A Study Assessing Saxagliptin Treatment in Type 2 Diabeti... | NCT00295633

Official Title

A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone

Status Module

Description 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
Saxagliptin plus open-label TZD (A)	Experimental	Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)	Drug: Saxagliptin Drug: pioglitazone Drug: rosiglitazone Drug: metformin
Saxagliptin plus open-label TZD (B)	Experimental	Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)	Drug: Saxagliptin Drug: pioglitazone Drug: rosiglitazone Drug: metformin
Placebo plus open-label TZD (C)	Placebo Comparator	Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)	Drug: Placebo Drug: pioglitazone Drug: rosiglitazone Drug: metformin

Name	Type	Description	Arm Group Labels	Other Names
Saxagliptin	Drug	Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT)	Saxagliptin plus open-label TZD (A)

Outcomes Module

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

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Mean change from baseline in FPG at Week 24, adjusted for baseline value.	Baseline, Week 24
Percentage of Participants Achieving A1c <7% at Week 24

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Winston Technology, Inc.		Haleyville	Alabama	35565	United States
Sunbelt Research Group, Llc

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19864452	Background	Hollander P, Li J, Allen E, Chen R; CV181-013 Investigators. Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone. J Clin Endocrinol Metab. 2009 Dec;94(12):4810-9. doi: 10.1210/jc.2009-0550. Epub 2009 Oct 28.
27402391	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Saxagliptin 2.5 mg Plus Open-label Thiazolidinedione (TZD)	The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Saxagliptin 2.5 mg Plus Open-label TZD	The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
BG001	Saxagliptin 5 mg Plus Open-label TZD	The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
BG002	Placebo Plus Open-label TZD	The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
BG003	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

Baseline Mean

Title	Measurements
	OG0008.25± 0.080 OG0018.35± 0.080 OG0028.19± 0.080

Week 24 Mean

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

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 2.5 mg Plus Open-label TZD	The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
OG001	Saxagliptin 5 mg Plus Open-label TZD	The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
OG002	Placebo Plus Open-label TZD

Secondary

Percentage of Participants Achieving A1c <7% at Week 24

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

Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, subjects 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 2.5 mg Plus Open-label TZD	The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
OG001	Saxagliptin 5 mg Plus Open-label TZD	The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
OG002	Placebo Plus Open-label TZD

Secondary

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

Mean change from baseline for 0 to 180 minutes PPG AUC achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.

Posted

Mean

Standard Error

mg*min/dL

Baseline, Week 24

ID	Title	Description
OG000	Saxagliptin 2.5 mg Plus Open-label TZD	The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
OG001	Saxagliptin 5 mg Plus Open-label TZD	The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.

Arm/Groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PLA + TZD	20	184	109	184
EG001	SAXA 2.5MG + TZD	19	195	107	195
EG002	SAXA 5MG + TZD	18	186	109	186

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
CATARACT	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
BLOOD PRESSURE INCREASED	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
HYPERTENSION	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
ANXIETY	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
ALCOHOL ABUSE	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected195 at risk EG0020 affected186 at risk
CEREBRAL HAEMATOMA	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
CEREBELLAR HAEMORRHAGE	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
VOMITING	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
ANAL FISTULA	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected195 at risk EG0021 affected186 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
IRRITABLE BOWEL SYNDROME	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
ORCHITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
PNEUMONIA	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
ANAL ABSCESS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
APPENDICITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0012 affected195 at risk EG0021 affected186 at risk
MENINGITIS ASEPTIC	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
RENAL CYST	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
CALCULUS BLADDER	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
CALCULUS URETERIC	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
HYPOVOLAEMIA	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
ENDOMETRIOSIS	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
PROSTATOMEGALY	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
POSTMENOPAUSAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
BACK INJURY	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
FIBULA FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0021 affected186 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
PYREXIA	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
CHEST PAIN	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0011 affected195 at risk EG0021 affected186 at risk
SUDDEN DEATH	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
COLON NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0011 affected195 at risk EG0020 affected186 at risk
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected184 at risk EG0010 affected195 at risk EG0020 affected186 at risk
METASTATIC SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected184 at risk EG0010 affected195 at risk EG0021 affected186 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
HYPERTENSION	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG00012 affected184 at risk EG00115 affected195 at risk EG00211 affected186 at risk
HEADACHE	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00012 affected184 at risk EG00115 affected195 at risk EG00215 affected186 at risk
DIZZINESS	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00014 affected184 at risk EG00110 affected195 at risk EG0027 affected186 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00013 affected184 at risk EG0018 affected195 at risk EG00210 affected186 at risk
BRONCHITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0009 affected184 at risk EG00111 affected195 at risk EG0027 affected186 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00015 affected184 at risk EG0019 affected195 at risk EG00215 affected186 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00017 affected184 at risk EG00123 affected195 at risk EG00220 affected186 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00019 affected184 at risk EG00125 affected195 at risk EG00224 affected186 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected184 at risk EG0013 affected195 at risk EG00211 affected186 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected184 at risk EG00112 affected195 at risk EG00212 affected186 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00013 affected184 at risk EG00122 affected195 at risk EG00210 affected186 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected184 at risk EG00110 affected195 at risk EG00212 affected186 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG00013 affected184 at risk EG0019 affected195 at risk EG0025 affected186 at risk
PYREXIA	General disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected184 at risk EG0016 affected195 at risk EG00211 affected186 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 11.1	Systematic Assessment	EG00019 affected184 at risk EG0019 affected195 at risk EG00226 affected186 at risk

Ancestor Terms

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001645	Biguanides
D006146	Guanidines
D000578	Amidines

The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
C502994	saxagliptin
D000077205	Pioglitazone
D000077154	Rosiglitazone
D008687	Metformin