Efficacy and Safety of Alogliptin in Subjects With Type 2... | NCT00286455

ID	Type	Description	Link
2005-004670-24	EudraCT Number
U1111-1113-8462	Registry Identifier	WHO

Description Module

Detailed Description

There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.

The aim of the current study is to evaluate the efficacy of alogliptin in subjects with type 2 diabetes mellitus who are inadequately controlled and who have failed treatment with diet and exercise. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).

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

Name	Type	Description	Arm Group Labels	Other Names
Alogliptin	Drug	Alogliptin 12.5 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

Type 2 diabetes mellitus, experiencing inadequate glycemic control, and are receiving no current antidiabetic therapy. Subjects will qualify if both of the following conditions apply:
- Subject has failed treatment with diet and exercise for at least one month prior to Screening
- Subject has received less than 7 days of any antidiabetic therapy within the 3 months prior to Screening Diagnosis of type 2 diabetes must be based on current American Diabetes Association criteria.
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 (greater than or equal to 0.26 nmol per L). (If this screening criterion is not met, the subject still qualifies if C-peptide greater than or equal to1.5 ng per mL (greater than or equal to 0.50 nmol per L) 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 (greater than or equal to 120 gm per L) for males and greater than or equal to 10 g per dL (greater than or equal to 100 gm per L) for females
Alanine aminotransferase less than or equal to 3 times the upper limit of normal
Serum creatinine less than or equal to 2.0 mg per dL (less than or equal to 17 micromol per L)
Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid
Neither pregnant (confirmed by laboratory testing in females of childbearing potential) 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 than1000 μg per mg (greater than 113 mg per mol) 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 1 or cervical intraepithelial neoplasia 2 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 study drug following enrollment in the study) is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures. (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)
- 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 are not to take any medications, including over-the-counter products, without first consulting with the Study Doctor.

Name	Affiliation	Role
VP Biological Sciences	Takeda	Study Director

PubMed Identifier	Type	Citation	Retractions
18809631	Result	DeFronzo RA, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 010 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. Diabetes Care. 2008 Dec;31(12):2315-7. doi: 10.2337/dc08-1035. Epub 2008 Sep 22.
19793357

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

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

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 26.

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

Units	Counts
Participants	OG00063 OG001131 OG002128

Title

Denominators

Categories

Title	Measurements
	OG000-0.02± 0.094 OG001-0.56± 0.065 OG002-0.59± 0.066

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. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided >0.05 significance level and >=80% of subjects meeting per protocol criteria.	ANCOVA	Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) 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)	-0.54			2-Sided	95	-0.76

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 one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 4.

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

Units	Counts

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily 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.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 16.

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

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 20.

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

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 26.

ID	Title	Description
OG000	Placebo QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily 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 at any measurement time point 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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily 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 participants who received at least one dose of study drug (Full Analysis Set).

Posted

Number

participants

26 Weeks.

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

Units	Counts
Participants	OG000

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts
Participants

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts
Participants

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts
Participants

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts
Participants

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

ϻIU/mL

Baseline and Week 4.

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

Units	Counts
Participants

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

ϻIU/mL

Baseline and Week 8.

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

Units	Counts
Participants

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

ϻIU/mL

Baseline and Week 12.

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

Units	Counts
Participants

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

ϻIU/mL

Baseline and Week 16.

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

Units	Counts
Participants

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

ϻIU/mL

Baseline and Week 20.

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

Units	Counts
Participants

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

ϻIU/mL

Baseline and Week 26.

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

Units	Counts
Participants

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts
Participants

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts
Participants

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts
Participants

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily 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.

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 4.

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

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 8.

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

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 12.

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

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 16.

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

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 20.

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

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 26.

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

Units	Counts
Participants

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 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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily 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 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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily 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 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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts
Participants

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts
Participants

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts
Participants

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.

Units	Counts
Participants

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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily 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.

Posted

Least Squares Mean

Standard Error

Baseline and Week 12.

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

Posted

Least Squares Mean

Standard Error

Baseline and Week 20.

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

Posted

Least Squares Mean

Standard Error

Baseline and Week 26.

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

Units	Counts
Participants

Secondary

Change From Baseline in Glucagon (Week 4).

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

Posted

Mean

Standard Deviation

pg/mL

Baseline and Week 4.

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

Units	Counts
Participants

Secondary

Change From Baseline in Glucagon (Week 8).

The change between the value of glucagon collected at week 8 and glucagon 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).) Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.

Posted

Mean

Standard Deviation

pg/mL

Baseline and Week 8.

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

Units	Counts
Participants

Secondary

Change From Baseline in Glucagon (Week 12).

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

Posted

Mean

Standard Deviation

pg/mL

Baseline and Week 12.

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

Units	Counts
Participants

Secondary

Change From Baseline in Glucagon (Week 16).

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

Posted

Mean

Standard Deviation

pg/mL

Baseline and Week 16.

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

Units	Counts
Participants

Secondary

Change From Baseline in Glucagon (Week 20).

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

Posted

Mean

Standard Deviation

pg/mL

Baseline and Week 20.

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

Units	Counts
Participants

Secondary

Change From Baseline in Glucagon (Week 26).

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

Posted

Mean

Standard Deviation

pg/mL

Baseline and Week 26.

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

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected64 at risk EG0010 affected133 at risk EG0021 affected132 at risk
Palpitations	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected64 at risk EG0011 affected133 at risk EG0020 affected132 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected64 at risk EG0011 affected133 at risk EG0020 affected132 at risk
Noncardiac chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected64 at risk EG0011 affected133 at risk EG0020 affected132 at risk
Gastroenteritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected64 at risk EG0011 affected133 at risk EG0020 affected132 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected64 at risk EG0010 affected133 at risk EG0020 affected132 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected64 at risk EG0010 affected133 at risk EG0020 affected132 at risk
Intermittent claudication	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected64 at risk EG0010 affected133 at risk EG0021 affected132 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected64 at risk EG0011 affected133 at risk EG0020 affected132 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0006 affected64 at risk EG0015 affected133 at risk EG0026 affected132 at risk
Nasopharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0005 affected64 at risk EG00112 affected133 at risk EG00210 affected132 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected64 at risk EG00110 affected133 at risk EG0029 affected132 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected64 at risk EG0013 affected133 at risk EG0021 affected132 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected64 at risk EG0017 affected133 at risk EG0022 affected132 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected64 at risk EG0017 affected133 at risk EG0025 affected132 at risk
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected64 at risk EG0014 affected133 at risk EG0022 affected132 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected64 at risk EG0014 affected133 at risk EG0025 affected132 at risk
Pharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected64 at risk EG0015 affected133 at risk EG0022 affected132 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected64 at risk EG0012 affected133 at risk EG0023 affected132 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected64 at risk EG0013 affected133 at risk EG0021 affected132 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected64 at risk EG0012 affected133 at risk EG0021 affected132 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected64 at risk EG0012 affected133 at risk EG0024 affected132 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected64 at risk EG0010 affected133 at risk EG0021 affected132 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected64 at risk EG0010 affected133 at risk EG0020 affected132 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected64 at risk EG0011 affected133 at risk EG0022 affected132 at risk
Sinusitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected64 at risk EG0010 affected133 at risk EG0022 affected132 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0002 affected64 at risk EG0011 affected133 at risk EG0020 affected132 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	Title	Description
BG000	Placebo QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
BG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
BG002	Alogliptin 25 mg QD	Alogliptin 25 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 QD	Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.	2	64	32	64
EG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.	5	133	48	133
EG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.	1	132	39	132