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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01318083
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 glimepiride
Drug: Glimepiride
Enrollment 312
Recruitment Details Participants enrolled at 33 investigative sites in Japan from 20 August 2008 to 18 April 2009.
Pre-assignment Details Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite treatment with sulfonylurea as well as diet and exercise therapies were enrolled in one of 3, once-daily (QD) or twice daily (BID) treatment groups.
Arm/Group Title Alogliptin 12.5 mg QD and Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Hide Arm/Group Description Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Period Title: Overall Study
Started 105 104 103
Completed 99 102 98
Not Completed 6 2 5
Reason Not Completed
Adverse Event             4             1             2
Withdrawal by Subject             1             0             2
Lack of Efficacy             0             0             1
Treatment Complications             1             0             0
Lack of Study Medication Compliance             0             1             0
Arm/Group Title Alogliptin 12.5 mg QD and Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID Total
Hide Arm/Group Description Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 105 104 103 312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 105 participants 104 participants 103 participants 312 participants
≤ 64 years 66 73 64 203
≥ 65 years 39 31 39 109
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 104 participants 103 participants 312 participants
Female
39
  37.1%
37
  35.6%
32
  31.1%
108
  34.6%
Male
66
  62.9%
67
  64.4%
71
  68.9%
204
  65.4%
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 or final visit and glycosylated hemoglobin collected at baseline.
Time Frame Baseline and Week 12.
Hide 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 Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Overall Number of Participants Analyzed 104 104 103
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.60  (0.563) -0.66  (0.564) 0.34  (0.611)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.936
Confidence Interval (2-Sided) 95%
-1.097 to -0.775
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.998
Confidence Interval (2-Sided) 95%
-1.160 to -0.837
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.
Hide 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 Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Overall Number of Participants Analyzed 104 104 103
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.12  (0.244) -0.13  (0.206) 0.08  (0.229)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.196
Confidence Interval (2-Sided) 95%
-0.261 to -0.131
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.213
Confidence Interval (2-Sided) 95%
-0.273 to -0.154
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.
Hide 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 Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Overall Number of Participants Analyzed 104 104 103
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.32  (0.357) -0.36  (0.339) 0.09  (0.351)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.410
Confidence Interval (2-Sided) 95%
-0.507 to -0.312
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.453
Confidence Interval (2-Sided) 95%
-0.547 to -0.358
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.
Hide 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 Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Overall Number of Participants Analyzed 104 104 103
Mean (Standard Deviation)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.52  (0.488) -0.59  (0.504) 0.18  (0.525)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.695
Confidence Interval (2-Sided) 95%
-0.834 to -0.556
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.770
Confidence Interval (2-Sided) 95%
-0.911 to -0.629
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 baseline.
Time Frame Baseline and Week 2.
Hide 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 Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Overall Number of Participants Analyzed 104 104 103
Mean (Standard Deviation)
Unit of Measure: mg/dL
-17.5  (26.05) -17.4  (29.19) 0.2  (24.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.71
Confidence Interval (2-Sided) 95%
-24.60 to -10.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.59
Confidence Interval (2-Sided) 95%
-24.93 to -10.25
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 baseline.
Time Frame Baseline and Week 4.
Hide 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 Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Overall Number of Participants Analyzed 104 104 103
Mean (Standard Deviation)
Unit of Measure: mg/dL
-21.2  (27.33) -22.9  (29.33) 2.0  (24.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.17
Confidence Interval (2-Sided) 95%
-30.33 to -16.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.88
Confidence Interval (2-Sided) 95%
-32.33 to -17.43
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 baseline.
Time Frame Baseline and Week 8.
Hide 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 Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Overall Number of Participants Analyzed 104 104 103
Mean (Standard Deviation)
Unit of Measure: mg/dL
-22.3  (26.40) -17.4  (28.88) 5.3  (29.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -27.62
Confidence Interval (2-Sided) 95%
-35.32 to -19.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.72
Confidence Interval (2-Sided) 95%
-30.76 to -14.69
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 baseline.
Time Frame Baseline and Week 12.
Hide 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 Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Overall Number of Participants Analyzed 104 104 103
Mean (Standard Deviation)
Unit of Measure: mg/dL
-22.3  (31.05) -15.9  (28.12) 6.0  (32.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -28.37
Confidence Interval (2-Sided) 95%
-37.14 to -19.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -21.93
Confidence Interval (2-Sided) 95%
-30.33 to -13.54
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 at 2 hours after the start of the meal.
Time Frame Baseline and Week 12.
Hide 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 Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Hide Arm/Group Description:
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Overall Number of Participants Analyzed 101 103 99
Mean (Standard Deviation)
Unit of Measure: mg/dL
76.6  (41.51) 80.9  (50.08) 100.0  (52.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.41
Confidence Interval (2-Sided) 95%
-36.58 to -10.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alogliptin 25 mg QD and Glimepiride QD or BID, Glimepiride 1, 2, 3 or 4 mg QD or BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.18
Confidence Interval (2-Sided) 95%
-33.40 to -4.95
Estimation Comments [Not Specified]
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of study drug and the last dose of study drug.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Alogliptin 12.5 mg QD and Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Hide Arm/Group Description Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
All-Cause Mortality
Alogliptin 12.5 mg QD and Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Alogliptin 12.5 mg QD and Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/105 (2.86%)   1/104 (0.96%)   0/103 (0.00%) 
Cardiac disorders       
Angina pectoris † 1  0/105 (0.00%)  1/104 (0.96%)  0/103 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung neoplasm malignant † 1  1/105 (0.95%)  0/104 (0.00%)  0/103 (0.00%) 
Breast cancer † 1  1/105 (0.95%)  0/104 (0.00%)  0/103 (0.00%) 
Nervous system disorders       
Cerebral infarction † 1  1/105 (0.95%)  0/104 (0.00%)  0/103 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Alogliptin 12.5 mg QD and Glimepiride QD or BID Alogliptin 25 mg QD and Glimepiride QD or BID Glimepiride 1, 2, 3 or 4 mg QD or BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   27/105 (25.71%)   40/104 (38.46%)   36/103 (34.95%) 
Infections and infestations       
Nasopharyngitis † 1  20/105 (19.05%)  20/104 (19.23%)  22/103 (21.36%) 
Gastroenteritis † 1  4/105 (3.81%)  0/104 (0.00%)  2/103 (1.94%) 
Injury, poisoning and procedural complications       
Fall † 1  1/105 (0.95%)  2/104 (1.92%)  4/103 (3.88%) 
Musculoskeletal and connective tissue disorders       
Back pain † 1  0/105 (0.00%)  4/104 (3.85%)  1/103 (0.97%) 
Nervous system disorders       
Headache † 1  0/105 (0.00%)  2/104 (1.92%)  4/103 (3.88%) 
Respiratory, thoracic and mediastinal disorders       
Upper respiratory tract inflammation † 1  2/105 (1.90%)  12/104 (11.54%)  3/103 (2.91%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: General Manager
Organization: Japan Development Center, Pharmaceutical Development Division
Phone: +81-6-6204-5257
EMail: clinicaltrialregistry@tpna.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01318083    
Other Study ID Numbers: SYR-322/CCT-005
UMIN000001393 ( Registry Identifier: UMIN-CTR )
JapicCTI-080626 ( Registry Identifier: JapicCTI )
U1111-1119-6261 ( 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