ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.

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: NCT00755846
Recruitment Status : Completed
First Posted : September 19, 2008
Results First Posted : August 29, 2011
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus
Interventions Drug: Alogliptin
Drug: Placebo
Enrollment 265
Recruitment Details Participants enrolled at 62 sites in Chile and the United States from 17 March 2005 to 10 June 2005.
Pre-assignment Details Participants with a historical diagnosis of type 2 diabetes mellitus who were either receiving no current treatment or currently treated with diet and exercise, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin enrolled in once daily (QD) groups.
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Period Title: Overall Study
Started 43 44 44 45 44 45
Completed 18 27 32 32 27 31
Not Completed 25 17 12 13 17 14
Reason Not Completed
Adverse Event             0             0             0             1             3             2
Protocol Violation             1             1             1             1             1             1
Lost to Follow-up             0             2             1             0             4             2
Withdrawal by Subject             2             3             5             2             0             1
Hyperglycemic Rescue             21             7             5             8             8             7
Physician Decision             1             3             0             1             0             1
Administrative Error             0             1             0             0             0             0
Participant Non-compliance             0             0             0             0             1             0
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD Total
Hide Arm/Group Description Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 43 44 44 45 44 45 265
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 44 participants 44 participants 45 participants 44 participants 45 participants 265 participants
<65 years 33 38 33 36 31 34 205
≥65 years 10 6 11 9 13 11 60
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 44 participants 44 participants 45 participants 44 participants 45 participants 265 participants
Female
24
  55.8%
25
  56.8%
22
  50.0%
17
  37.8%
26
  59.1%
25
  55.6%
139
  52.5%
Male
19
  44.2%
19
  43.2%
22
  50.0%
28
  62.2%
18
  40.9%
20
  44.4%
126
  47.5%
1.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85.
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 day 85 or final visit and glycosylated hemoglobin collected at baseline.
Time Frame Baseline and Day 85.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 41 42 42 45 43 44
Least Squares Mean (Standard Error)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.01  (0.135) -0.19  (0.121) -0.54  (0.122) -0.56  (0.117) -0.44  (0.124) -0.51  (0.119)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.43
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.135
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.171
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.176
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.170
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.174
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.307
Comments A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.173
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
2.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin at Day 43.
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 day 43 and glycosylated hemoglobin collected at baseline.
Time Frame Baseline and Day 43.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 41 42 42 44 43 44
Least Squares Mean (Standard Error)
Unit of Measure: percentage of Glycosylated Hemoglobin
0.02  (0.097) -0.12  (0.095) -0.35  (0.096) -0.36  (0.093) -0.32  (0.097) -0.31  (0.094)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.106
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.134
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.138
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.134
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.137
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.321
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.136
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
3.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Day 43).
Hide Description The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline.
Time Frame Baseline and Day 43
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 41 42 42 45 43 44
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
4.9  (6.09) -7.3  (6.00) -11.5  (6.02) -24.5  (5.80) -17.9  (6.10) -25.6  (5.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting plasma glucose (FPG). The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration, and baseline FPG as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.65
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -30.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.40
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.68
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -29.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.38
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.57
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.156
Comments No multiplicity adjustments
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.56
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Day 85).
Hide Description The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline.
Time Frame Baseline and Day 85.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 41 42 42 45 43 44
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
8.5  (6.45) -7.8  (6.36) -5.1  (6.39) -27.0  (6.14) -16.1  (6.47) -20.9  (6.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between all doses of alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.05
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -29.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.91
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.20
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and body mass index, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -35.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.88
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.136
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.09
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.07
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
5.Secondary Outcome
Title Change From Baseline in Fasting Fructosamine (Day 43).
Hide Description The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline.
Time Frame Baseline and Day 43.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 39 41 42 43 39 43
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
7.6  (5.35) -4.2  (5.16) -13.1  (5.12) -14.5  (5.05) -16.3  (5.47) -11.7  (5.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.85
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.37
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.71
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.33
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.44
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.45
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
6.Secondary Outcome
Title Change From Baseline in Fasting Fructosamine (Day 85).
Hide Description The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline.
Time Frame Baseline and Day 85.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 41 42 42 45 40 44
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
7.7  (6.03) 0.2  (5.91) -9.8  (5.93) -16.4  (5.71) -12.4  (6.25) -4.8  (5.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.60
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.136
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.35
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.73
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.26
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.48
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.378
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.47
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
7.Secondary Outcome
Title Change From Baseline in Total Cholesterol (Day 43).
Hide Description The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline.
Time Frame Baseline and Day 43
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 40 41 42 43 39 42
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-11.1  (4.91) -9.7  (4.85) -9.6  (4.77) -9.8  (4.71) -12.0  (5.11) -4.7  (4.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.718
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.37
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.346
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.80
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.901
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.13
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.851
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.79
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.825
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.86
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.843
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.94
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
8.Secondary Outcome
Title Change From Baseline in Total Cholesterol (Day 85).
Hide Description The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline.
Time Frame Baseline and Day 85.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 41 42 42 45 40 44
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-15.1  (4.46) -9.0  (4.41) -4.8  (4.39) -8.7  (4.24) -7.7  (4.64) -0.4  (4.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.88
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.14
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.258
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.47
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.299
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.13
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.27
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.340
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.32
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
9.Secondary Outcome
Title Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43).
Hide Description The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline.
Time Frame Baseline and Day 43.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 40 41 42 43 39 42
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-1.4  (0.76) -0.6  (0.75) -2.0  (0.74) -2.4  (0.73) -2.8  (0.80) -1.1  (0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.689
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.83
Estimation Comments Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.742
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.05
Estimation Comments Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.220
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.11
Estimation Comments Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.348
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.05
Estimation Comments Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.627
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.06
Estimation Comments Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.418
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.06
Estimation Comments Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.
10.Secondary Outcome
Title Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85).
Hide Description The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline.
Time Frame Baseline and Day 85.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 41 42 42 45 40 44
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-1.9  (0.87) -0.7  (0.86) -2.3  (0.85) -2.5  (0.83) -2.0  (0.92) 0.4  (0.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.617
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.95
Estimation Comments Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.20
Estimation Comments Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.906
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.28
Estimation Comments Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.628
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.19
Estimation Comments Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.749
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.22
Estimation Comments Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.340
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.22
Estimation Comments Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.
11.Secondary Outcome
Title Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43).
Hide Description The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline.
Time Frame Baseline and Day 43.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 35 38 39 40 36 37
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-8.9  (3.97) -3.8  (3.79) -6.4  (3.72) -1.5  (3.69) -9.9  (4.01) 0.8  (3.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.269
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.31
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.46
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.867
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.66
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.169
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.40
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.645
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.45
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.351
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.51
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
12.Secondary Outcome
Title Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85).
Hide Description The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline.
Time Frame Baseline and Day 85.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 36 39 39 43 38 40
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-13.6  (3.72) -2.6  (3.55) -2.7  (3.54) -0.6  (3.38) -5.0  (3.70) 4.0  (3.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.03
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 17.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.06
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.26
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.98
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.14
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.16
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
13.Secondary Outcome
Title Change From Baseline in Triglycerides (Day 43).
Hide Description The change between triglycerides collected at day 43 and triglycerides collected at baseline.
Time Frame Baseline and Day 43.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 40 41 42 43 39 42
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-18.7  (15.69) -28.0  (15.43) -10.1  (15.28) -27.7  (15.10) -7.2  (16.33) -31.5  (15.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.897
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 17.17
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.557
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 21.85
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.616
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 22.85
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.679
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 21.73
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.697
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 21.94
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.672
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 22.03
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
14.Secondary Outcome
Title Change From Baseline in Triglycerides (Day 85).
Hide Description The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline.
Time Frame Baseline and Day 85.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 41 42 42 45 40 44
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-13.9  (14.98) -26.4  (14.75) 9.2  (14.77) -32.9  (14.27) -14.4  (15.58) -24.9  (14.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD, Alogliptin 12.5 mg QD, Alogliptin 25 mg QD, Alogliptin 50 mg QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.809
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 16.37
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 100 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.597
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 20.74
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 50 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.982
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 21.77
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.358
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 20.62
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.274
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 23.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 21.06
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 6.25 mg QD
Comments The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.554
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 21.06
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
15.Secondary Outcome
Title Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL).
Hide Description The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population.
Time Frame 85 Days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Randomized participants who received at least 1 dose of study drug (Intent to Treat), and who had at least 1 fasting plasma glucose measurement after baseline.

Note: Mean percent incidence of marked hyperglycemia was only summarized by treatment group using descriptive statistics.

Arm/Group Title Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 41 42 42 45 43 44
Mean (Standard Deviation)
Unit of Measure: percent incidence
54.0  (34.95) 34.7  (33.43) 25.8  (26.92) 28.1  (25.94) 30.4  (30.32) 30.6  (29.92)
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Hide Arm/Group Description Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks. Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
All-Cause Mortality
Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/41 (4.88%)   1/42 (2.38%)   0/44 (0.00%)   1/45 (2.22%)   0/43 (0.00%)   0/44 (0.00%) 
General disorders             
Noncardiac chest pain  1  0/41 (0.00%)  1/42 (2.38%)  0/44 (0.00%)  1/45 (2.22%)  0/43 (0.00%)  0/44 (0.00%) 
Injury, poisoning and procedural complications             
Intentional overdose  1  1/41 (2.44%)  0/42 (0.00%)  0/44 (0.00%)  0/45 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Musculoskeletal and connective tissue disorders             
Osteoarthritis  1  1/41 (2.44%)  0/42 (0.00%)  0/44 (0.00%)  0/45 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo QD Alogliptin 6.25 mg QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Alogliptin 50 mg QD Alogliptin 100 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/41 (34.15%)   12/42 (28.57%)   18/44 (40.91%)   19/45 (42.22%)   15/43 (34.88%)   22/44 (50.00%) 
Eye disorders             
Vision blurred  1  0/41 (0.00%)  1/42 (2.38%)  1/44 (2.27%)  2/45 (4.44%)  0/43 (0.00%)  0/44 (0.00%) 
Gastrointestinal disorders             
Abdominal pain  1  0/41 (0.00%)  0/42 (0.00%)  2/44 (4.55%)  1/45 (2.22%)  0/43 (0.00%)  0/44 (0.00%) 
Abdominal pain upper  1  0/41 (0.00%)  2/42 (4.76%)  1/44 (2.27%)  3/45 (6.67%)  0/43 (0.00%)  0/44 (0.00%) 
Constipation  1  1/41 (2.44%)  0/42 (0.00%)  2/44 (4.55%)  0/45 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Diarrhoea  1  3/41 (7.32%)  0/42 (0.00%)  1/44 (2.27%)  1/45 (2.22%)  3/43 (6.98%)  0/44 (0.00%) 
Nausea  1  0/41 (0.00%)  2/42 (4.76%)  1/44 (2.27%)  1/45 (2.22%)  2/43 (4.65%)  5/44 (11.36%) 
General disorders             
Fatigue  1  2/41 (4.88%)  0/42 (0.00%)  1/44 (2.27%)  0/45 (0.00%)  2/43 (4.65%)  3/44 (6.82%) 
Oedema peripheral  1  1/41 (2.44%)  1/42 (2.38%)  1/44 (2.27%)  0/45 (0.00%)  1/43 (2.33%)  2/44 (4.55%) 
Infections and infestations             
Fungal infection  1  2/41 (4.88%)  0/42 (0.00%)  0/44 (0.00%)  0/45 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Gastroenteritis  1  1/41 (2.44%)  0/42 (0.00%)  0/44 (0.00%)  2/45 (4.44%)  0/43 (0.00%)  0/44 (0.00%) 
Gastroenteritis viral  1  0/41 (0.00%)  0/42 (0.00%)  2/44 (4.55%)  0/45 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Nasopharyngitis  1  2/41 (4.88%)  0/42 (0.00%)  2/44 (4.55%)  2/45 (4.44%)  1/43 (2.33%)  1/44 (2.27%) 
Upper respiratory tract infection  1  0/41 (0.00%)  1/42 (2.38%)  0/44 (0.00%)  2/45 (4.44%)  1/43 (2.33%)  1/44 (2.27%) 
Urinary tract infection  1  4/41 (9.76%)  3/42 (7.14%)  1/44 (2.27%)  3/45 (6.67%)  3/43 (6.98%)  4/44 (9.09%) 
Investigations             
Weight decreased  1  0/41 (0.00%)  0/42 (0.00%)  1/44 (2.27%)  2/45 (4.44%)  0/43 (0.00%)  1/44 (2.27%) 
Metabolism and nutrition disorders             
Hyperglycaemia  1  0/41 (0.00%)  0/42 (0.00%)  2/44 (4.55%)  0/45 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/41 (0.00%)  1/42 (2.38%)  2/44 (4.55%)  0/45 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Back pain  1  1/41 (2.44%)  1/42 (2.38%)  0/44 (0.00%)  1/45 (2.22%)  2/43 (4.65%)  1/44 (2.27%) 
Myalgia  1  0/41 (0.00%)  1/42 (2.38%)  1/44 (2.27%)  0/45 (0.00%)  0/43 (0.00%)  3/44 (6.82%) 
Neck pain  1  0/41 (0.00%)  0/42 (0.00%)  2/44 (4.55%)  0/45 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Pain in extremity  1  0/41 (0.00%)  1/42 (2.38%)  1/44 (2.27%)  3/45 (6.67%)  0/43 (0.00%)  2/44 (4.55%) 
Nervous system disorders             
Dizziness  1  0/41 (0.00%)  2/42 (4.76%)  0/44 (0.00%)  3/45 (6.67%)  1/43 (2.33%)  1/44 (2.27%) 
Headache  1  3/41 (7.32%)  2/42 (4.76%)  0/44 (0.00%)  4/45 (8.89%)  3/43 (6.98%)  4/44 (9.09%) 
Paraesthesia  1  0/41 (0.00%)  0/42 (0.00%)  2/44 (4.55%)  0/45 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Somnolence  1  0/41 (0.00%)  0/42 (0.00%)  0/44 (0.00%)  2/45 (4.44%)  0/43 (0.00%)  0/44 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  1/41 (2.44%)  0/42 (0.00%)  1/44 (2.27%)  0/45 (0.00%)  0/43 (0.00%)  2/44 (4.55%) 
Pharyngolaryngeal pain  1  0/41 (0.00%)  0/42 (0.00%)  0/44 (0.00%)  2/45 (4.44%)  0/43 (0.00%)  2/44 (4.55%) 
Skin and subcutaneous tissue disorders             
Rash  1  1/41 (2.44%)  0/42 (0.00%)  4/44 (9.09%)  0/45 (0.00%)  1/43 (2.33%)  1/44 (2.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.1
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.
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: NCT00755846     History of Changes
Other Study ID Numbers: SYR-322-003
U1111-1113-8352 ( Registry Identifier: WHO )
First Submitted: September 17, 2008
First Posted: September 19, 2008
Results First Submitted: June 8, 2011
Results First Posted: August 29, 2011
Last Update Posted: February 3, 2012