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Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.

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ClinicalTrials.gov Identifier: NCT00286468
Recruitment Status : Completed
First Posted : February 3, 2006
Results First Posted : August 25, 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 and glyburide
Drug: Glyburide
Enrollment 500
Recruitment Details Participants enrolled at 125 investigative sites in Argentina, Australia, Brazil, Chile, Dominican Republic, Germany, Guatemala, India, Mexico, New Zealand, The Netherlands, Poland, South Africa, Spain, and the United States from 04 April 2006 to 20 June 2007.
Pre-assignment Details Participants with a historical diagnosis of type 2 diabetes mellitus who were inadequately controlled while receiving a stable dose of glyburide monotherapy were enrolled in one of 3, once-daily (QD) treatment groups.
Arm/Group Title Placebo Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks. Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks. Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Period Title: Overall Study
Started 99 203 198
Completed 62 153 148
Not Completed 37 50 50
Reason Not Completed
Hyperglycemic Rescue             28             30             31
Adverse Event             2             6             4
Protocol Violation             0             3             1
Lost to Follow-up             1             1             2
Withdrawal by Subject             3             8             11
Physician Decision             3             2             1
Arm/Group Title Placebo Alogliptin 12.5 mg QD Alogliptin 25 mg QD Total
Hide Arm/Group Description Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks. Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks. Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks. Total of all reporting groups
Overall Number of Baseline Participants 99 203 198 500
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 203 participants 198 participants 500 participants
<65 years 72 153 145 370
Between 65 and 74 years 23 42 47 112
≥75 years 4 8 6 18
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 203 participants 198 participants 500 participants
Female
48
  48.5%
92
  45.3%
99
  50.0%
239
  47.8%
Male
51
  51.5%
111
  54.7%
99
  50.0%
261
  52.2%
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 visit. Missing data are imputed using last observation carried forward (LOCF).
Arm/Group Title Placebo Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 201 197 97
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
0.01  (0.084) -0.38  (0.058) -0.52  (0.058)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=500 subjects had 94% power to detect a treatment difference as small as 0.4% 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; baseline glyburide dose and baseline value for glycosylated hemoglobin as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.59 to -0.19
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, Alogliptin 25 mg QD
Comments Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=500 subjects had 94% power to detect a treatment difference as small as 0.4% 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-0.73 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.
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 week 4 due to unavailable prior value to carry forward.
Arm/Group Title Placebo Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 89 191 186
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-0.18  (0.042) -0.40  (0.028) -0.46  (0.029)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.33 to -0.13
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.38 to -0.18
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 97 201 197
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-0.18  (0.057) -0.57  (0.040) -0.65  (0.040)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.53 to -0.26
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 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; baseline glyburide dose 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%
-0.61 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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 97 201 197
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-0.17  (0.068) -0.58  (0.047) -0.69  (0.047)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.57 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, 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-0.68 to -0.36
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 97 201 197
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-0.16  (0.072) -0.53  (0.050) -0.66  (0.051)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.54 to -0.19
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, 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 97 201 197
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-0.08  (0.077) -0.43  (0.053) -0.60  (0.054)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.54 to -0.17
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-0.71 to -0.34
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 91 189 185
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
0.3  (3.62) -11.8  (2.51) -19.0  (2.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.1
Confidence Interval (2-Sided) 95%
-20.8 to -3.4
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, 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; baseline glyburide dose 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%
-28.0 to -10.6
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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 95 197 194
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-1.8  (3.20) -16.7  (2.21) -21.8  (2.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.9
Confidence Interval (2-Sided) 95%
-22.5 to -7.2
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, 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.0
Confidence Interval (2-Sided) 95%
-27.7 to -12.4
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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 97 198 197
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-3.7  (3.48) -14.6  (2.42) -21.1  (2.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.9
Confidence Interval (2-Sided) 95%
-19.3 to -2.6
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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.4
Confidence Interval (2-Sided) 95%
-25.8 to -9.1
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.
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).
Arm/Group Title Placebo Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 97 200 198
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-3.2  (3.55) -19.9  (2.46) -18.6  (2.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 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; baseline glyburide dose 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%
-25.2 to -8.2
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, 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; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.4
Confidence Interval (2-Sided) 95%
-23.9 to -6.9
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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 98 201 198
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-3.4  (3.79) -13.5  (2.64) -15.0  (2.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.1
Confidence Interval (2-Sided) 95%
-19.2 to -1.0
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.7
Confidence Interval (2-Sided) 95%
-20.8 to -2.5
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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 99 201 198
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-7.1  (4.03) -9.0  (2.81) -13.0  (2.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.701
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-11.6 to 7.8
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.228
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose 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%
-15.7 to 3.7
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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 99 201 198
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-0.4  (4.41) -9.3  (3.08) -13.6  (3.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.097
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.0
Confidence Interval (2-Sided) 95%
-19.6 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose 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%
-23.9 to -2.7
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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 99 201 198
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
2.2  (4.77) -4.7  (3.33) -8.4  (3.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.241
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.8
Confidence Interval (2-Sided) 95%
-18.3 to 4.6
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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.5
Confidence Interval (2-Sided) 95%
-22.0 to 0.9
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.
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 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 have at least 1 post-baseline measurement for fasting plasma glucose.
Arm/Group Title Placebo Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 99 200 198
Measure Type: Number
Unit of Measure: participants
53 94 79
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.338
Comments no multiplicity adjustments
Method Regression, Logistic
Comments Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.775
Confidence Interval (2-Sided) 95%
0.460 to 1.306
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments no multiplicity adjustments
Method Regression, Logistic
Comments Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.521
Confidence Interval (2-Sided) 95%
0.306 to 0.887
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 99 201 198
Measure Type: Number
Unit of Measure: participants
28 30 31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 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 Regression, Logistic
Comments Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.374
Confidence Interval (2-Sided) 95%
0.194 to 0.720
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, Alogliptin 25 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 Regression, Logistic
Comments Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.372
Confidence Interval (2-Sided) 95%
0.193 to 0.718
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 85 178 178
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-3.0  (2.68) -2.6  (1.84) 0.7  (1.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.923
Comments No multiplicity adjustments.
Method Regression, Logistic
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-6.1 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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.259
Comments No multiplicity adjustments.
Method Regression, Logistic
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.7
Confidence Interval (2-Sided) 95%
-2.7 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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 91 187 188
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-4.2  (2.61) -4.5  (1.81) -0.9  (1.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.916
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-6.6 to 5.9
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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.305
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
-3.0 to 9.5
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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 91 188 188
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-0.5  (2.49) -0.7  (1.73) -0.7  (1.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.953
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-6.1 to 5.8
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.957
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-6.1 to 5.8
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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 91 188 188
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-1.8  (2.61) -1.5  (1.81) -1.1  (1.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.908
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose 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%
-5.9 to 6.6
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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.826
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-5.6 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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 91 188 188
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-2.5  (2.65) -2.1  (1.84) 0.0  (1.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.894
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose 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%
-5.9 to 6.8
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.432
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose 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%
-3.8 to 8.9
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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 91 188 188
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-2.0  (2.60) -3.9  (1.81) -2.1  (1.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.548
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-8.1 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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.986
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-6.3 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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 83 173 174
Least Squares Mean (Standard Error)
Unit of Measure: mcIU/mL
-0.62  (1.273) 0.64  (0.879) 0.89  (0.877)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.415
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
-1.78 to 4.30
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.332
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
-1.54 to 4.55
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 89 185 185
Least Squares Mean (Standard Error)
Unit of Measure: mcIU/mL
-0.81  (1.114) -0.62  (0.770) 0.38  (0.771)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.890
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-2.47 to 2.85
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.380
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
-1.48 to 3.86
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 89 186 186
Least Squares Mean (Standard Error)
Unit of Measure: mcIU/mL
-0.02  (1.464) 1.33  (1.009) 1.00  (1.010)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
-2.14 to 4.85
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.568
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
-2.48 to 4.52
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 89 186 186
Least Squares Mean (Standard Error)
Unit of Measure: mcIU/mL
-1.21  (1.368) 1.74  (0.943) 0.51  (0.944)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.95
Confidence Interval (2-Sided) 95%
-0.32 to 6.22
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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.303
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.72
Confidence Interval (2-Sided) 95%
-1.55 to 4.99
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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 89 186 186
Least Squares Mean (Standard Error)
Unit of Measure: mcIU/mL
-0.07  (1.393) 1.18  (0.960) 0.93  (0.962)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.461
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
-2.08 to 4.57
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.559
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
-2.34 to 4.32
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 89 186 186
Least Squares Mean (Standard Error)
Unit of Measure: mcIU/mL
-1.89  (1.081) -0.85  (0.745) 0.14  (0.746)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.430
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose 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%
-1.54 to 3.62
Estimation Comments Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.03
Confidence Interval (2-Sided) 95%
-0.56 to 4.61
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 83 172 174
Least Squares Mean (Standard Error)
Unit of Measure: ratio
-0.008  (0.0180) -0.064  (0.0125) -0.043  (0.0124)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.056
Confidence Interval (2-Sided) 95%
-0.099 to -0.013
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.116
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.035
Confidence Interval (2-Sided) 95%
-0.078 to 0.009
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 89 184 185
Least Squares Mean (Standard Error)
Unit of Measure: ratio
-0.009  (0.0158) -0.052  (0.0110) -0.045  (0.0109)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.044
Confidence Interval (2-Sided) 95%
-0.081 to -0.006
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.037
Confidence Interval (2-Sided) 95%
-0.074 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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 89 185 186
Least Squares Mean (Standard Error)
Unit of Measure: ratio
-0.002  (0.0163) -0.030  (0.0113) -0.040  (0.0113)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.028
Confidence Interval (2-Sided) 95%
-0.067 to 0.011
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.038
Confidence Interval (2-Sided) 95%
-0.077 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.
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 89 185 186
Least Squares Mean (Standard Error)
Unit of Measure: ratio
0.003  (0.0172) -0.037  (0.0119) -0.041  (0.0119)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.039
Confidence Interval (2-Sided) 95%
-0.080 to 0.002
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.043
Confidence Interval (2-Sided) 95%
-0.084 to -0.002
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 89 185 186
Least Squares Mean (Standard Error)
Unit of Measure: ratio
-0.005  (0.0167) -0.035  (0.0116) -0.036  (0.0115)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.148
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose 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%
-0.069 to 0.010
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.135
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.031
Confidence Interval (2-Sided) 95%
-0.071 to 0.009
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 89 185 186
Least Squares Mean (Standard Error)
Unit of Measure: ratio
-0.008  (0.0161) -0.034  (0.0111) -0.034  (0.0111)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.026
Confidence Interval (2-Sided) 95%
-0.065 to 0.012
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.026
Confidence Interval (2-Sided) 95%
-0.065 to 0.012
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 87 183 184
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
-0.041  (0.1355) 0.122  (0.0932) 0.136  (0.0930)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.324
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose 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%
-0.161 to 0.486
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.284
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.176
Confidence Interval (2-Sided) 95%
-0.147 to 0.500
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 94 196 196
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
-0.176  (0.1138) 0.092  (0.0786) 0.173  (0.0785)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.268
Confidence Interval (2-Sided) 95%
-0.004 to 0.540
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.349
Confidence Interval (2-Sided) 95%
0.077 to 0.621
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 95 198 196
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
-0.020  (0.1155) 0.162  (0.0797) 0.206  (0.0801)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.196
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.182
Confidence Interval (2-Sided) 95%
-0.094 to 0.458
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.226
Confidence Interval (2-Sided) 95%
-0.051 to 0.502
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 96 198 196
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
-0.007  (0.1206) 0.222  (0.0837) 0.153  (0.0841)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.121
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.228
Confidence Interval (2-Sided) 95%
-0.060 to 0.517
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.280
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose 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%
-0.130 to 0.448
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 96 198 196
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
-0.016  (0.1275) -0.001  (0.0884) 0.122  (0.0889)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alogliptin 12.5 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.924
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.015
Confidence Interval (2-Sided) 95%
-0.290 to 0.320
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, Alogliptin 25 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.376
Comments No multiplicity adjustments.
Method ANCOVA
Comments Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.138
Confidence Interval (2-Sided) 95%
-0.168 to 0.444
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 Alogliptin 12.5 mg QD Alogliptin 25 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Overall Number of Participants Analyzed 96 198 196
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
-0.215  (0.1326) -0.140  (0.0920) -0.153  (0.0925)
Show Statistical Analysis 1