Efficacy and Safety of Alogliptin and Metformin Fixed-Dos... | NCT01890122

NCT01890122

ID	Type	Description
U1111-1139-0497	Registry Identifier	WHO
NMRR-12-799-12754	Registry Identifier	NMRR
CTR20130254	Registry Identifier	SFDA CTR
1036022140	Registry Identifier	TCTIN

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metformin HCl 500 mg	Active Comparator	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.	Drug: Metformin HCl Drug: Alogliptin Placebo Drug: Alogliptin and Metformin FDC Placebo
Alogliptin 12.5 mg	Active Comparator	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.	Drug: Alogliptin Drug: Metformin Placebo Drug: Alogliptin and Metformin FDC Placebo
Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Experimental	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.	Drug: Alogliptin and Metformin Fixed-Dose Combination (FDC) Drug: Alogliptin Placebo Drug: Metformin Placebo
Placebo	Placebo Comparator	Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Name	Type	Description	Arm Group Labels	Other Names
Alogliptin	Drug	Alogliptin tablets	Alogliptin 12.5 mg	SYR-322; Nesina

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)	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 early termination relative to baseline. Negative change indicates better glycemic control.	Baseline and Week 26 (or Early termination)

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in HbA1c at Weeks 4, 8, 12, 16 and 20	The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 4, 8, 12, 16 and 20 relative to baseline. Negative change indicates better glycemic control.	Baseline and Weeks 4, 8, 12, 16 and 20

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Has a historical diagnosis of Type 2 diabetes mellitus (T2DM).
Male or female and aged 18 to 75 years, inclusive.
Body mass index (BMI) between 20 and 45 kg/m^2, inclusive.
A female of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
Is experiencing inadequate glycemic control defined as glycosylated hemoglobin (HbA1c) concentration between 7.5% and 10%, inclusive, and has been treated with diet and exercise for at least 2 months prior to Screening. (Exception: a participant who has received any other diabetic therapy for less than 7 days in total within the 2 months prior to the screening, can be included).
If male, has a hemoglobin >12 g/dL (>120 g/L) at Screening or if female, has a hemoglobin >10 g/dL (>100 g/L) at Screening.
If male, has a serum creatinine <1.5 mg/dL at Screening or if female, has a serum creatinine <1.4 mg/dL at Screening, and estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m^2 based on calculation using the Modification of Diet in Renal Disease (MDRD) at Screening.
Willing and able to monitor their own blood glucose concentrations using a home glucose monitor and complete a subject diary.

Exclusion Criteria:

Participated in another clinical study within 90 days prior to Screening.
Received any investigational compound within 30 days prior to Randomization.
Received a dipeptidyl peptidase-4 (DPP-4) inhibitor within 3 months prior to screening.
History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
History of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery.
History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
Chronic pancreatitis and/or history of acute pancreatitis.
Systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg at Screening.
History of any hemoglobinopathy or diagnosis of chronic anemia.
New York Heart Association Class III or IV heart failure. (Participants who are stable at Class I or II and are currently treated, are candidates for the study.)
History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
History of any cancer, other than squamous cell or basal cell carcinoma of the skin, which has not been in full remission for at least 5 years prior to Screening. Participants with a history of treated cervical intraepithelial neoplasia [CIN] I or CIN II are allowed.
Significant clinical sign or symptom of hepatopathy, acute or chronic hepatitis, human immunodeficiency virus or alanine aminotransferase (ALT) is 2.5 times above upper limit of normal value.
History of angioedema in association with use of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB).
History of hypersensitivity or allergies to any DPP-4 inhibitor and/or metformin or related compounds.
Has used oral or systemically injected glucocorticoids (including intra-articular injection) or has used weight-loss drugs within 2 months prior to Screening. (Inhaled or topical corticosteroids were allowed.)
History of alcohol or substance abuse within 2 years prior to Screening.
Has used medicine for weight loss within 60 days prior to Screening (such as Xenical, Sibutramine, Phenylpropanolamine or similar nonprescription drugs).
History of organ transplantation.
Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
Has, in the judgment of the investigator, any major illness or debility that may prohibit the participant from completing the study.
If female, is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Takeda	Study Director

References Module

Label	URL
The Alogliptin-Metformin Fixed Dose Combination (KAZANO) were approved in the United States (US) on 25 January 2013.	View source

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	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
FG001	Alogliptin 12.5 mg

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

Drug: Alogliptin Placebo
Drug: Metformin Placebo
Drug: Alogliptin and Metformin FDC Placebo

FG000162 subjectsStarted = Enrolled set which included all participants who signed informed consent.

Randomized set consisted of all enrolled participants who were randomized.

Arm/Group Information

ID	Title	Description
BG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
BG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
BG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
BG003	Placebo	Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
BG004	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
	BG00053.6± 9.91 BG00155.4± 9.62 BG00253.4± 10.46 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00080 BG00165 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

American Indian or Alaskan Native

Title	Measurements
	BG0000 BG0011 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Hispanic or Latino (Yes)

Title	Measurements
	BG0000 BG0010 BG002

Height

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000163.8± 8.72 BG001165.0± 8.06 BG002

Weight

Weight data is available for 161, 163, 159 and 163 participants in each treatment arm, respectively.

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00070.79± 12.357 BG00171.21± 11.669

Body Mass Index (BMI)

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00026.30± 3.566 BG00126.16± 3.923 BG002

Smoking Classification

Number

participants

Title

Denominators

Categories

Has Never Smoked

Title	Measurements
	BG000125 BG001112 BG002

Female Reproductive Status

Number

participants

Title

Denominators

Categories

Postmenopausal

Title	Measurements
	BG00047 BG00145 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

China

Title	Measurements
	BG000129 BG001129 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 (HbA1c) at Week 26 (or Early Termination)

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 early termination relative to baseline. Negative change indicates better glycemic control.

Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. Last observation carried forward (LOCF) imputation was utilized.

Posted

Mean

Standard Deviation

percentage of glycosylated hemoglobin

Baseline and Week 26 (or Early termination)

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
OG003	Placebo	Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Units	Counts
Participants	OG000160 OG001160 OG002158 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.32± 1.067 OG001-1.23± 0.877 OG002-1.06± 0.970 OG003

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		ANCOVA		< 0.0001	An analysis of covariance (ANCOVA) model was used with treatment and country as fixed effects, and Baseline HbA1c as a continuous covariate.	Least Square Mean Difference	-0.49	Standard Error of the Mean	0.107	2-Sided	95	-0.700	-0.278				No	Superiority or Other
OG001 OG002

Secondary

Change From Baseline in HbA1c at Weeks 4, 8, 12, 16 and 20

The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 4, 8, 12, 16 and 20 relative to baseline. Negative change indicates better glycemic control.

Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. "n" in the category is the number of participants with data available at the given time-point.

Posted

Mean

Standard Deviation

percentage of glycosylated hemoglobin

Baseline and Weeks 4, 8, 12, 16 and 20

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, 16, 20 and 26

The change between the FPG value collected at Weeks 4, 8, 12, 16, 20 and 26 relative to baseline. Negative change indicates better glycemic control.

Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. "n" in the category is the number of participants with data available at the given time-point.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Weeks 4, 8, 12, 16, 20 and 26

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC

Secondary

Time to Hyperglycemic Rescue Event

Rescue is defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days of first sample: After >1 week of treatment but prior to Week 4 visit: A single FPG ≥275 mg/dL (≥15.27 mmol/L); From the Week 4 but prior to the Week 8 visit: A single FPG ≥250 mg/dL (≥13.88 mmol/L); From the Week 8 visit but prior to the Week 12 visit: A single FPG ≥225 mg/dL (≥12.49 mmol/L); From the Week 12 visit through the end-of-treatment visit (week 26): HbA1c ≥8.5% and ≤0.5% reduction in HbA1c from baseline. Time to hyperglycemic rescue was censored if the participant did not experience a hyperglycemic rescue event.

Randomized set consisted of all enrolled participants who were randomized.

Posted

Median

Inter-Quartile Range

days

From the date of randomization through Week 26

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.

Secondary

Percentage of Participants Requiring Hyperglycemic Rescue

Posted

Number

percentage of participants

Baseline up to Week 26

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.

Secondary

Percentage of Participants With Marked Hyperglycemia

Marked hyperglycemia is defined as FPG level ≥200 mg/dL (11.1 mmol/L).

Posted

Number

percentage of participants

Baseline up to Week 26

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Secondary

Change From Baseline in Body Weight at Weeks 12 and 26

Change in participant's body weight at Weeks 12 and 26 relative to baseline.

Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. "n" in the category is the number of participants with data available at the given time-point.

Posted

Median

Standard Deviation

Baseline and Weeks 12 and 26

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Secondary

Percentage of Participants With Glycosylated Hemoglobin ≤6.5%

Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤6.5%.

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Secondary

Percentage of Participants With Glycosylated Hemoglobin ≤7.0%

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Secondary

Percentage of Participants With Glycosylated Hemoglobin ≤7.5%

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Secondary

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥0.5%

Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥0.5%.

Posted

Number

percentage of participants

Baseline and Week 26

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Secondary

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.0%

Posted

Number

percentage of participants

Baseline and Week 26

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Secondary

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.5%

Posted

Number

percentage of participants

Baseline and Week 26

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Secondary

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥2.0%

Posted

Number

percentage of participants

Baseline and Week 26

ID	Title	Description
OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
OG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.	5	161	33	161
EG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.	4	162	26	162
EG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.	4	158	25	158
EG003	Placebo	Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.	5	161	35	161

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA version 18.0	Systematic Assessment		EG0000 affected161 at risk EG0011 affected162 at risk EG0020 affected158 at risk EG0030 affected161 at risk
Angina unstable	Cardiac disorders	MedDRA version 18.0	Systematic Assessment		EG0000 affected161 at risk EG0011 affected162 at risk EG0021 affected158 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA version 18.0	Systematic Assessment		EG0000 affected161 at risk EG0010 affected162 at risk EG0020 affected158 at risk EG003
Prinzmetal angina	Cardiac disorders	MedDRA version 18.0	Systematic Assessment		EG0000 affected161 at risk EG0010 affected162 at risk EG0021 affected158 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA version 18.0	Systematic Assessment		EG0001 affected161 at risk EG0010 affected162 at risk EG0020 affected158 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA version 18.0	Systematic Assessment		EG0001 affected161 at risk EG0010 affected162 at risk EG0020 affected158 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA version 18.0	Systematic Assessment		EG0000 affected161 at risk EG0010 affected162 at risk EG0021 affected158 at risk EG003
Pyrexia	General disorders	MedDRA version 18.0	Systematic Assessment		EG0000 affected161 at risk EG0011 affected162 at risk EG0020 affected158 at risk EG003
Chest discomfort	General disorders	MedDRA version 18.0	Systematic Assessment		EG0001 affected161 at risk EG0010 affected162 at risk EG0020 affected158 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA version 18.0	Systematic Assessment		EG0001 affected161 at risk EG0010 affected162 at risk EG0020 affected158 at risk EG003
Lung infection	Infections and infestations	MedDRA version 18.0	Systematic Assessment		EG0000 affected161 at risk EG0011 affected162 at risk EG0020 affected158 at risk EG003
Pneumonia	Infections and infestations	MedDRA version 18.0	Systematic Assessment		EG0000 affected161 at risk EG0010 affected162 at risk EG0020 affected158 at risk EG003
Erysipelas	Infections and infestations	MedDRA version 18.0	Systematic Assessment		EG0000 affected161 at risk EG0011 affected162 at risk EG0020 affected158 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA version 18.0	Systematic Assessment		EG0000 affected161 at risk EG0010 affected162 at risk EG0020 affected158 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA version 18.0	Systematic Assessment		EG0000 affected161 at risk EG0010 affected162 at risk EG0021 affected158 at risk EG003
Bone cyst	Musculoskeletal and connective tissue disorders	MedDRA version 18.0	Systematic Assessment		EG0000 affected161 at risk EG0010 affected162 at risk EG0021 affected158 at risk EG003
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 18.0	Systematic Assessment		EG0001 affected161 at risk EG0010 affected162 at risk EG0020 affected158 at risk EG003
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA version 18.0	Systematic Assessment	One treatment-emergent death occurred during treatment with placebo and is not related.	EG0000 affected161 at risk EG0010 affected162 at risk EG0020 affected158 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA version 18.0	Systematic Assessment	EG0005 affected161 at risk EG0014 affected162 at risk EG0021 affected158 at risk EG0034 affected161 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 18.0	Systematic Assessment	EG00011 affected161 at risk EG0018 affected162 at risk EG0028 affected158 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA version 18.0	Systematic Assessment	EG0006 affected161 at risk EG0013 affected162 at risk EG0022 affected158 at risk EG003
Protein urine present	Investigations	MedDRA version 18.0	Systematic Assessment	EG0005 affected161 at risk EG0012 affected162 at risk EG0027 affected158 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA version 18.0	Systematic Assessment	EG0006 affected161 at risk EG0019 affected162 at risk EG0027 affected158 at risk EG003

ID	Term
D003920	Diabetes Mellitus

ID	Term
C520853	alogliptin
D008687	Metformin

Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Facility	Status	City	State	ZIP	Country	Contacts
		Beijing	Beijing Municipality		China

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals