Bioequivalence Study of Saxagliptin and Glucophage Combin... | NCT00899470

Bioequivalence Study of Saxagliptin and Glucophage Combin... | NCT00899470 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
S+ M, (fasted)> S/M (fed)> S/M (fasted)>S+M (fed)	Experimental	Participants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M [fasted]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/M [fed]) followed by S/M under fasting conditions (S/M [fasted]) followed by S + M under fed conditions (S + M [fed])	Drug: Co-administration of Saxagliptin and Metformin IR, Fasted Drug: Saxagliptin/Metformin, Fasting Drug: Co-administration of Saxagliptin and Metformin IR, Fed Drug: Saxagliptin/Metformin, Fed
S/M (fasted)> S+M (fasted)> S+M (fed)> S/M (fed)	Experimental	Participants were randomized to receive S/M (fasted) followed by S + M (fasted) followed by S + M (fed) followed by S/M (fed)	Drug: Co-administration of Saxagliptin and Metformin IR, Fasted Drug: Saxagliptin/Metformin, Fasting Drug: Co-administration of Saxagliptin and Metformin IR, Fed Drug: Saxagliptin/Metformin, Fed
S+M (fed)> S/M (fasted) >S/M (fed)> S+M (fasted)	Experimental	Participants were randomized to receive S + M (fed) followed by S/M (fasted) followed by S/M (fed) followed by S+M (fasted)	Drug: Co-administration of Saxagliptin and Metformin IR, Fasted Drug: Saxagliptin/Metformin, Fasting Drug: Co-administration of Saxagliptin and Metformin IR, Fed Drug: Saxagliptin/Metformin, Fed
S/M (fed)> S+M (fed)> S+M (fasted)> S/M (fasted)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Co-administration of Saxagliptin and Metformin IR, Fasted	Drug	Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Saxagliptin Mean Maximum Observed Plasma Concentration (Cmax)	Cmax of single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.	Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Time of Last Quantifiable Concentration (AUC [0-T]}	AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.	Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Infinity (AUC [0-INF])	AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.	Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Saxagliptin Mean Plasma Half-life (T-half) and Mean Time of Maximum Observed Plasma Concentration (T-max)	T-half and T-max for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg) or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.	Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Metformin Mean Cmax	Cmax of single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.

Secondary Outcomes

Measure	Description	Time Frame
BMS-510849 Mean Cmax	Cmax of the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administered as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.	Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mds Pharma Services		Lincoln	Nebraska	68502	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23549864	Derived	Upreti VV, Keung CF, Boulton DW, Chang M, Li L, Tang A, Hsiang BC, Quamina-Edghill D, Frevert EU, Lacreta FP. Bioequivalence of saxagliptin/metformin immediate release (IR) fixed-dose combination tablets and single-component saxagliptin and metformin IR tablets in healthy adult subjects. Clin Drug Investig. 2013 May;33(5):365-74. doi: 10.1007/s40261-013-0075-z.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	S+M (Fasted)> S/M (Fed)> S/M (Fasted)>S+M (Fed)	Participants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M [fasted]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/M [fed]) followed by S/M under fasting conditions (S/M [fasted]) followed by S + M under fed conditions (S + M [fed])

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

First Washout Period

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
COMPLETED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects

Second Therapy

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
COMPLETED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects

Second Washout

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
COMPLETED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects

Third Therapy

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
COMPLETED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects

Third Washout

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
COMPLETED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects

Fourth Therapy

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
COMPLETED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects

Arm/Group Information

ID	Title	Description
BG000	All Treated Participants	Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.

Units	Counts
Participants	BG00024

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
	BG00028± 7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0007
Male	BG00017

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

Saxagliptin Mean Maximum Observed Plasma Concentration (Cmax)

Cmax of single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.

PK data set, all participants who received study drug

Posted

Mean

Standard Deviation

ng/mL

Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
OG003	Saxagliptin/Metformin FDC (Fed)	Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions

Units	Counts
Participants	OG00024 OG00124 OG00224 OG003

Title

Denominators

Categories

Title	Measurements
	OG0008.57± 2.572 OG0018.61± 2.266 OG00211.36± 2.875 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 OG001	To demonstrate bioequivalence (BE) of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.	Mixed Models Analysis	Bioequivalence=90% confidence intervals (CIs) for the test			Geometric Mean Ratio, Test vs. Reference	1.011			2-Sided	90	0.940	1.088			For Cmax of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state

Primary

Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Time of Last Quantifiable Concentration (AUC [0-T]}

AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.

PK data set, all participants who received study drug

Posted

Mean

Standard Deviation

ng*h/mL

Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions

Primary

Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Infinity (AUC [0-INF])

AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.

PK data set, all participants who received study drug

Posted

Mean

Standard Deviation

ng*h/mL

Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions

Primary

Saxagliptin Mean Plasma Half-life (T-half) and Mean Time of Maximum Observed Plasma Concentration (T-max)

T-half and T-max for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg) or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.

PK data set, all participants who received study drug

Posted

Mean

Standard Deviation

hours

Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions

Primary

Metformin Mean Cmax

Cmax of single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.

PK data set, all participants who received study drug

Posted

Mean

Standard Deviation

ng/mL

Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
OG003

Primary

Metformin Mean AUC (0-T)

AUC (0-T for single-dose metformin (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.

PK data set, all participants who received study drug

Posted

Mean

Standard Deviation

ng*h/mL

Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
OG003

Primary

Metformin Mean AUC(0-INF)

AUC (0-INF) for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.

PK data set, all participants who received study drug

Posted

Mean

Standard Deviation

ng*h/mL

Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
OG003

Primary

Metformin T-half and T-max

T-half and T-max for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg), or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.

PK data set, all participants who received study drug

Posted

Mean

Standard Deviation

hours

Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
OG003

Secondary

BMS-510849 Mean Cmax

Cmax of the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administered as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.

PK data set, all participants who received study drug

Posted

Mean

Standard Deviation

ng/mL

Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions

Secondary

BMS-510849 Mean AUC (0-T)

AUC (0-T) for the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administration as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.

PK data set, all participants who received study drug

Posted

Mean

Standard Deviation

ng*h/mL

Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions

Secondary

BMS-510849 Mean AUC (0-INF)

AUC (0-T)= for the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administered as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.

PK data set, all participants who received study drug

Posted

Mean

Standard Deviation

ng*h/mL

Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions

Secondary

BMS-510849 Mean T-half and T-max

T-half and Tmax of the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administerd as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.

PK data set, all participants who received study drug

Posted

Mean

Standard Deviation

hours

Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions

Secondary

Number of Participants With at Least 1 Adverse Event (AE), Death, Serious AE (SAE), or AEs Leading to Discontinuation

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.

All Treated Participants

Posted

Number

participants

From Day 1 through Day 45, including up to 56 days after last dose of study medication

ID	Title	Description
OG000	Co-administration of Saxagliptin and Metformin IR (Fasted)	Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin (Fasted)	Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Co-administration of Saxagliptin and Metformin IR (Fed)

Secondary

Number of Participants With Laboratory Marked Abnormalities

High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Leukocytes: <0.9 x LLN/ >1.2 x ULN; blood urea nitrogen (BUN): >1.1 x ULN; creatinine: >1.33 x BL; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN; creatinine kinase (CK): >1.5 x ULN; urine blood=use ≥2 x BL if value ≥2+ or BL1+

All Treated Participants

Posted

Number

participants

From Day 1 through Day 45, including up to 56 days after last dose of study medication

ID	Title	Description
OG000	Co-administration of Saxagliptin and Metformin IR (Fasted)	Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin (Fasted)	Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Co-administration of Saxagliptin and Metformin IR (Fed)	Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions

Secondary

Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities

PR interval, QRS complex, width of QRS, QT interval, and QT corrected for heart rate adjusting for heart rate using either Bazett formula or Fridericia formula were measured. ECG abnormalities were judged to be of medical importance by the Investigator.

All Treated Participants

Posted

Number

participants

Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions

Secondary

Number of Participants With Clinically Relevant Vital Sign Abnormalities

Mean systolic and diastolic blood pressure, heart rate, respiration, and temperature were assessed.Vital sign abnormalities abnormalities were judged to be of medical importance by the Investigator.

All Treated Participants

Posted

Number

participants

Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
OG003

Secondary

Number of Participant With Clinically Relevant Physical Examination Abnormalities

A physical examination was conducted which included height and weight measurements, from which the Body Mass Index was determined. Physical examination abnormalities were judged to be of medical importance by the Investigator.

All Treated Participants

Posted

Number

participants

Screen, Period 1 Day -1, prior to discharge

ID	Title	Description
OG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
OG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
OG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
OG003

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Coadministration of Saxagliptin and Metformin IR (Fasted)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions	24	6	24
EG001	Saxagliptin/Metformin FDC (Fasted)	Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions	24	3	24
EG002	Coadministration of Saxagliptin and Metformin IR (Fed)	Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions	24	4	24
EG003	Saxagliptin/Metformin FDC (Fed)	Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions	24	1	24

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
PALPITATIONS	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG0030 affected24 at risk
HEADACHE	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected24 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected24 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
GASTROINTESTINAL PAIN	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
EAR PAIN	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
LYMPH NODE PAIN	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected24 at risk EG0011 affected24 at risk EG0021 affected24 at risk EG003
INCREASED UPPER AIRWAY SECRETION	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
FATIGUE	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected24 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003

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	To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted and fed states, linear mixed model analysis was performed on log[AUC(0-T)] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.	Mixed Models Analysis	Bioequivalence=90% CIs for the test			Geometric Mean Ratio, Test vs. Reference	1.029			2-Sided	90	0.993	1.066			For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state	Yes	Non-Inferiority or Equivalence	If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.
OG002 OG003	To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log[AUC(0-T)] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.	Mixed Models Analysis	Bioequivalence=90% CIs for the test			Geometric Means Ratio	1.021			2-Sided	90	0.986	1.058			For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state	Yes	Non-Inferiority or Equivalence	If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.

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	To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log[AUC(INF)] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.	Mixed Models Analysis	Bioequivalence=90% CIs for the test			Geometric Mean Ratio, Test vs. Reference	1.027			2-Sided	90	0.990	1.066			For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state	Yes	Non-Inferiority or Equivalence	If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.
OG002 OG003	To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log[AUC(INF)] of saxagliptin and metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.	Mixed Models Analysis	Bioequivalence=90% CIs for the test			Geometric Means Ratio Test vs. Reference	1.022			2-Sided	95	0.985	1.060			For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state	Yes	Non-Inferiority or Equivalence	If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.

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	To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.	Mixed Models Analysis	Bioequivalence=90% CIs for the test			Geometric Mean Ratio, Test vs. Reference	1.009			2-Sided	90	0.939	1.084			For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted fed state	Yes	Non-Inferiority or Equivalence	If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted and fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin, respectively.
OG002 OG003	To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.	Mixed Models Analysis	Bioequivalence=90% CIs for the test			Geometric Mean Ratio, Test vs. Reference	1.034			2-Sided	90	0.962	1.111			For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state	Yes	Non-Inferiority or Equivalence	If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin.

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	To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log[AUC(0-T)] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.	Mixed Models Analysis	Bioequivalence=90% CIs for the test			Geometric Mean Ratio, Test vs. Reference	1.024			2-Sided	90	0.964	1.088			For AUC(0-T) of metformin the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state	Yes	Non-Inferiority or Equivalence	If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.
OG002 OG003	To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log[AUC(0-T)] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.	Mixed Models Analysis	Bioequivalence=90% CIs for the test			Geometric Mean Ratio, Test vs. Reference	1.042			2-Sided	90	0.981	1.108			For AUC(0-T) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state	Yes	Non-Inferiority or Equivalence	If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.

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	To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log[AUC(INF)] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.	Mixed Models Analysis	Bioequivalence=90% CIs for the test			Geometric Mean Ratio, Test vs. Reference	1.029			2-Sided	90	0.973	1.088			For AUC(INF) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state	Yes	Non-Inferiority or Equivalence	If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted ), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.
OG002 OG003	To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log[AUC(INF)] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.	Mixed Models Analysis	Bioequivalence=90% CIs for the test			Geometric Mean Ratio, Test vs. Reference	1.042			2-Sided	90	0.986	1.102			For AUC(INF) of metformin, the point estimate and 90% confidence interval (CI) were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state	Yes	Non-Inferiority or Equivalence	If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.

Title

Denominators

Categories

Participants with at least 1 AE

Title	Measurements
	OG0006 OG0013 OG0024 OG0031 OG0047

Death

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SAE

Title	Measurements
	OG0000 OG0010 OG0020 OG003

AE leading to discontinuation

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Title

Denominators

Categories

High leukocytes

Title	Measurements
	OG0000 OG0010 OG0021 OG0030 OG0041

High BUN

Title	Measurements
	OG0000 OG0011 OG0020 OG003

High creatinine

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Low phosphorus

Title	Measurements
	OG0000 OG0011 OG0020 OG003

High CK

Title	Measurements
	OG0000 OG0010 OG0021 OG003

High urine blood

Title	Measurements
	OG0000 OG0011 OG0020 OG003

ID	Term
D003920	Diabetes Mellitus
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