Study of Alogliptin Combined With Pioglitazone in Subject... | NCT00286494

ID	Type	Description	Link
2005-004669-40	EudraCT Number
U1111-1113-8552	Registry Identifier	WHO

Status Module

Description Module

Label	Type	Intervention Names
Placebo	Active Comparator	Drug: Pioglitazone
Alogliptin 12.5 mg QD	Experimental	Drug: Alogliptin and pioglitazone
Alogliptin 25 mg QD	Experimental	Drug: Alogliptin and pioglitazone

Name	Type	Description	Arm Group Labels	Other Names
Alogliptin and pioglitazone	Drug	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily 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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Diagnosis of type 2 diabetes mellitus currently treated with a thiazolidinedione either alone or in combination with metformin or a sulfonylurea but who are experiencing inadequate glycemic control. The subject should have received the thiazolidinedione therapy (rosiglitazone or pioglitazone) either alone or in combination with metformin or a sulfonylurea for at least the 3 months prior to Screening and must have been on a stable dose for all their antidiabetic treatments for at least the month prior to Screening.
No treatment with antidiabetic agents other than a thiazolidinedione alone or in combination with either metformin or a sulfonylurea within the 3 months prior to Screening. (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)
Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2
Fasting C-peptide concentration greater than or equal to 0.8 ng per mL. (If this screening criterion is not met, the subject still qualifies if C-peptide is greater than or equal to 1.5 ng per mL after a challenge test.)
Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive.
If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
Systolic blood pressure less than or equal to 180 mm Hg and diastolic pressure less than or equal to 110 mm Hg.
Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to10 g per dL for females.
Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.
Serum creatinine less than or equal to 2.0 mg per dL.
Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid.
Neither pregnant nor lactating.
Female subjects of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in the study.
Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
No major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
Able and willing to provide written informed consent.

Exclusion Criteria

Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the subject may be rescreened within 1 week.
History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.)
History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
History of treated diabetic gastric paresis.
New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study.
History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening
History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
History of a psychiatric disorder that will affect the subject's ability to participate in the study.
History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
History of alcohol or substance abuse within the 2 years prior to Screening.
Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening.
Prior treatment in an investigational study of alogliptin.
Excluded Medications:
- Treatment with antidiabetic agents other than a thiazolidinedione alone or in combination with either metformin or a sulfonylurea is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures.
- Treatment with weight-loss drugs, any investigational antidiabetics, or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of-treatment/early termination procedures. Inhaled corticosteroids are allowed.

Subjects must not take any medications, including over-the-counter products, without first consulting with the investigator.

Name	Affiliation	Role
VP Biological Sciences	Takeda	Study Director

PubMed Identifier	Type	Citation	Retractions
19650752	Result	Pratley RE, Reusch JE, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 009 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin. 2009 Oct;25(10):2361-71. doi: 10.1185/03007990903156111.
19793357

ID	Title	Description
FG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
FG001	Alogliptin 12.5 mg QD

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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 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).

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts
Participants	OG00095 OG001196 OG002195

Title

Denominators

Categories

Title	Measurements
	OG000-0.19± 0.081 OG001-0.66± 0.056 OG002-0.80± 0.056

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	Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 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 95% 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.	ANCOVA	Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.	<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)	-0.47			2-Sided	95	-0.67

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily 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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily 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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily 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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

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 participants who received at least one dose of study drug (Full Analysis Set) and had at least 1 post-baseline FPG measurement.

Posted

Number

participants

26 Weeks.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 participants who received at least one dose of study drug (Full Analysis Set)and at least 1 post-baseline measurement.

Posted

Number

participants

26 Weeks.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting Proinsulin (Week 4).

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

Posted

Least Squares Mean

Standard Error

pmol/L

Baseline and Week 4.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Fasting Proinsulin (Week 8).

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

Posted

Least Squares Mean

Standard Error

pmol/L

Baseline and Week 8.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Fasting Proinsulin (Week 12).

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

Posted

Least Squares Mean

Standard Error

pmol/L

Baseline and Week 12.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Fasting Proinsulin (Week 16).

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

Posted

Least Squares Mean

Standard Error

pmol/L

Baseline and Week 16.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Fasting Proinsulin (Week 20).

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

Posted

Least Squares Mean

Standard Error

pmol/L

Baseline and Week 20.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Fasting Proinsulin (Week 26).

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

Posted

Least Squares Mean

Standard Error

pmol/L

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Insulin (Week 4).

The change between the value of insulin collected at week 4 and insulin collected at baseline.

Posted

Least Squares Mean

Standard Error

mcIU/mL

Baseline and Week 4.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Insulin (Week 8).

The change between the value of insulin collected at week 8 and insulin collected at baseline.

Posted

Least Squares Mean

Standard Error

mcIU/mL

Baseline and Week 8.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

Secondary

Change From Baseline in Insulin (Week 12).

The change between the value of insulin collected at week 12 and insulin collected at baseline.

Posted

Least Squares Mean

Standard Error

mcIU/mL

Baseline and Week 12.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units

Secondary

Change From Baseline in Insulin (Week 16).

The change between the value of insulin collected at week 16 and insulin collected at baseline.

Posted

Least Squares Mean

Standard Error

mcIU/mL

Baseline and Week 16.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units

Secondary

Change From Baseline in Insulin (Week 20).

The change between the value of insulin collected at week 20 and insulin collected at baseline.

Posted

Least Squares Mean

Standard Error

mcIU/mL

Baseline and Week 20.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units

Secondary

Change From Baseline in Insulin (Week 26).

The change between the value of insulin collected at week 26 and insulin collected at baseline.

Posted

Least Squares Mean

Standard Error

mcIU/mL

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Proinsulin/Insulin Ratio (Week 4).

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.

Posted

Least Squares Mean

Standard Error

ratio

Baseline and Week 4.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Proinsulin/Insulin Ratio (Week 8).

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.

Posted

Least Squares Mean

Standard Error

ratio

Baseline and Week 8.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Proinsulin/Insulin Ratio (Week 12).

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.

Posted

Least Squares Mean

Standard Error

ratio

Baseline and Week 12.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Proinsulin/Insulin Ratio (Week 16).

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.

Posted

Least Squares Mean

Standard Error

ratio

Baseline and Week 16.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Proinsulin/Insulin Ratio (Week 20).

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.

Posted

Least Squares Mean

Standard Error

ratio

Baseline and Week 20.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Proinsulin/Insulin Ratio (Week 26).

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.

Posted

Least Squares Mean

Standard Error

ratio

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units

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.

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units

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 participants who received at least one dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

Secondary

Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.

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

Randomized participants who received at least one dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 participants who received at least one dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 participants who received at least one dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units

Secondary

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

Randomized participants who received at least one dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units

Secondary

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

Randomized participants who received at least one dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units

Secondary

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

Randomized participants who received at least one dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units

Secondary

Change From Baseline in Body Weight (Week 8).

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

Posted

Least Squares Mean

Standard Error

Baseline and Week 8.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Secondary

Change From Baseline in Body Weight (Week 12).

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

Posted

Least Squares Mean

Standard Error

Baseline and Week 12.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

Secondary

Change From Baseline in Body Weight (Week 20).

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

Posted

Least Squares Mean

Standard Error

Baseline and Week 20.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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.

Posted

Least Squares Mean

Standard Error

Baseline and Week 26.

ID	Title	Description
OG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.

Units

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0011 affected198 at risk EG0022 affected199 at risk
Angina pectoris	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0011 affected198 at risk EG0021 affected199 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected198 at risk EG0022 affected199 at risk
Coronary artery disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0011 affected198 at risk EG0020 affected199 at risk
Appendicitis perforated	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0011 affected198 at risk EG0020 affected199 at risk
Sudden death	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0011 affected198 at risk EG0020 affected199 at risk
Serum sickness	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected198 at risk EG0021 affected199 at risk
Appendicitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected97 at risk EG0010 affected198 at risk EG0021 affected199 at risk
Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected198 at risk EG0022 affected199 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected198 at risk EG0021 affected199 at risk
Viral infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected198 at risk EG0021 affected199 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected198 at risk EG0021 affected199 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected97 at risk EG0010 affected198 at risk EG0020 affected199 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected97 at risk EG0010 affected198 at risk EG0020 affected199 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected97 at risk EG0010 affected198 at risk EG0020 affected199 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected198 at risk EG0021 affected199 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected97 at risk EG0010 affected198 at risk EG0020 affected199 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0011 affected198 at risk EG0020 affected199 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected198 at risk EG0021 affected199 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected97 at risk EG0010 affected198 at risk EG0021 affected199 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Oedema peripheral	General disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected97 at risk EG00112 affected198 at risk EG00211 affected199 at risk
Nasopharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0006 affected97 at risk EG0018 affected198 at risk EG00214 affected199 at risk
Sinusitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0006 affected97 at risk EG0015 affected198 at risk EG0024 affected199 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0005 affected97 at risk EG00111 affected198 at risk EG00210 affected199 at risk
Influenza	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0004 affected97 at risk EG0013 affected198 at risk EG00211 affected199 at risk
Bronchitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0005 affected97 at risk EG0014 affected198 at risk EG0023 affected199 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected97 at risk EG0018 affected198 at risk EG00210 affected199 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected97 at risk EG0019 affected198 at risk EG0026 affected199 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected97 at risk EG0019 affected198 at risk EG0024 affected199 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected97 at risk EG0013 affected198 at risk EG0028 affected199 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected97 at risk EG0016 affected198 at risk EG0028 affected199 at risk
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected97 at risk EG0017 affected198 at risk EG0023 affected199 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected97 at risk EG0015 affected198 at risk EG0025 affected199 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected97 at risk EG0016 affected198 at risk EG0021 affected199 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected97 at risk EG0012 affected198 at risk EG0021 affected199 at risk
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected97 at risk EG0014 affected198 at risk EG0024 affected199 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0003 affected97 at risk EG0010 affected198 at risk EG0021 affected199 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected97 at risk EG0012 affected198 at risk EG0022 affected199 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

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

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

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
BG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
BG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
BG003	Total	Total of all reporting groups

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 pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.	4	97	38	97
EG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.	5	198	76	198
EG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.	13	199	79	199