Study of Alogliptin Combined With Sulfonylurea in Subject... | NCT00286468

ID	Type	Description	Link
2005-004667-36	EudraCT Number
U1111-1113-8506	Registry Identifier	WHO

Status Module

Description Module

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

Name	Type	Description	Arm Group Labels	Other Names
Alogliptin and glyburide	Drug	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide 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 sulfonylurea alone but experiencing inadequate glycemic control. Should have received the sulfonylurea monotherapy for at least the 3 months prior to Screening; has been on a stable sulfonylurea dose equivalent to at least 10 mg of glyburide (Exception: documented maximum tolerated dose equivalent to less than 10 mg but at least 5 mg glyburide) for at least 8 weeks.
No treatment with antidiabetic agents other than 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/mL. (If this screening criterion is not met, the subject still qualifies if C-peptide is greater than or equal to 1.5 ng/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 to180 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 to 10 g per dL for females
Alanine aminotransferase less than or equal to 3 time the upper limit of normal.
Serum creatinine ≤2.0 mg/dL (≤17 micromol/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 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 and Treatments:
- Treatment with antidiabetic agents other than study drug or glyburide 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, Bosentan (used for the treatment of pulmonary hypertension), 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
19125778	Result	Pratley RE, Kipnes MS, Fleck PR, Wilson C, Mekki Q; Alogliptin Study 007 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab. 2009 Feb;11(2):167-76. doi: 10.1111/j.1463-1326.2008.01016.x.
19793357	Result

Results Section

Participant Flow Module

Arm/Group Information

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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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 visit. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 26.

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

Units	Counts
Participants	OG000201 OG001197 OG00297

Title

Denominators

Categories

Title	Measurements
	OG0000.01± 0.084 OG001-0.38± 0.058 OG002-0.52± 0.058

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 week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per-protocol analysis set assuming SD=0.8%, 2-sided >0.05 significance level, and >=80% of subjects meeting per protocol criteria.	ANCOVA	Treatment and geographic region as class variables; baseline glyburide dose and baseline value for glycosylated hemoglobin 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)	-0.39			2-Sided	95	-0.59

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 week 4 due to unavailable prior value to carry forward.

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 glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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

mg/dL

Baseline and Week 8.

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

Units

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 12).

The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.

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 glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.

Units

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

mg/dL

Baseline and Week 16.

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

Units

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

mg/dL

Baseline and Week 20.

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

Units

Secondary

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

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

Randomized 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

mg/dL

Baseline and Week 1.

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

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

mg/dL

Baseline and Week 2.

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

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

mg/dL

Baseline and Week 4.

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

Units	Counts
Participants

Secondary

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

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

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

Units	Counts
Participants

Secondary

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

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

Randomized participants who received at least one dose of study drug (Full Analysis Set) and have at least 1 post-baseline measurement for fasting plasma glucose.

Posted

Number

participants

26 Weeks.

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

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

pmol/L

Baseline and Week 4.

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

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

pmol/L

Baseline and Week 8.

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

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

mcIU/mL

Baseline and Week 4.

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

Units	Counts

Secondary

Change From Baseline in Insulin (Week 8).

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

mcIU/mL

Baseline and Week 8.

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

mcIU/mL

Baseline and Week 16.

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

mcIU/mL

Baseline and Week 20.

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

mcIU/mL

Baseline and Week 26.

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

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

ratio

Baseline and Week 4.

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

Units

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.

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

ratio

Baseline and Week 8.

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

Units

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 glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.

Units	Counts

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 glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.

Units	Counts

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 glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.

Units	Counts

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 glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.

Units	Counts

Secondary

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

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

Randomized 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

ng/mL

Baseline and Week 4.

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

Units	Counts

Secondary

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

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

Randomized 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

ng/mL

Baseline and Week 8.

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

Units	Counts

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 glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
OG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
OG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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 affected99 at risk EG0010 affected203 at risk EG0022 affected198 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected203 at risk EG0020 affected198 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected203 at risk EG0020 affected198 at risk
Myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected203 at risk EG0020 affected198 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0010 affected203 at risk EG0021 affected198 at risk
Non-cardiac chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected203 at risk EG0020 affected198 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected203 at risk EG0020 affected198 at risk
Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected203 at risk EG0020 affected198 at risk
Device related infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected203 at risk EG0020 affected198 at risk
Erysipelas	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0010 affected203 at risk EG0021 affected198 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected203 at risk EG0020 affected198 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected203 at risk EG0020 affected198 at risk
Pyelonephritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0010 affected203 at risk EG0021 affected198 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0010 affected203 at risk EG0021 affected198 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0010 affected203 at risk EG0021 affected198 at risk
electrocardiogram change	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected203 at risk EG0020 affected198 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected203 at risk EG0020 affected198 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected203 at risk EG0020 affected198 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected203 at risk EG0020 affected198 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0010 affected203 at risk EG0021 affected198 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0010 affected203 at risk EG0021 affected198 at risk
Facial palsy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0010 affected203 at risk EG0021 affected198 at risk
Mental status changes	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected203 at risk EG0020 affected198 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0010 affected203 at risk EG0021 affected198 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0010 affected203 at risk EG0021 affected198 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 affected99 at risk EG0014 affected203 at risk EG0025 affected198 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected99 at risk EG0015 affected203 at risk EG00211 affected198 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected99 at risk EG0017 affected203 at risk EG00211 affected198 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 affected99 at risk EG0019 affected203 at risk EG00210 affected198 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected99 at risk EG0014 affected203 at risk EG0029 affected198 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0018 affected203 at risk EG0029 affected198 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected99 at risk EG0018 affected203 at risk EG0028 affected198 at risk
Influenza	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 affected99 at risk EG0014 affected203 at risk EG0025 affected198 at risk
Nasopharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected99 at risk EG0018 affected203 at risk EG0028 affected198 at risk
Oedema peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0014 affected203 at risk EG0027 affected198 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
D013453	Sulfonylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457	Sulfur Compounds

ID	Title	Description
BG000	Placebo	Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
BG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
BG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide 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 glyburide for up to 26 weeks.	2	99	23	99
EG001	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.	11	203	49	203
EG002	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.	11	198	64	198