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

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ClinicalTrials.gov Identifier: NCT01318070
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : July 6, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Alogliptin and pioglitazone
Drug: Pioglitazone
Enrollment 339

Recruitment Details Participants enrolled at 33 investigative sites in Japan from 22 November 2007 to 22 October 2008.
Pre-assignment Details Participants with historical diagnosis of type 2 diabetes with uncontrolled blood glucose despite treatment with pioglitazone as well as diet and exercise therapies were enrolled in one of 3, once-daily (QD) treatment groups.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Hide Arm/Group Description Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks. Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks. Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Period Title: Overall Study
Started 111 113 115
Completed 109 111 108
Not Completed 2 2 7
Reason Not Completed
Adverse Event             1             1             5
Withdrawal by Subject             0             1             1
Lack of Efficacy             0             0             1
Principal Investigator Discretion             1             0             0
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD Total
Hide Arm/Group Description Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks. Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks. Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 111 113 115 339
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 111 participants 113 participants 115 participants 339 participants
≤ 64 years 77 70 77 224
≥ 65 years 34 43 38 115
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 113 participants 115 participants 339 participants
Female
44
  39.6%
43
  38.1%
39
  33.9%
126
  37.2%
Male
67
  60.4%
70
  61.9%
76
  66.1%
213
  62.8%
1.Primary 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
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Overall Number of Participants Analyzed 111 113 115
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.91  (0.441) -0.97  (0.517) -0.19  (0.552)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.717
Confidence Interval (2-Sided) 95%
-0.848 to -0.586
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.773
Confidence Interval (2-Sided) 95%
-0.913 to -0.634
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 2).
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 2 and glycosylated hemoglobin collected at baseline.
Time Frame Baseline and Week 2.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Overall Number of Participants Analyzed 110 111 115
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.22  (0.150) -0.22  (0.154) -0.04  (0.186)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.179
Confidence Interval (2-Sided) 95%
-0.224 to -0.135
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.180
Confidence Interval (2-Sided) 95%
-0.225 to -0.135
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 4).
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 4 and glycosylated hemoglobin collected at baseline.
Time Frame Baseline and Week 4.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Overall Number of Participants Analyzed 111 113 115
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.47  (0.236) -0.46  (0.254) -0.10  (0.301)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.363
Confidence Interval (2-Sided) 95%
-0.434 to -0.292
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.359
Confidence Interval (2-Sided) 95%
-0.432 to -0.287
Estimation Comments [Not Specified]
4.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
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Overall Number of Participants Analyzed 111 113 115
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.76  (0.353) -0.81  (0.398) -0.17  (0.433)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.588
Confidence Interval (2-Sided) 95%
-0.692 to -0.484
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.635
Confidence Interval (2-Sided) 95%
-0.743 to -0.526
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 2).
Hide Description The change between the value of fasting plasma glucose collected at week 2 and glycosylated hemoglobin collected at baseline.
Time Frame Baseline and Week 2.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Overall Number of Participants Analyzed 110 113 115
Mean (Standard Deviation)
Unit of Measure: mg/dL
-12.8  (14.68) -17.0  (18.36) -3.9  (18.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.83
Confidence Interval (2-Sided) 95%
-13.20 to -4.47
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.06
Confidence Interval (2-Sided) 95%
-17.86 to -8.26
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 4).
Hide Description The change between the value of fasting plasma glucose collected at week 4 and glycosylated hemoglobin collected at baseline.
Time Frame Baseline and Week 4.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Overall Number of Participants Analyzed 111 113 115
Mean (Standard Deviation)
Unit of Measure: mg/dL
-14.4  (18.45) -17.9  (20.16) -3.1  (19.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.24
Confidence Interval (2-Sided) 95%
-16.22 to -6.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.82
Confidence Interval (2-Sided) 95%
-20.00 to -9.63
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 8).
Hide Description The change between the value of fasting plasma glucose collected at week 8 and glycosylated hemoglobin collected at baseline.
Time Frame Baseline and Week 8.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Overall Number of Participants Analyzed 111 113 115
Mean (Standard Deviation)
Unit of Measure: mg/dL
-17.1  (16.96) -21.3  (20.20) -4.2  (22.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.88
Confidence Interval (2-Sided) 95%
-18.09 to -7.68
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.08
Confidence Interval (2-Sided) 95%
-22.64 to -11.53
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 12).
Hide Description The change between the value of fasting plasma glucose collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.
Time Frame Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Overall Number of Participants Analyzed 111 113 115
Mean (Standard Deviation)
Unit of Measure: mg/dL
-14.9  (18.42) -18.9  (20.96) -2.4  (26.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.46
Confidence Interval (2-Sided) 95%
-18.51 to -6.40
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.49
Confidence Interval (2-Sided) 95%
-22.78 to -10.19
Estimation Comments [Not Specified]
9.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 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 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
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Hide Arm/Group Description:
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Overall Number of Participants Analyzed 110 111 109
Mean (Standard Deviation)
Unit of Measure: mg/dL
58.3  (28.75) 49.4  (29.27) 70.6  (39.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.31
Confidence Interval (2-Sided) 95%
-21.51 to -3.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD, Pioglitazone 15 mg or 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -21.19
Confidence Interval (2-Sided) 95%
-30.43 to -11.95
Estimation Comments [Not Specified]
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.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Hide Arm/Group Description Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks. Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks. Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
All-Cause Mortality
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/111 (0.90%)   2/113 (1.77%)   5/115 (4.35%) 
Eye disorders       
Cataract  1  0/111 (0.00%)  1/113 (0.88%)  1/115 (0.87%) 
Infections and infestations       
Bronchopneumonia  1  0/111 (0.00%)  0/113 (0.00%)  1/115 (0.87%) 
Nasopharyngitis  1  0/111 (0.00%)  1/113 (0.88%)  0/115 (0.00%) 
Injury, poisoning and procedural complications       
Fall  1  1/111 (0.90%)  0/113 (0.00%)  0/115 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Gallbladder cancer  1  0/111 (0.00%)  0/113 (0.00%)  1/115 (0.87%) 
Nervous system disorders       
Cerebral infarction  1  0/111 (0.00%)  0/113 (0.00%)  1/115 (0.87%) 
Dizziness  1  0/111 (0.00%)  0/113 (0.00%)  1/115 (0.87%) 
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 30mg QD Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Pioglitazone 15 mg or 30 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/111 (4.50%)   17/113 (15.04%)   13/115 (11.30%) 
Gastrointestinal disorders       
Dental caries  1  0/111 (0.00%)  0/113 (0.00%)  4/115 (3.48%) 
Infections and infestations       
Nasopharyngitis  1  5/111 (4.50%)  13/113 (11.50%)  6/115 (5.22%) 
Investigations       
Blood creatine phosphokinase increased  1  0/111 (0.00%)  4/113 (3.54%)  3/115 (2.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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: NCT01318070     History of Changes
Other Study ID Numbers: SYR-322/CCT-004
UMIN000001382 ( Registry Identifier: UMIN-CTR )
JapicCTI-080590 ( Registry Identifier: JapicCTI )
U1111-1118-4073 ( Registry Identifier: WHO )
First Submitted: March 16, 2011
First Posted: March 18, 2011
Results First Submitted: June 8, 2011
Results First Posted: July 6, 2011
Last Update Posted: February 3, 2012