (0.0760) -0.444  (0.0756)
17.Secondary Outcome
Title Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance
Hide Description

The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:

HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5

A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA IR as a covariate.

Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: insulin resistance
Week 12 (n=139, 132, 137, 143) -0.814  (0.5309) -3.479  (0.5458) -2.905  (0.5348) -3.877  (0.5236)
Week 26 (n=145, 134, 144, 148) -1.353  (0.3566) -3.350  (0.3717) -3.646  (0.3579) -3.508  (0.3532)
18.Secondary Outcome
Title Change From Baseline in Homeostatic Model Assessment Beta Cell Function
Hide Description

The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.

HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5

The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA beta cell function as a covariate.

Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: percentage beta cell function
Week 12 (n= 139, 132, 137, 143) 15.133  (4.2787) 17.328  (4.3868) 30.266  (4.3006) 22.134  (4.2098)
Week 26 (n=145, 134, 144, 148) 10.472  (8.5306) 17.500  (8.8718) 39.153  (8.5455) 24.887  (8.4285)
19.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline weight as a covariate.
Time Frame Baseline and Weeks 8, 12, 20 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: kg
Week 8 (n=155, 146, 152, 151) -0.34  (0.184) 0.58  (0.189) 0.82  (0.185) 0.70  (0.186)
Week 12 (n=159, 147, 155, 154) -0.78  (0.227) 0.96  (0.236) 1.35  (0.230) 1.22  (0.230)
Week 20 (n=159, 147, 155, 154) -0.47  (0.265) 1.56  (0.275) 2.36  (0.268) 1.86  (0.269)
Week 26 (n=159, 147, 155, 154) -0.29  (0.291) 2.19  (0.302) 3.14  (0.295) 2.51  (0.296)
20.Secondary Outcome
Title Change From Baseline in Total Cholesterol Level
Hide Description Change from Baseline in total cholesterol level was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline total cholesterol as a covariate.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 4 (n=146, 144, 142, 149) -8.5  (2.22) 0.9  (2.23) -0.4  (2.25) -5.3  (2.20)
Week 8 (n=160, 151, 154, 158) -5.4  (2.30) 7.2  (2.37) -0.3  (2.34) -1.2  (2.31)
Week 12 (n=160, 151, 155, 158) -4.0  (2.43) 4.9  (2.51) -0.6  (2.47) 4.4  (2.45)
Week 16 (n=160, 151, 155, 158) -4.3  (2.42) 4.6  (2.49) 3.8  (2.46) 4.7  (2.44)
Week 20 (n=160, 151, 155, 158) -2.9  (2.67) 4.5  (2.75) -0.3  (2.71) -0.6  (2.69)
Week 26 (n=160, 151, 155, 158) -0.5  (2.61) 6.5  (2.68) 3.7  (2.65) 4.0  (2.62)
21.Secondary Outcome
Title Change From Baseline in Low-Density Lipoprotein Cholesterol
Hide Description Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL cholesterol as a covariate.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 4 (n=137, 130, 135, 142) -3.5  (1.88) 2.8  (1.93) 2.2  (1.89) -2.8  (1.85)
Week 8 (n=152, 139, 147, 153) -0.5  (1.96) 7.6  (2.05) 2.6  (1.99) 1.3  (1.95)
Week 12 (n=154, 140, 148, 154) 0.8  (2.02) 5.8  (2.12) 1.4  (2.06) 3.9  (2.02)
Week 16 (n=154, 140, 148, 154) 1.8  (2.22) 6.6  (2.33) 5.3  (2.27) 4.6  (2.22)
Week 20 (n=154, 140, 148, 154) 0.9  (2.27) 7.4  (2.38) 2.1  (2.32) 0.5  (2.27)
Week 26 (n=154, 140, 148, 154) 2.0  (2.22) 8.1  (2.33) 4.6  (2.27) 3.8  (2.22)
22.Secondary Outcome
Title Change From Baseline in High-Density Lipoprotein Cholesterol
Hide Description Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL cholesterol as a covariate.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 4 (n=146, 144, 142, 149) -0.2  (0.54) 3.0  (0.54) 3.8  (0.55) 3.0  (0.54)
Week 8 (n=160, 151, 154, 158) 0.5  (0.56) 4.7  (0.58) 5.0  (0.57) 4.8  (0.57)
Week 12 (n=160, 151, 155, 158) 0.9  (0.64) 6.0  (0.66) 6.4  (0.65) 6.5  (0.65)
Week 16 (n=160, 151, 155, 158) 0.9  (0.57) 5.2  (0.58) 6.0  (0.58) 5.9  (0.57)
Week 20 (n=160, 151, 155, 158) 0.5  (0.59) 4.7  (0.60) 5.6  (0.60) 5.6  (0.59)
Week 26 (n=160, 151, 155, 158) 0.8  (0.64) 5.7  (0.66) 6.2  (0.65) 6.2  (0.64)
23.Secondary Outcome
Title Change From Baseline in Triglyceride Levels
Hide Description Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline triglycerides as a covariate.
Time Frame Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 4 (n=146, 144, 142, 149) -28.2  (8.60) -43.2  (8.63) -51.7  (8.70) -32.1  (8.51)
Week 8 (n=160, 151, 154, 158) -34.8  (6.51) -38.2  (6.69) -61.6  (6.63) -51.9  (6.56)
Week 12 (n=160, 151, 155, 158) -36.4  (6.90) -47.9  (7.09) -64.3  (7.00) -45.4  (6.95)
Week 16 (n=160, 151, 155, 158) -44.5  (5.74) -48.3  (5.90) -54.6  (5.82) -43.9  (5.78)
Week 20 (n=160, 151, 155, 158) -29.9  (7.35) -46.6  (7.56) -59.3  (7.46) -46.5  (7.41)
Week 26 (n=160, 151, 155, 158) -24.7  (6.83) -46.6  (7.02) -56.2  (6.92) -43.1  (6.88)
24.Secondary Outcome
Title Change From Baseline in Free Fatty Acids
Hide Description Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline free fatty acid as a covariate.
Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
Week 12 (n=148, 136, 140, 147) -0.0404  (0.01643) -0.0990  (0.01716) -0.1061  (0.01690) -0.0805  (0.01650)
Week 26 (n=154, 136, 147, 150) -0.0429  (0.01624) -0.0680  (0.01729) -0.0881  (0.01662) -0.1013  (0.01647)
25.Secondary Outcome
Title Change From Baseline in Plasminogen Activator Inhibitor-1
Hide Description Change from Baseline in plasminogen activator inhibitor-1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline plasminogen activator inhibitor-1 as a covariate.
Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
Week 12 (n=136, 127, 131, 133) -1.58  (2.815) -4.23  (2.909) -9.63  (2.870) -11.87  (2.849)
Week 26 (n=145, 129, 142, 137) 1.71  (3.151) -5.45  (3.341) -7.14  (3.189) -8.38  (3.246)
26.Secondary Outcome
Title Change From Baseline in High-sensitivity C-Reactive Protein
Hide Description Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline hsCRP as a covariate.
Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
Week 12 (n=147, 134, 138, 146) -0.4497  (0.41497) -1.7446  (0.43493) -1.5346  (0.42831) -2.2771  (0.41646)
Week 26 (n=153, 135, 144, 149) -0.1851  (0.42623) -1.0391  (0.45388) -1.9763  (0.43925) -1.9796  (0.43182)
27.Secondary Outcome
Title Change From Baseline in Adiponectin
Hide Description Change from Baseline in adiponectin was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline adiponectin as a covariate.
Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: μg/mL
Week 12 (n=148, 137, 141, 147) -0.28  (0.560) 6.35  (0.582) 8.10  (0.575) 7.50  (0.562)
Week 26 (n=154, 137, 147, 149) -0.09  (0.570) 6.90  (0.605) 6.85  (0.586) 7.16  (0.581)
28.Secondary Outcome
Title Change From Baseline in Apolipoprotein A1
Hide Description Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline apolipoprotein A1 as a covariate.
Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 12 (n=140, 138, 137, 144) -1.6  (1.57) 2.3  (1.58) 1.0  (1.59) 1.7  (1.55)
Week 26 (n=149, 139, 146, 146) -4.5  (1.59) 1.2  (1.64) 0.8  (1.60) 1.6  (1.60)
29.Secondary Outcome
Title Change From Baseline in Apolipoprotein A2
Hide Description Change from Baseline in apolipoprotein A2 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein A2 as a covariate.
Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 12 (n=140, 138, 137, 144) -0.1  (0.41) 3.4  (0.41) 2.8  (0.41) 3.2  (0.40)
Week 26 (n=149, 139, 146, 146) -0.3  (0.41) 2.9  (0.43) 2.5  (0.42) 2.6  (0.42)
30.Secondary Outcome
Title Change From Baseline in Apolipoprotein B
Hide Description Change from Baseline in apolipoprotein B was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein B as a covariate.
Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 12 (n=140, 138, 137, 143) -4.0  (1.76) -5.0  (1.78) -9.8  (1.78) -5.9  (1.74)
Week 26 (n=149, 139, 146, 146) -2.5  (1.84) -3.7  (1.91) -7.9  (1.86) -6.4  (1.86)
31.Secondary Outcome
Title Change From Baseline in Apolipoprotein C-III
Hide Description Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein C-III as a covariate.
Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 12 (n=140, 138, 138, 144) -0.5  (0.30) -0.3  (0.30) -0.8  (0.30) -0.3  (0.30)
Week 26 (n=149, 139, 147, 146) -0.4  (0.28) -0.2  (0.29) -0.3  (0.28) -0.4  (0.28)
32.Secondary Outcome
Title Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides
Hide Description Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline NMR total triglycerides as a covariate.
Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 147 133 141 147
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 12 (n=139, 132, 132, 141) -14.9  (6.36) -25.0  (6.52) -39.7  (6.52) -23.7  (6.32)
Week 26 (n=147, 133, 141, 147) -7.6  (5.82) -20.2  (6.11) -28.8  (5.94) -22.6  (5.82)
33.Secondary Outcome
Title Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles
Hide Description

The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.

Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron particles as a covariate.

Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: nmol/L
Total Particles - Week 12 (n=139, 132, 132, 141) -6.59  (2.600) 0.70  (2.663) -9.63  (2.664) -2.67  (2.578)
Total Particles - Week 26 (n=147, 133, 141, 147) -4.97  (2.831) 4.94  (2.976) -0.73  (2.888) -1.17  (2.828)
Large Particles - Week 12 (n=139, 132, 132, 141) -0.94  (0.511) -1.83  (0.525) -2.63  (0.525) -2.06  (0.508)
Large Particles - Week 26 (n=147, 133, 141, 147) -0.18  (0.480) -1.96  (0.505) -2.37  (0.490) -2.11  (0.480)
34.Secondary Outcome
Title Change From Baseline in VLDL / Chylomicron Triglycerides
Hide Description

The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.

Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron triglycerides as a covariate.

Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 12 (n=139, 132, 132, 141) -14.4  (6.34) -25.6  (6.50) -39.5  (6.50) -24.2  (6.30)
Week 26 (n=147, 133, 141, 147) -8.2  (5.79) -22.0  (6.08) -29.7  (5.90) -23.3  (5.79)
35.Secondary Outcome
Title Change From Baseline in VLDL Particles
Hide Description

The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.

Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL particles as a covariate.

Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: nmol/L
Medium Particles - Week 12 (n=139, 132, 132, 141) -3.20  (1.639) -2.30  (1.678) -8.52  (1.679) -4.69  (1.625)
Medium Particles - Week 26 (n=147, 133, 141, 147) -0.23  (1.784) -0.39  (1.874) -3.76  (1.819) -3.58  (1.782)
Small Particles - Week 12 (n=139, 132, 132, 141) -1.74  (1.617) 4.77  (1.662) 1.18  (1.660) 3.71  (1.607)
Small Particles - Week 26 (n=147, 133, 141, 147) -4.11  (1.710) 7.16  (1.802) 5.22  (1.746) 4.36  (1.711)
36.Secondary Outcome
Title Change From Baseline in Mean VLDL Particle Size
Hide Description Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean VLDL particle size as a covariate.
Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: nm
Week 12 (n=139, 132, 132, 141) -0.97  (0.668) -3.97  (0.688) -2.92  (0.687) -2.85  (0.665)
Week 26 (n=147, 133, 141, 147) 0.30  (0.607) -3.71  (0.640) -4.21  (0.620) -2.80  (0.607)
37.Secondary Outcome
Title Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles
Hide Description

The change from Baseline in levels of IDL particles was assessed by NMR fractionation at Weeks 12 and 26.

Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline IDL particles as a covariate.

Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: nmol/L
Week 12 (n=139, 132, 132, 141) -2.9  (3.63) -1.0  (3.72) -2.9  (3.73) -4.0  (3.61)
Week 26 (n=147, 133, 141, 147) 0.5  (3.68) 2.1  (3.86) -1.0  (3.75) -5.8  (3.68)
38.Secondary Outcome
Title Change From Baseline in Low Density Lipoprotein (LDL) Particles
Hide Description

The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.

Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL particles as a covariate.

Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: nmol/L
Total Particles - Week 12 (n=139, 132, 132, 141) -11.9  (28.57) -104.1  (29.34) -207.0  (29.33) -181.8  (28.40)
Total Particles - Week 26 (n=147, 133, 141, 147) 60.9  (30.67) -75.6  (32.29) -169.9  (31.31) -177.1  (30.68)
Large Particles - Week 12 (n=139, 132, 132, 141) 15.3  (15.16) 98.8  (15.52) 129.4  (15.54) 142.1  (15.05)
Large Particles - Week 26 (n=147, 133, 141, 147) 2.6  (15.32) 120.4  (16.10) 146.6  (15.63) 155.5  (15.33)
Medium-Small - Week 12 (n=139, 132, 132, 141) -6.2  (6.25) -41.4  (6.41) -65.8  (6.41) -65.8  (6.20)
Medium-Small - Week 26 (n=147, 133, 141, 147) 9.9  (6.42) -40.1  (6.75) -63.0  (6.55) -66.6  (6.41)
Total Small - Week 12 (n=139, 132, 132, 141) -27.8  (31.91) -200.3  (32.71) -331.2  (32.73) -320.0  (31.66)
Total Small - Week 26 (n=147, 133, 141, 147) 54.5  (33.34) -195.8  (35.04) -313.8  (34.01) -327.4  (33.30)
Very Small - Week 12 (n=139, 132, 132, 141) -20.9  (26.22) -159.2  (26.88) -265.7  (26.90) -254.2  (26.02)
Very Small - Week 26 (n=147, 133, 141, 147) 45.1  (27.44) -156.0  (28.83) -250.9  (27.98) -260.8  (27.40)
39.Secondary Outcome
Title Change From Baseline in Mean LDL Particle Size
Hide Description Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean LDL particle size as a covariate.
Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: nm
Week 12 (n=139, 132, 132, 141) 0.09  (0.051) 0.44  (0.053) 0.63  (0.053) 0.58  (0.051)
Week 26 (n=147, 133, 141, 147) -0.02  (0.052) 0.44  (0.054) 0.65  (0.053) 0.61  (0.052)
40.Secondary Outcome
Title Change From Baseline in High Density Lipoprotein (HDL) Particles
Hide Description

The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.

Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL particles as a covariate.

Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: µmol/L
Total Particles - Week 12 (n=139, 132, 132, 141) 0.18  (0.350) 0.92  (0.359) 0.11  (0.359) 0.54  (0.348)
Total Particles - Week 26 (n=147, 133, 141, 147) 0.81  (0.359) 1.67  (0.377) 1.01  (0.367) 1.03  (0.359)
Large Particles - Week 12 (n=139, 132, 132, 141) 0.07  (0.195) 0.99  (0.200) 0.98  (0.200) 1.31  (0.193)
Large Particles - Week 26 (n=147, 133, 141, 147) -0.06  (0.197) 1.14  (0.207) 1.24  (0.201) 1.31  (0.197)
Medium Particles - Week 12 (n=139, 132, 132, 141) -0.26  (0.311) 0.72  (0.319) 1.60  (0.320) 1.61  (0.308)
Medium Particles - Week 26 (n=147, 133, 141, 147) -0.26  (0.313) 0.95  (0.329) 1.19  (0.320) 1.30  (0.312)
Small Particles - Week 12 (n=139, 132, 132, 141) 0.50  (0.412) -0.68  (0.423) -2.65  (0.423) -2.42  (0.410)
Small Particles - Week 26 (n=147, 133, 141, 147) 1.24  (0.412) -0.28  (0.433) -1.58  (0.421) -1.63  (0.413)
41.Secondary Outcome
Title Change From Baseline in Mean HDL Particle Size
Hide Description Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean HDL particle size as a covariate.
Time Frame Baseline and Weeks 12 and 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 164 163 164 163
Least Squares Mean (Standard Error)
Unit of Measure: nm
Week 12 (n=139, 132, 132, 141) -0.02  (0.024) 0.09  (0.025) 0.17  (0.025) 0.15  (0.024)
Week 26 (n=147, 133, 141, 147) -0.03  (0.024) 0.08  (0.025) 0.15  (0.024) 0.14  (0.024)
Time Frame Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
Adverse Event Reporting Description At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
 
Arm/Group Title Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Hide Arm/Group Description Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks. Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
All-Cause Mortality
Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/164 (0.61%)   6/163 (3.68%)   8/164 (4.88%)   1/163 (0.61%) 
Cardiac disorders         
Acute myocardial infarction  1  0/164 (0.00%)  0/163 (0.00%)  1/164 (0.61%)  0/163 (0.00%) 
Angina unstable  1  1/164 (0.61%)  0/163 (0.00%)  0/164 (0.00%)  0/163 (0.00%) 
Eye disorders         
Retinal detachment  1  0/164 (0.00%)  0/163 (0.00%)  1/164 (0.61%)  0/163 (0.00%) 
Gastrointestinal disorders         
Gastritis  1  0/164 (0.00%)  0/163 (0.00%)  1/164 (0.61%)  0/163 (0.00%) 
Pancreatitis  1  0/164 (0.00%)  0/163 (0.00%)  1/164 (0.61%)  0/163 (0.00%) 
General disorders         
Non-cardiac chest pain  1  0/164 (0.00%)  1/163 (0.61%)  0/164 (0.00%)  0/163 (0.00%) 
Hepatobiliary disorders         
Cholecystitis  1  0/164 (0.00%)  0/163 (0.00%)  1/164 (0.61%)  0/163 (0.00%) 
Infections and infestations         
Cervicitis  1  0/164 (0.00%)  0/163 (0.00%)  1/164 (0.61%)  0/163 (0.00%) 
Metabolism and nutrition disorders         
Hypertriglyceridaemia  1  0/164 (0.00%)  1/163 (0.61%)  0/164 (0.00%)  0/163 (0.00%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal pain  1  0/164 (0.00%)  1/163 (0.61%)  0/164 (0.00%)  0/163 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Colon cancer  1  0/164 (0.00%)  1/163 (0.61%)  0/164 (0.00%)  0/163 (0.00%) 
Nervous system disorders         
Syncope  1  0/164 (0.00%)  1/163 (0.61%)  1/164 (0.61%)  0/163 (0.00%) 
Cerebral ischaemia  1  0/164 (0.00%)  1/163 (0.61%)  0/164 (0.00%)  0/163 (0.00%) 
Renal and urinary disorders         
Haematuria  1  0/164 (0.00%)  0/163 (0.00%)  1/164 (0.61%)  0/163 (0.00%) 
Reproductive system and breast disorders         
Endometriosis  1  0/164 (0.00%)  0/163 (0.00%)  0/164 (0.00%)  1/163 (0.61%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism  1  0/164 (0.00%)  0/163 (0.00%)  1/164 (0.61%)  0/163 (0.00%) 
Vascular disorders         
Aortic stenosis  1  0/164 (0.00%)  0/163 (0.00%)  1/164 (0.61%)  0/163 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 12.5 mg + Pioglitazone 30 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/164 (11.59%)   25/163 (15.34%)   37/164 (22.56%)   24/163 (14.72%) 
General disorders         
Oedema peripheral  1  2/164 (1.22%)  9/163 (5.52%)  4/164 (2.44%)  2/163 (1.23%) 
Infections and infestations         
Urinary tract infection  1  5/164 (3.05%)  4/163 (2.45%)  9/164 (5.49%)  6/163 (3.68%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  1/164 (0.61%)  3/163 (1.84%)  10/164 (6.10%)  3/163 (1.84%) 
Nervous system disorders         
Headache  1  11/164 (6.71%)  11/163 (6.75%)  20/164 (12.20%)  14/163 (8.59%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00395512     History of Changes
Other Study ID Numbers: 01-06-TL-322OPI-002
2006-005492-17 ( EudraCT Number )
U1111-1113-8616 ( Registry Identifier: WHO )
First Submitted: November 1, 2006
First Posted: November 3, 2006
Results First Submitted: February 19, 2013
Results First Posted: March 27, 2013
Last Update Posted: March 27, 2013