Efficacy and Safety of Alogliptin Compared to Glipizide i... | NCT00707993

NCT00707993

ID	Type	Description	Link
2008-000959-10	Registry Identifier	EudraCT
U1111-1112-7905	Registry Identifier	WHO

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Detailed Description

Type 2 diabetes is among the most common chronic condition in adults 65 years of age or older. A recent National Health and Nutrition Examination Survey reported that more than 20% of adults aged 65 years or older have diabetes. These individuals are often under-treated with respect to glucose-lowering medications, and their care is complicated by the extent of their clinical and functional status. Age-related changes in physiology, diabetes-associated illnesses and other illnesses (such as renal, cardiac, and hepatic insufficiency), as well as use of multiple medications make standard oral anti-hyperglycemic therapy and insulin use problematic. In addition, hypoglycemia is more common and severe in older rather than younger patients taking oral antidiabetic drugs which can precipitate serious events such as falls and hip fractures. While avoidance of hypoglycemia is paramount in elderly diabetic patients, many commonly used medications are associated with a substantial risk for hypoglycemia. New classes of drug which avoid such complications in the elderly population are of increasing interest as this population continues to expand.

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.

This study will compare the effectiveness and safety of alogliptin with that of glipizide (a commonly used diabetes medication) in adults who are 65 to 90 years of age with Type 2 diabetes. Individuals who participate in this study will either have failed diet and exercise therapy alone during the 2 months before Screening, or will have been receiving a single oral antidiabetic medication without obtaining good blood glucose (sugar) control.

Each participant will be required to commit to screening visits. Study participation is anticipated to be up to 59 weeks.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Alogliptin 25 mg QD	Experimental		Drug: Alogliptin
Glipizide 5 mg QD	Active Comparator		Drug: Glipizide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alogliptin	Drug	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.	Alogliptin 25 mg QD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin at Week 52.	The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.	Baseline and Week 52.

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin	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 each week indicated including final visit relative to baseline.	Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has a diagnosis of type 2 diabetes mellitus with either:
- Failed diet and exercise therapy alone as demonstrated by inadequate glycemic control while receiving no antidiabetic treatment within the two months prior to Screening, or
- Failed treatment with oral monotherapy alone (may include treatment with two or more antidiabetic agents if for less than 7 days) as demonstrated by inadequate glycemic control within the two months prior to Screening.
Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.
If regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening.
Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of 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.

Exclusion Criteria:

Systolic blood pressure greater than or equal to 160 mm Hg and/or diastolic pressure greater than or equal to 100 mm Hg.
Hemoglobin less than or equal to 12 g/dL for males or less than or equal to 10 g/dL for females.
Alanine aminotransferase greater than or equal to 3 times the upper limit of normal.
Calculated creatinine clearance less than or equal to 50 mL/min.
Thyroid-stimulating hormone level outside of the normal range.
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.
History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
History of treated diabetic gastroparesis, gastric banding, or gastric bypass surgery.
New York Heart Association Class III or IV heart failure regardless of therapy.
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 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.
History of treatment with any weight-loss drugs or oral or systemically injected glucocorticoids within the 3 months prior to Screening.
Receipt of any investigational drug within the 30 days prior to Screening.
Prior treatment in an investigational study of alogliptin.
Clinically significant medical abnormality or disease or clinically significant abnormal findings at Screening (other than type 2 diabetes) that, in the opinion of the investigator, should exclude the participant from the study.
Has donated more than 400 mL of blood within the 90 days preceding their participation in the study.
Has hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor drug.

Contacts/Locations Module

Name	Affiliation	Role
VP Biological Sciences	Takeda	Study Director

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
FG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
BG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00070.1± 4.42 BG00169.8± 4.07 BG00269.9± 4.24

Age, Customized

Number

participants

Title

Denominators

Categories

<75 years

Title	Measurements
	BG000186 BG001193 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000120 BG001123 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00079 BG00170 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG00012 BG00113 BG002

Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00078.60± 14.842 BG00178.81± 15.239 BG002

Body Mass Index (BMI)

Mean

Standard Deviation

kg/m2

Title

Denominators

Categories

Title	Measurements
	BG00029.58± 4.348 BG00130.02± 4.459 BG002

Diabetes duration

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0006.25± 6.285 BG0015.94± 6.276 BG002

Glomerular Filtration Rate (GFR)

Using the Modification of Diet in Renal Disease method.

Mean

Standard Deviation

mL/min/1.73 m2

Title

Denominators

Categories

Title	Measurements
	BG00073.62± 14.762 BG00172.89± 15.524

Smoking history

Number

participants

Title

Denominators

Categories

Never smoked

Title	Measurements
	BG000160 BG001168 BG002

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 at Week 52.

The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.

Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000180 OG001162

Title

Denominators

Categories

Title	Measurements
	OG000-0.14± 0.063 OG001-0.09± 0.067

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	Primary null hypothesis: the average Week 52 HbA1c change from Baseline for alogliptin is inferior to that for glipizide (1-sided 97.5% CI [alpha=0.025] compared to non-inferiority margin of 0.4%). If the primary null hypothesis was rejected (non-inferiority demonstrated), an additional comparison for statistical superiority of alogliptin was performed. The CI was re-evaluated; statistical superiority declared if the upper limit was < 0%.	ANCOVA	Treatment, randomization schedule, and geographic region as class effects; baseline value for the endpoint as a continuous covariate.			Mean Difference (Final Values)	-0.05			1-Sided	97.5		0.13				No

Secondary

Change From Baseline in Glycosylated Hemoglobin

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 each week indicated including final visit relative to baseline.

Posted

Least Squares Mean

Standard Error

percentage of Glycosylated Hemoglobin

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants

Secondary

Incidence of Hypoglycemia

Percentage of participants with at least one hypoglycemic episode during 52 week study.

Percentages based on the number of Safety Set participants in each treatment group.

Posted

Number

percentage of participants

On occurrence (up to 52 weeks).

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).

The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study.

All randomized participants who had at least 1 dose of study medication (full analysis set).

Posted

Number

participants

On Occurrence (up to 52 weeks).

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Incidence of Hyperglycemic Rescue

The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study.

All randomized participants who had at least 1 dose of study medication (full analysis set). Participants who discontinued prior to Week 2 were excluded from analysis.

Posted

Number

participants

On Occurrence (up to 52 weeks).

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Fasting Plasma Glucose

The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline.

All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in 2-hour Postprandial Glucose

The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink.

All randomized participants who had at least 1 dose of study medication (full analysis set).

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Fasting Proinsulin

The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline.

All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.

Posted

Least Squares Mean

Standard Error

pmol/L

Baseline, Week 12, Week 26, Week 42 and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Insulin

The change between the value of insulin collected at each week indicated including final visit relative to baseline.

All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mcIU/mL

Baseline, Week 12, Week 26, Week 42 and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Proinsulin/Insulin Ratio

The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline.

All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.

Posted

Least Squares Mean

Standard Error

ratio

Baseline, Week 12, Week 26, Week 42 and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Homeostasis Model Assessment of Beta Cell Function

The change between homeostasis model assessment of beta cell function collected at each week indicated including final visit relative to baseline. Homeostasis model assessment of beta cell function measures beta cell function, calculated by a constant (20) times insulin, divided by fasting plasma glucose minus a constant (3.5).

All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.

Posted

Least Squares Mean

Standard Error

percent score of beta cell function

Baseline, Week 12, Week 26, Week 42 and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Body Weight

The change in body weight measured at each week indicated including final visit from baseline.

All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.

Posted

Least Squares Mean

Standard Error

Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Lipids (Total Cholesterol)

The change in total cholesterol measured at each week indicated including final visit from baseline.

All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol)

The change in high-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.

All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol)

The change in low-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.

All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Lipids (Triglycerides)

The change in triglycerides measured at each week indicated including final visit from baseline.

All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in High Sensitivity C-reactive Protein

The change between the high sensitivity C-reactive protein value collected at each week indicated including final visit from baseline.

All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.

Posted

Least Squares Mean

Standard Error

mg/L

Baseline, Week 12, Week 26, Week 42 and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Incidence of Subjects Achieving Glycosylated Hemoglobin <=7%

The percentage of participants with a value for the percentage of glycosylated hemoglobin (HbA1c; the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5 and 7.0% during the 52 week study.

All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.

Posted

Number

percentage of participants

Baseline and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Secondary

Incidence of Glycosylated Hemoglobin Decrease From Baseline.

The percentage 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, 1.0, 1.5 and 2.0% during the 52 week study.

All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.

Posted

Number

percentage of participants

Baseline and Week 52.

ID	Title	Description
OG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
OG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.			16	222	103	222
EG001	Glipizide 5 mg QD	Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.			13	219	105	219

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Cardiac failure	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0011 affected219 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected222 at risk EG0011 affected219 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0011 affected219 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected222 at risk EG0012 affected219 at risk
Coronary artery disease	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Diverticulitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Dizziness	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected222 at risk EG0011 affected219 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0002 affected222 at risk EG0010 affected219 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected222 at risk EG0011 affected219 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected222 at risk EG0011 affected219 at risk
Left ventricular failure	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Myocardial infarction	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected222 at risk EG0011 affected219 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected222 at risk EG0011 affected219 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected222 at risk EG0011 affected219 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected222 at risk EG0011 affected219 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected222 at risk EG0011 affected219 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected222 at risk EG0010 affected219 at risk
Urosepsis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected222 at risk EG0011 affected219 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG00010 affected222 at risk EG00112 affected219 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0009 affected222 at risk EG00111 affected219 at risk
Bronchitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0006 affected222 at risk EG0019 affected219 at risk
C-reactive protein increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0009 affected222 at risk EG0013 affected219 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0009 affected222 at risk EG00114 affected219 at risk
Dizziness	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG00013 affected222 at risk EG00118 affected219 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0005 affected222 at risk EG00110 affected219 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0007 affected222 at risk EG0011 affected219 at risk
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG00016 affected222 at risk EG00115 affected219 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG00012 affected222 at risk EG00110 affected219 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected222 at risk EG0018 affected219 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00013 affected222 at risk EG00110 affected219 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0007 affected222 at risk EG0018 affected219 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected222 at risk EG0018 affected219 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0006 affected222 at risk EG0017 affected219 at risk
Pharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0005 affected222 at risk EG0017 affected219 at risk
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected222 at risk EG0017 affected219 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00012 affected222 at risk EG0015 affected219 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00026 affected222 at risk EG00123 affected219 at risk

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

ID	Term
C520853	alogliptin
D005913	Glipizide

Superiority or Other

Facility	Status	City	State	ZIP	Country	Contacts
		Alexander City	Alabama		United States

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

ID	Term
D013453	Sulfonylurea Compounds
D013450	Sulfones
D013457	Sulfur Compounds
D009930	Organic Chemicals