Efficacy and Safety of Alogliptin Combined With Metformin... | NCT00286442

ID	Type	Description	Link
2005-004668-22	EudraCT Number
U1111-1113-8393	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 effectiveness of alogliptin in combination with metformin in individually who are inadequately controlled on metformin alone.

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 and metformin
Alogliptin 25 mg QD	Experimental	Drug: Alogliptin and metformin
Metformin	Placebo Comparator	Drug: Metformin

Name	Type	Description	Arm Group Labels	Other Names
Alogliptin and metformin	Drug	Alogliptin 12.5 mg, tablets, orally, once daily and metformin 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 metformin alone but, experiencing inadequate glycemic control. The participant should have received the metformin monotherapy for at least the 3 months prior to Screening; and must have a stable dose of greater than or equal to 1500 mg metformin for at least 8 weeks prior to randomization. Participants with a maximum tolerated dose that is documented to be less than 1500 mg of metformin may also be enrolled if this dose has been stable for 8 weeks prior to randomization.
No treatment with antidiabetic agents other than metformin within the 3 months prior to Screening. (Exception: if a participant has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)
Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2
Fasting C-peptide concentration greater than or equal to 0.8 ng per mL. (If this screening criterion is not met, the participant still qualifies if C-peptide is greater than or equal to 1.5 ng per mL after a challenge test.
Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive
If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
Systolic blood pressure less than or equal to 180 mm Hg and diastolic pressure less than or equal to 110 mm Hg
Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to 10 g per dL for females
Alanine aminotransferase less than or equal to 3 time the upper limit of normal
Serum creatinine less than1.5 mg per dL for males and less than 1.4 mg per dL for females
Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the participant is clinically euthyroid.
Neither pregnant nor lactating.
Female participants 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 participant 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 participant 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 participants 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 participant'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 or metformin is not allowed within the 3 months prior to Screening and through the completion of the end-of treatment/early termination procedures.
- Treatment with weight-loss drugs, any investigational antidiabetics, or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of-treatment/early termination procedures. Inhaled corticosteroids are allowed.
- Participants must be instructed not to 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
19125992	Result	Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 008 Group. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int J Clin Pract. 2009 Jan;63(1):46-55. doi: 10.1111/j.1742-1241.2008.01933.x.
19793357

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
FG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin 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 participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 26.

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 26.

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

Units	Counts
Participants	OG000210 OG001203 OG002103

Title

Denominators

Categories

Title	Measurements
	OG000-0.61± 0.053 OG001-0.59± 0.054 OG002-0.10± 0.076

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 OG002	Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=500 participants had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided >0.05 significance level and >=80% of participants meeting per protocol criteria.	ANCOVA	Analysis of covariance (ANCOVA) with treatment and geographic region as class variables and baseline metformin dose and baseline 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)	-0.50			2-Sided	95	-0.68

Secondary

Change From Baseline in Glycosylated Hemoglobin (Week 4).

The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.

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

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 4.

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

Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 8.

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 8.

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

Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 12.

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 12.

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

Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 16.

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 16.

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

Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 20.

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 20.

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

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

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 1.

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

Units	Counts
Participants

Secondary

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

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

Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 2.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 2.

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

Units	Counts
Participants

Secondary

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

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

Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 2. Missing data imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 4.

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

Units	Counts
Participants

Secondary

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

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

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

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 8.

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

Units	Counts
Participants

Secondary

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

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

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

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 12.

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

Units	Counts
Participants

Secondary

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

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

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

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 16.

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

Units	Counts
Participants

Secondary

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

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

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

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 20.

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

Units	Counts
Participants

Secondary

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

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

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

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 26.

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

Units	Counts

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

Posted

Number

participants

26 Weeks.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin 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 1 dose of study drug (Full Analysis Set), and who completed at least 1 study visit after baseline.

Posted

Number

participants

26 Weeks.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin 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 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

pmol/L

Baseline and Week 4.

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

Units	Counts
Participants

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 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

pmol/L

Baseline and Week 8.

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

Units	Counts
Participants

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.

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

Posted

Least Squares Mean

Standard Error

pmol/L

Baseline and Week 12.

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

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

Posted

Least Squares Mean

Standard Error

pmol/L

Baseline and Week 16.

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

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

Posted

Least Squares Mean

Standard Error

pmol/L

Baseline and Week 20.

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

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

Posted

Least Squares Mean

Standard Error

pmol/L

Baseline and Week 26.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin 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 1 dose of study drug (Full Analysis Set), and who had an insulin measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

mcIU/mL

Baseline and Week 4.

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

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

Posted

Least Squares Mean

Standard Error

mcIU/mL

Baseline and Week 8.

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

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

Posted

Least Squares Mean

Standard Error

mcIU/mL

Baseline and Week 12.

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

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

Posted

Least Squares Mean

Standard Error

mcIU/mL

Baseline and Week 16.

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

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

Posted

Least Squares Mean

Standard Error

mcIU/mL

Baseline and Week 20.

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

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

Posted

Least Squares Mean

Standard Error

mcIU/mL

Baseline and Week 26.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin 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 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

ratio

Baseline and Week 4.

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

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

Posted

Least Squares Mean

Standard Error

ratio

Baseline and Week 8.

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

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

Posted

Least Squares Mean

Standard Error

ratio

Baseline and Week 12.

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

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

Posted

Least Squares Mean

Standard Error

ratio

Baseline and Week 16.

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

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

Posted

Least Squares Mean

Standard Error

ratio

Baseline and Week 20.

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

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

Posted

Least Squares Mean

Standard Error

ratio

Baseline and Week 26.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin 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 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 4.

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

Units	Counts
Participants

Secondary

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

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

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

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 8.

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

Units	Counts
Participants

Secondary

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

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

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

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 12.

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

Units	Counts
Participants

Secondary

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

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

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

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 16.

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

Units	Counts
Participants

Secondary

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

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

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

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 20.

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

Units	Counts
Participants

Secondary

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

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

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

Posted

Least Squares Mean

Standard Error

ng/mL

Baseline and Week 26.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin 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 1 dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin 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 1 dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin 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 1 dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin 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 1 dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin 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 1 dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin 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 1 dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

ID	Title	Description
OG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
OG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin 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 1 dose of study drug (Full Analysis Set).

Posted

Number

participants

Baseline and Week 26.

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

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

Posted

Least Squares Mean

Standard Error

Baseline and Week 8.

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

Units	Counts
Participants

Secondary

Change From Baseline in Body Weight (Week 12).

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

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

Posted

Least Squares Mean

Standard Error

Baseline and Week 12.

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

Units	Counts
Participants

Secondary

Change From Baseline in Body Weight (Week 20).

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

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

Posted

Least Squares Mean

Standard Error

Baseline and Week 20.

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

Units	Counts
Participants

Secondary

Change From Baseline in Body Weight (Week 26).

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

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

Posted

Least Squares Mean

Standard Error

Baseline and Week 26.

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

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Non-cardiac chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected213 at risk EG0012 affected207 at risk EG0020 affected104 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected213 at risk EG0011 affected207 at risk EG0020 affected104 at risk
Appendicitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected213 at risk EG0010 affected207 at risk EG0020 affected104 at risk
Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected213 at risk EG0010 affected207 at risk EG0021 affected104 at risk
Postoperative wound infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected213 at risk EG0011 affected207 at risk EG0020 affected104 at risk
Pyelonephritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected213 at risk EG0010 affected207 at risk EG0021 affected104 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected213 at risk EG0011 affected207 at risk EG0020 affected104 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected213 at risk EG0010 affected207 at risk EG0021 affected104 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected213 at risk EG0010 affected207 at risk EG0020 affected104 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected213 at risk EG0011 affected207 at risk EG0020 affected104 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected213 at risk EG0010 affected207 at risk EG0020 affected104 at risk
Non-secretory adenoma of the pituitary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected213 at risk EG0010 affected207 at risk EG0020 affected104 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected213 at risk EG0010 affected207 at risk EG0020 affected104 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected213 at risk EG0011 affected207 at risk EG0020 affected104 at risk
Angina unstable	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected213 at risk EG0010 affected207 at risk EG0021 affected104 at risk
Bradycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected213 at risk EG0010 affected207 at risk EG0020 affected104 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected213 at risk EG0011 affected207 at risk EG0020 affected104 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected213 at risk EG0010 affected207 at risk EG0020 affected104 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected213 at risk EG0010 affected207 at risk EG0021 affected104 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	EG00010 affected213 at risk EG0015 affected207 at risk EG0027 affected104 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00014 affected213 at risk EG0015 affected207 at risk EG0024 affected104 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected213 at risk EG0017 affected207 at risk EG0026 affected104 at risk
Nasopharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00012 affected213 at risk EG0017 affected207 at risk EG0026 affected104 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected213 at risk EG0013 affected207 at risk EG0025 affected104 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected213 at risk EG0016 affected207 at risk EG0025 affected104 at risk
Sinusitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0005 affected213 at risk EG0014 affected207 at risk EG0025 affected104 at risk
Bronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0009 affected213 at risk EG0016 affected207 at risk EG0022 affected104 at risk
Pain in extremity	General disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected213 at risk EG0013 affected207 at risk EG0024 affected104 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected213 at risk EG0014 affected207 at risk EG0022 affected104 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona		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
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

ID	Title	Description
BG000	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
BG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
BG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin 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	Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.	6	213	62	213
EG001	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.	8	207	41	207
EG002	Placebo	Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.	4	104	37	104