Efficacy and Safety Study of Alogliptin and Insulin in th... | NCT00286429

ID	Type	Description	Link
2005-004671-38	EudraCT Number
U1111-1113-8369	Registry Identifier	WHO

Label	Type	Intervention Names
Insulin	Placebo Comparator	Drug: Insulin
Alogliptin 12.5 mg QD	Experimental	Drug: Alogliptin and insulin
Alogliptin 25 mg QD	Experimental	Drug: Alogliptin and insulin

Name	Type	Description	Arm Group Labels	Other Names
Alogliptin and insulin	Drug	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.	Alogliptin 12.5 mg QD

Measure	Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.	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.	Baseline and Week 26.

Measure	Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin (Week 4).	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.	Baseline and Week 4.

Name	Affiliation	Role
VP Biological Sciences	Takeda	Study Director

PubMed Identifier	Type	Citation	Retractions
19758359	Result	Rosenstock J, Rendell MS, Gross JL, Fleck PR, Wilson CA, Mekki Q. Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA(1C) without causing weight gain or increased hypoglycaemia. Diabetes Obes Metab. 2009 Dec;11(12):1145-52. doi: 10.1111/j.1463-1326.2009.01124.x. Epub 2009 Sep 16.
19793357	Result

ID	Title	Description
FG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
FG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Primary

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.

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.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF). ANCOVA = Analysis of covariance.

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants	OG000126 OG001130 OG002126

Title

Denominators

Categories

Title	Measurements
	OG000-0.13± 0.077 OG001-0.63± 0.076 OG002-0.71± 0.078

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 26. For comparison of either alogliptin dose vs. placebo (2-sample t test), study sample size >=390 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming a standard deviation of 0.8%, a 2-sided test at 0.05 significance level and >=80% of subjects meeting the per protocol criteria.	ANCOVA	ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).	<0.001	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.	Mean Difference (Final Values)	-0.51			2-Sided	95	-0.72

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 4).

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.

Randomized participants who received at least 1 dose of study drug and who had an HbA1c measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 4.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 8).

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.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 8.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 12).

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.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 12.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 16).

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.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 16.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 20).

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.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 20.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Secondary

Change From Baseline in Fasting Plasma Glucose (Week 1).

The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 1. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 1.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting Plasma Glucose (Week 2).

The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 2. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 2.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting Plasma Glucose (Week 4).

The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 4.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting Plasma Glucose (Week 8).

The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 8.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting Plasma Glucose (Week 12).

The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 12.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting Plasma Glucose (Week 16).

The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 16.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting Plasma Glucose (Week 20).

The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 20.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting Plasma Glucose (Week 26).

The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).

The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 fasting plasma glucose measurement after baseline.

Posted

Number

participants

26 Weeks.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Number of Participants Requiring Rescue.

The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 study visit after baseline.

Posted

Number

participants

26 Weeks.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in C-peptide (Week 4).

The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 4.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in C-peptide (Week 8).

The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 8.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in C-peptide (Week 12).

The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 12.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in C-peptide (Week 16).

The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 16.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in C-peptide (Week 20).

The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 20.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in C-peptide (Week 26).

The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 HbA1c measurement after baseline.

Due to no participants in the placebo arm achieved HbA1c ≤ 6.5%, the odds ratio of alogliptin to placebo and 95% CI were not estimable from the logistic regression.

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Secondary

Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.

Due to no participants in the placebo arm achieved HbA1c decrease from baseline ≥2.0%, the odds ratio of alogliptin to placebo and 95% CI were not estimable from the logistic regression.

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Secondary

Change From Baseline in Body Weight (Week 8).

The change between Body Weight measured at week 8 and Body Weight measured at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

kg

Baseline and Week 8.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Body Weight (Week 12).

The change between Body Weight measured at week 12 and Body Weight measured at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

kg

Baseline and Week 12.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Body Weight (Week 20).

The change between Body Weight measured at week 20 and Body Weight measured at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

kg

Baseline and Week 20.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Body Weight (Week 26).

The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.

Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

kg

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Units	Counts
Participants

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona		United States

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.	6	129	54	129
EG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.	8	131	58	131
EG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.	7	129	50	129

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected129 at risk EG0010 affected131 at risk EG0021 affected129 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0010 affected131 at risk EG0021 affected129 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0012 affected131 at risk EG0020 affected129 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected129 at risk EG0010 affected131 at risk EG0020 affected129 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0012 affected131 at risk EG0020 affected129 at risk
Coronary artery disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0011 affected131 at risk EG0020 affected129 at risk
Demyelination	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected129 at risk EG0010 affected131 at risk EG0020 affected129 at risk
Diverticulitis intestinal haemorrhagic	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected129 at risk EG0010 affected131 at risk EG0020 affected129 at risk
Hypersensitivity	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0010 affected131 at risk EG0021 affected129 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0010 affected131 at risk EG0021 affected129 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected129 at risk EG0010 affected131 at risk EG0020 affected129 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected129 at risk EG0010 affected131 at risk EG0020 affected129 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0011 affected131 at risk EG0020 affected129 at risk
Pyelonephritis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0010 affected131 at risk EG0021 affected129 at risk
Sciatica	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0011 affected131 at risk EG0020 affected129 at risk
Scrotal abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0011 affected131 at risk EG0020 affected129 at risk
Staphylococcal infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0010 affected131 at risk EG0021 affected129 at risk
Sudden death	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0011 affected131 at risk EG0020 affected129 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0010 affected131 at risk EG0021 affected129 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected129 at risk EG0011 affected131 at risk EG0026 affected129 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected129 at risk EG0019 affected131 at risk EG0023 affected129 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected129 at risk EG0012 affected131 at risk EG0026 affected129 at risk
Bronchitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0004 affected129 at risk EG0013 affected131 at risk EG0021 affected129 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected129 at risk EG0012 affected131 at risk EG0022 affected129 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected129 at risk EG0011 affected131 at risk EG0028 affected129 at risk
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected129 at risk EG0015 affected131 at risk EG0021 affected129 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected129 at risk EG0017 affected131 at risk EG0024 affected129 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected129 at risk EG0015 affected131 at risk EG0022 affected129 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected129 at risk EG0015 affected131 at risk EG0022 affected129 at risk
Influenza	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected129 at risk EG0014 affected131 at risk EG0023 affected129 at risk
Insomnia	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0014 affected131 at risk EG0021 affected129 at risk
Nasopharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0006 affected129 at risk EG0015 affected131 at risk EG0028 affected129 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected129 at risk EG0014 affected131 at risk EG0026 affected129 at risk
Oedema peripheral	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected129 at risk EG0014 affected131 at risk EG0027 affected129 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected129 at risk EG0010 affected131 at risk EG0024 affected129 at risk
Upper respiratory tract	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0004 affected129 at risk EG0016 affected131 at risk EG0024 affected129 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG00010 affected129 at risk EG0018 affected131 at risk EG0029 affected129 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected129 at risk EG0010 affected131 at risk EG0023 affected129 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D003924	Diabetes Mellitus, Type 2
D050171	Dyslipidemias

ID	Title	Description
BG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
BG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
BG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
BG003	Total	Total of all reporting groups

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D052439	Lipid Metabolism Disorders

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins