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Efficacy and Safety of Alogliptin in Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00286455
Recruitment Status : Completed
First Posted : February 3, 2006
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 329

Recruitment Details Participants enrolled at 117 investigative sites in 16 countries from 24 February 2006 to 05 July 2007.
Pre-assignment Details Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in one of 3, once-daily (QD) treatment groups.
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Period Title: Overall Study
Started 65 133 131
Completed 40 105 107
Not Completed 25 28 24
Reason Not Completed
Hyperglycemia rescue             19             13             10
Adverse Event             1             3             2
Lost to Follow-up             0             3             3
Physician Decision             3             0             2
Protocol Violation             1             1             0
Participant Non-compliance             1             0             0
Withdrawal by Subject             0             8             7
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD Total
Hide Arm/Group Description Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks. Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks. Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks. Total of all reporting groups
Overall Number of Baseline Participants 65 133 131 329
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 133 participants 131 participants 329 participants
<65 years 53 110 111 274
Between 65 and 74 years 8 18 16 42
≥75 years 4 5 4 13
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 133 participants 131 participants 329 participants
Female
32
  49.2%
68
  51.1%
54
  41.2%
154
  46.8%
Male
33
  50.8%
65
  48.9%
77
  58.8%
175
  53.2%
1.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.
Hide Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.
Time Frame Baseline and Week 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at the week 26 visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 63 131 128
Least Squares Mean (Standard Error)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.02  (0.094) -0.56  (0.065) -0.59  (0.066)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided >0.05 significance level and >=80% of subjects meeting per protocol criteria.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-0.76 to -0.31
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 25 mg QD
Comments Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided >0.05 significance level and >=80% of subjects meeting per protocol criteria.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-0.80 to -0.35
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.
2.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 4).
Hide Description The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.
Time Frame Baseline and Week 4.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 59 123 120
Least Squares Mean (Standard Error)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.11  (0.052) -0.37  (0.035) -0.45  (0.036)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-0.39 to -0.14
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 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.46 to -0.21
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 Glycosylated Hemoglobin (Week 8).
Hide Description The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.
Time Frame Baseline and Week 8.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 63 131 128
Least Squares Mean (Standard Error)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.13  (0.072) -0.53  (0.049) -0.64  (0.050)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.57 to -0.23
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.51
Confidence Interval (2-Sided) 95%
-0.68 to -0.33
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.
4.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 12).
Hide Description The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.
Time Frame Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 63 131 128
Least Squares Mean (Standard Error)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.13  (0.080) -0.57  (0.055) -0.66  (0.056)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-0.63 to -0.25
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-0.73 to -0.35
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.
5.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 16).
Hide Description The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.
Time Frame Baseline and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 63 131 128
Least Squares Mean (Standard Error)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.12  (0.085) -0.59  (0.058) -0.65  (0.059)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.68 to -0.27
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 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-0.74 to -0.33
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.
6.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (Week 20).
Hide Description The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.
Time Frame Baseline and Week 20.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 63 131 128
Least Squares Mean (Standard Error)
Unit of Measure: percentage of Glycosylated Hemoglobin
-0.12  (0.090) -0.58  (0.062) -0.61  (0.062)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.67 to -0.24
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-0.70 to -0.27
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.
7.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 1).
Hide Description The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.
Time Frame Baseline and Week 1.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 60 120 121
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
4.6  (3.45) -8.6  (2.41) -14.0  (2.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.2
Confidence Interval (2-Sided) 95%
-21.5 to -5.0
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.7
Confidence Interval (2-Sided) 95%
-27.0 to -10.4
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 Fasting Plasma Glucose (Week 2).
Hide Description The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.
Time Frame Baseline and Week 2.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 62 129 126
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
3.8  (3.47) -14.6  (2.38) -17.6  (2.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.4
Confidence Interval (2-Sided) 95%
-26.7 to -10.1
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -21.4
Confidence Interval (2-Sided) 95%
-29.7 to -13.0
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 Fasting Plasma Glucose (Week 4).
Hide Description The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.
Time Frame Baseline and Week 4.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 64 131 129
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
2.8  (3.63) -15.6  (2.51) -21.6  (2.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.4
Confidence Interval (2-Sided) 95%
-27.1 to -9.7
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.4
Confidence Interval (2-Sided) 95%
-33.2 to -15.7
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.
10.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 8).
Hide Description The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
Time Frame Baseline and Week 8.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 64 131 129
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
2.5  (4.20) -14.3  (2.91) -19.8  (2.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.7
Confidence Interval (2-Sided) 95%
-26.8 to -6.7
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.3
Confidence Interval (2-Sided) 95%
-32.4 to -12.2
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.
11.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (Week 12).
Hide Description The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
Time Frame Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 64 132 129
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
1.2  (4.29) -15.3  (2.97) -20.0  (3.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.5
Confidence Interval (2-Sided) 95%
-26.8 to -6.2
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -21.2
Confidence Interval (2-Sided) 95%
-31.6 to -10.8
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 Fasting Plasma Glucose (Week 16).
Hide Description The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
Time Frame Baseline and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 64 132 129
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
5.2  (4.64) -14.6  (3.21) -18.2  (3.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.8
Confidence Interval (2-Sided) 95%
-30.9 to -8.7
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.4
Confidence Interval (2-Sided) 95%
-34.6 to -12.2
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 Fasting Plasma Glucose (Week 20).
Hide Description The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
Time Frame Baseline and Week 20.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 64 132 129
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
7.0  (4.73) -12.3  (3.27) -17.3  (3.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.3
Confidence Interval (2-Sided) 95%
-30.6 to -8.0
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.3
Confidence Interval (2-Sided) 95%
-35.7 to -12.9
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 Fasting Plasma Glucose (Week 26).
Hide Description The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.
Time Frame Baseline and Week 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 64 132 131
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
11.3  (5.24) -10.3  (3.62) -16.4  (3.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -21.6
Confidence Interval (2-Sided) 95%
-34.1 to -9.0
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -27.8
Confidence Interval (2-Sided) 95%
-40.4 to -15.1
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 Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).
Hide Description The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL at any measurement time point during the 26 week study.
Time Frame 26 Weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set)and had at least 1 post-baseline FPG measurement.
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 64 133 130
Measure Type: Number
Unit of Measure: participants
30 44 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.165
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.569
Confidence Interval (2-Sided) 95%
0.257 to 1.262
Estimation Comments Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.320
Confidence Interval (2-Sided) 95%
0.138 to 0.739
Estimation Comments Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.
16.Secondary Outcome
Title Number of Participants Requiring Rescue.
Hide Description The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.
Time Frame 26 Weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 64 133 131
Measure Type: Number
Unit of Measure: participants
19 13 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.194
Confidence Interval (2-Sided) 95%
0.073 to 0.516
Estimation Comments Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.145
Confidence Interval (2-Sided) 95%
0.052 to 0.405
Estimation Comments Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.
17.Secondary Outcome
Title Change From Baseline in Fasting Proinsulin (Week 4).
Hide Description The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.
Time Frame Baseline and Week 4.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 57 118 117
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
2.9  (3.24) -4.7  (2.22) -10.4  (2.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.6
Confidence Interval (2-Sided) 95%
-15.3 to 0.2
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.3
Confidence Interval (2-Sided) 95%
-21.1 to -5.5
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.
18.Secondary Outcome
Title Change From Baseline in Fasting Proinsulin (Week 8).
Hide Description The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.
Time Frame Baseline and Week 8.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 61 128 124
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-3.9  (3.60) -3.1  (2.46) -1.4  (2.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.850
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-7.8 to 9.4
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 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.571
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-6.2 to 11.2
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.
19.Secondary Outcome
Title Change From Baseline in Fasting Proinsulin (Week 12).
Hide Description The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.
Time Frame Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 61 129 124
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-2.8  (3.10) -3.2  (2.11) -8.5  (2.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.917
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-7.8 to 7.0
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 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.7
Confidence Interval (2-Sided) 95%
-13.2 to 1.7
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.
20.Secondary Outcome
Title Change From Baseline in Fasting Proinsulin (Week 16).
Hide Description The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.
Time Frame Baseline and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 61 129 124
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-0.6  (3.42) -4.5  (2.33) -6.6  (2.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-12.1 to 4.3
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 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.152
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.0
Confidence Interval (2-Sided) 95%
-14.3 to 2.2
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.
21.Secondary Outcome
Title Change From Baseline in Fasting Proinsulin (Week 20).
Hide Description The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.
Time Frame Baseline and Week 20.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 61 129 124
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-0.8  (2.75) -6.0  (1.87) -6.3  (1.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.2
Confidence Interval (2-Sided) 95%
-11.7 to 1.4
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 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.104
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.5
Confidence Interval (2-Sided) 95%
-12.1 to 1.1
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.
22.Secondary Outcome
Title Change From Baseline in Fasting Proinsulin (Week 26).
Hide Description The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.
Time Frame Baseline and Week 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 61 129 124
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-2.1  (2.87) -6.1  (1.96) -7.4  (2.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.247
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.0
Confidence Interval (2-Sided) 95%
-10.9 to 2.8
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 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.129
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.4
Confidence Interval (2-Sided) 95%
-12.3 to 1.6
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.
23.Secondary Outcome
Title Change From Baseline in Insulin (Week 4).
Hide Description The change between the value of insulin collected at week 4 and insulin collected at baseline.
Time Frame Baseline and Week 4.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 55 118 117
Least Squares Mean (Standard Error)
Unit of Measure: ϻIU/mL
0.87  (1.430) 0.14  (0.965) -1.27  (0.973)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.671
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.73
Confidence Interval (2-Sided) 95%
-4.14 to 2.67
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 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.15
Confidence Interval (2-Sided) 95%
-5.57 to 1.27
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.
24.Secondary Outcome
Title Change From Baseline in Insulin (Week 8).
Hide Description The change between the value of insulin collected at week 8 and insulin collected at baseline.
Time Frame Baseline and Week 8.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 59 128 124
Least Squares Mean (Standard Error)
Unit of Measure: ϻIU/mL
-0.35  (1.520) 1.18  (1.023) 0.94  (1.042)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.403
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
-2.07 to 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 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.487
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
-2.35 to 4.93
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.
25.Secondary Outcome
Title Change From Baseline in Insulin (Week 12).
Hide Description The change between the value of insulin collected at week 12 and insulin collected at baseline.
Time Frame Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 59 129 124
Least Squares Mean (Standard Error)
Unit of Measure: ϻIU/mL
-1.66  (1.467) 0.94  (0.984) -1.60  (1.006)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.60
Confidence Interval (2-Sided) 95%
-0.88 to 6.08
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 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.974
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-3.46 to 3.57
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.
26.Secondary Outcome
Title Change From Baseline in Insulin (Week 16).
Hide Description The change between the value of insulin collected at week 16 and insulin collected at baseline.
Time Frame Baseline and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 59 129 124
Least Squares Mean (Standard Error)
Unit of Measure: ϻIU/mL
-0.41  (1.577) 0.55  (1.058) -1.46  (1.082)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.612
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
-2.78 to 4.71
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 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.587
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.04
Confidence Interval (2-Sided) 95%
-4.82 to 2.74
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.
27.Secondary Outcome
Title Change From Baseline in Insulin (Week 20).
Hide Description The change between the value of insulin collected at week 20 and insulin collected at baseline.
Time Frame Baseline and Week 20.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 59 129 124
Least Squares Mean (Standard Error)
Unit of Measure: ϻIU/mL
-1.32  (1.264) -0.32  (0.847) -1.12  (0.867)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.514
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
-2.00 to 3.99
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 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.899
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-2.83 to 3.22
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.
28.Secondary Outcome
Title Change From Baseline in Insulin (Week 26).
Hide Description The change between the value of insulin collected at week 26 and insulin collected at baseline.
Time Frame Baseline and Week 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 59 129 124
Least Squares Mean (Standard Error)
Unit of Measure: ϻIU/mL
-1.17  (1.404) -0.92  (0.942) -1.08  (0.963)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.885
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-3.09 to 3.58
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 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.958
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-3.28 to 3.46
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.
29.Secondary Outcome
Title Change From Baseline in Proinsulin/Insulin Ratio (Week 4).
Hide Description The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.
Time Frame Baseline and Week 4.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 55 118 117
Least Squares Mean (Standard Error)
Unit of Measure: ratio
0.008  (0.0140) -0.043  (0.0094) -0.063  (0.0095)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.051
Confidence Interval (2-Sided) 95%
-0.084 to -0.018
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.072
Confidence Interval (2-Sided) 95%
-0.105 to -0.038
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.
30.Secondary Outcome
Title Change From Baseline in Proinsulin/Insulin Ratio (Week 8).
Hide Description The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.
Time Frame Baseline and Week 8.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 59 128 124
Least Squares Mean (Standard Error)
Unit of Measure: ratio
0.014  (0.0130) -0.054  (0.0087) -0.038  (0.0089)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.069
Confidence Interval (2-Sided) 95%
-0.099 to -0.038
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.052
Confidence Interval (2-Sided) 95%
-0.083 to -0.021
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.
31.Secondary Outcome
Title Change From Baseline in Proinsulin/Insulin Ratio (Week 12).
Hide Description The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.
Time Frame Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 59 129 124
Least Squares Mean (Standard Error)
Unit of Measure: ratio
0.025  (0.0150) -0.043  (0.0100) -0.047  (0.0103)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.068
Confidence Interval (2-Sided) 95%
-0.103 to -0.032
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.073
Confidence Interval (2-Sided) 95%
-0.109 to -0.037
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.
32.Secondary Outcome
Title Change From Baseline in Proinsulin/Insulin Ratio (Week 16).
Hide Description The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.
Time Frame Baseline and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 59 129 124
Least Squares Mean (Standard Error)
Unit of Measure: ratio
0.001  (0.0162) -0.044  (0.0109) -0.039  (0.0111)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.045
Confidence Interval (2-Sided) 95%
-0.084 to -0.007
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 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.040
Confidence Interval (2-Sided) 95%
-0.079 to -0.001
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.
33.Secondary Outcome
Title Change From Baseline in Proinsulin/Insulin Ratio (Week 20).
Hide Description The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.
Time Frame Baseline and Week 20.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 59 129 124
Least Squares Mean (Standard Error)
Unit of Measure: ratio
0.119  (0.0393) -0.043  (0.0263) -0.040  (0.0270)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.162
Confidence Interval (2-Sided) 95%
-0.255 to -0.069
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.159
Confidence Interval (2-Sided) 95%
-0.254 to -0.065
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.
34.Secondary Outcome
Title Change From Baseline in Proinsulin/Insulin Ratio (Week 26).
Hide Description The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.
Time Frame Baseline and Week 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 59 129 124
Least Squares Mean (Standard Error)
Unit of Measure: ratio
0.046  (0.0219) -0.040  (0.0147) -0.038  (0.0150)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.086
Confidence Interval (2-Sided) 95%
-0.138 to -0.034
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.084
Confidence Interval (2-Sided) 95%
-0.137 to -0.032
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.
35.Secondary Outcome
Title Change From Baseline in C-peptide (Week 4).
Hide Description The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.
Time Frame Baseline and Week 4.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 59 119 120
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
0.242  (0.1467) 0.026  (0.1024) 0.088  (0.1023)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.230
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.216
Confidence Interval (2-Sided) 95%
-0.568 to 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 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.393
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.154
Confidence Interval (2-Sided) 95%
-0.508 to 0.200
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.
36.Secondary Outcome
Title Change From Baseline in C-peptide (Week 8).
Hide Description The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.
Time Frame Baseline and Week 8.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 63 129 127
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
-0.014  (0.1801) 0.070  (0.1249) 0.269  (0.1263)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.703
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.084
Confidence Interval (2-Sided) 95%
-0.348 to 0.515
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 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.203
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.282
Confidence Interval (2-Sided) 95%
-0.153 to 0.717
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.
37.Secondary Outcome
Title Change From Baseline in C-peptide (Week 12).
Hide Description The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.
Time Frame Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 63 130 127
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
-0.104  (0.1673) 0.064  (0.1156) -0.091  (0.1173)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.408
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.169
Confidence Interval (2-Sided) 95%
-0.232 to 0.569
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 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.949
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.013
Confidence Interval (2-Sided) 95%
-0.391 to 0.417
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.
38.Secondary Outcome
Title Change From Baseline in C-peptide (Week 16).
Hide Description The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.
Time Frame Baseline and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 63 130 127
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
-0.030  (0.1712) -0.060  (0.1183) -0.127  (0.1200)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.886
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.030
Confidence Interval (2-Sided) 95%
-0.440 to 0.380
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 25 mg QD
Comments [Not Specified]
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 geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.097
Confidence Interval (2-Sided) 95%
-0.510 to 0.317
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.
39.Secondary Outcome
Title Change From Baseline in C-peptide (Week 20).
Hide Description The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.
Time Frame Baseline and Week 20.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 63 130 127
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
-0.194  (0.1288) -0.264  (0.0890) -0.231  (0.0903)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.656
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.070
Confidence Interval (2-Sided) 95%
-0.378 to 0.239
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 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.819
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.036
Confidence Interval (2-Sided) 95%
-0.347 to 0.275
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.
40.Secondary Outcome
Title Change From Baseline in C-peptide (Week 26).
Hide Description The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.
Time Frame Baseline and Week 26.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo QD Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Overall Number of Participants Analyzed 63 130 127
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
-0.282  (0.1387) -0.360  (0.0958) -0.279  (0.0973)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of