A Phase 3 Study of BMS-477118 in Combination With Metform... | NCT00327015

Label	Type	Description	Intervention Names
Saxagliptin and Metformin (A)	Experimental	PLUS open-label pioglitazone (as needed as rescue medication)	Drug: Saxagliptin Drug: Metformin Drug: pioglitazone
Saxagliptin and Metformin (B)	Experimental	PLUS open-label pioglitazone (as needed as rescue medication)	Drug: Saxagliptin Drug: Metformin Drug: pioglitazone
Saxagliptin and Placebo (C)	Experimental	PLUS open-label pioglitazone (as needed as rescue medication)	Drug: Saxagliptin Drug: Placebo Drug: pioglitazone
Metformin and Placebo (D)	Active Comparator	PLUS open-label pioglitazone (as needed as rescue medication)	Drug: Metformin Drug: Placebo Drug: pioglitazone

Name	Type	Description	Arm Group Labels	Other Names
Saxagliptin	Drug	Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)	Saxagliptin and Metformin (A) Saxagliptin and Placebo (C)

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy	Mean change from baseline in A1C at Week 24, adjusted for baseline value.	Baseline, Week 24
Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy	Mean change from baseline in A1C at Week 24, adjusted for baseline value.	Baseline, Week 24

Measure	Description	Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy	Mean change from baseline in FPG at Week 24, adjusted for baseline value.	Baseline, Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

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

Facility	Status	City	State	ZIP	Country	Contacts
East Bay Clinical Trial Center		Concord	California	94520	United States
Encompass Clinical Research

PubMed Identifier	Type	Citation	Retractions
19515181	Background	Jadzinsky M, Pfutzner A, Paz-Pacheco E, Xu Z, Allen E, Chen R; CV181-039 Investigators. Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy: a randomized controlled trial. Diabetes Obes Metab. 2009 Jun;11(6):611-22. doi: 10.1111/j.1463-1326.2009.01056.x.
32501595

ID	Title	Description
FG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.

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 Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline in A1C at Week 24, adjusted for baseline value.

Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), subjects must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, that measurement must have been taken before rescue.

Posted

Mean

Standard Error

percent

Baseline, Week 24

ID	Title	Description
OG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG001	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG002	Saxagliptin 10 mg	The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.

Units	Counts
Participants	OG000306 OG001315 OG002317

Title

Denominators

Categories

Baseline Mean

Title	Measurements
	OG0009.41± 0.072 OG0019.53± 0.069 OG0029.61± 0.075

Week 24 Mean

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline in FPG at Week 24, adjusted for baseline value.

Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.

Posted

Mean

Standard Error

mg/dL

Baseline, Week 24

ID	Title	Description
OG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG001	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG002	Saxagliptin 10 mg

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline in FPG at Week 24, adjusted for baseline value.

Posted

Mean

Standard Error

mg/dL

Baseline, Week 24

ID	Title	Description
OG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG001	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG002	Metformin

Secondary

Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.

Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.

Posted

Number

Percentage of participants

Week 24

ID	Title	Description
OG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG001	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG002

Secondary

Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.

Posted

Number

Percentage of participants

Week 24

ID	Title	Description
OG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG001	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG002

Secondary

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.

Posted

Mean

Standard Error

mg*min/dL

Baseline, Week 24

ID	Title	Description
OG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG001	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.

Primary

Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline in A1C at Week 24, adjusted for baseline value.

Posted

Mean

Standard Error

percent

Baseline, Week 24

ID	Title	Description
OG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG001	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG002	Metformin

Secondary

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value.

Posted

Mean

Standard Error

mg*min/dL

Baseline, Week 24

ID	Title	Description
OG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG001	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.

Secondary

Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.

Posted

Number

Percentage of Participants

Week 24

ID	Title	Description
OG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG001	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG002	Saxagliptin 10 mg

Secondary

Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.

Posted

Number

Percentage of participants

Week 24

ID	Title	Description
OG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG001	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG002	Metformin

Secondary

Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone.

Randomized participants who took at least 1 dose of double-blind treatment were included in the Week 24 LOCF analysis.

Posted

Number

Percentage of participants

Week 24

ID	Title	Description
OG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG001	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG002	Saxagliptin 10 mg

Secondary

Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Randomized participants who took at least 1 dose of double-blind treatment were included in the Week 24 LOCF analysis.

Posted

Number

Percentage of participants

Week 24

ID	Title	Description
OG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG001	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
OG002	Metformin

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
DIABETIC RETINOPATHY	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG0030 affected320 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
CARDIAC FAILURE	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0022 affected323 at risk EG003
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
ARTERIOSCLEROSIS CORONARY ARTERY	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
EXTREMITY NECROSIS	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
DIABETIC MACROANGIOPATHY	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
SCIATICA	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
SYNCOPE VASOVAGAL	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
CEREBRAL INFARCTION	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
FACIAL NERVE DISORDER	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
PANCREATITIS	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
HIATUS HERNIA	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
FOOD POISONING	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
GASTRIC POLYPS	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
DEAFNESS	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
SEPSIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
TETANUS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
ERYSIPELAS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
APPENDICITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
SCROTAL ABSCESS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
PHARYNGOTONSILLITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
LYMPHOPENIA	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
LYMPHADENITIS	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
ROSACEA	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
INGROWING NAIL	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
DERMATITIS ALLERGIC	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
MENOMETRORRHAGIA	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
ACQUIRED PHIMOSIS	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
UTERINE HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
ACCIDENT	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
LOWER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
OSTEOCHONDROSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
LUNG CONSOLIDATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0011 affected335 at risk EG0020 affected323 at risk EG003
PYREXIA	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
SUDDEN DEATH	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
PAPILLOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0021 affected323 at risk EG003
BILE DUCT CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
PANCREATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003
LYMPHOPROLIFERATIVE DISORDER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected328 at risk EG0010 affected335 at risk EG0020 affected323 at risk EG003

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
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
BG001	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
BG002	Saxagliptin 10 mg	The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
BG003	Metformin	The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Metformin	The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.	15	328	106	328
EG001	Saxagliptin 10 mg	The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.	16	335	106	335
EG002	Saxagliptin 10 mg + Metformin	The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.	22	323	122	323
EG003	Saxagliptin 5 mg + Metformin	The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.	16	320	116	320

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
HYPERTENSION	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG00017 affected328 at risk EG00119 affected335 at risk EG00221 affected323 at risk EG00327 affected320 at risk
HEADACHE	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00018 affected328 at risk EG00131 affected335 at risk EG00236 affected323 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00030 affected328 at risk EG00112 affected335 at risk EG00241 affected323 at risk EG003
INFLUENZA	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00019 affected328 at risk EG00117 affected335 at risk EG00213 affected323 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00019 affected328 at risk EG00124 affected335 at risk EG00219 affected323 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00025 affected328 at risk EG00123 affected335 at risk EG00222 affected323 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00010 affected328 at risk EG00114 affected335 at risk EG00219 affected323 at risk EG003