A Study of Saxagliptin in Subjects With Type 2 Diabetes W... | NCT00313313

Official Title

A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide 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 2.5 mg + Glyburide 7.5 mg (A)	Experimental	Metformin 500-2500 mg (as needed)	Drug: Saxagliptin Drug: Glyburide Drug: Metformin
Saxagliptin 5 mg + Glyburide 7.5 mg (B)	Experimental	Metformin 500-2500 mg (as needed)	Drug: Saxagliptin Drug: Glyburide Drug: Metformin
Placebo + Glyburide 7.5 mg (C)	Placebo Comparator	Metformin 500-2500 mg (as needed)	Drug: Placebo Drug: Glyburide Drug: Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Saxagliptin	Drug	Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT])	Saxagliptin 2.5 mg + Glyburide 7.5 mg (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

Facility	Status	City	State	ZIP	Country	Contacts
Reserach Solutions, Llc		Jonesboro	Arkansas	72401	United States
Searcy Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19614786	Background	Chacra AR, Tan GH, Apanovitch A, Ravichandran S, List J, Chen R; CV181-040 Investigators. Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomised controlled trial. Int J Clin Pract. 2009 Sep;63(9):1395-406. doi: 10.1111/j.1742-1241.2009.02143.x. Epub 2009 Jul 15.
27402391

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Saxagliptin 2.5 mg + Glyburide 7.5 mg	The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.

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

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

Arm/Group Information

ID	Title	Description
BG000	Saxagliptin 2.5 mg + Glyburide 7.5 mg	The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
BG001	Saxagliptin 5 mg + Glyburide 7.5 mg	The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
BG002	Placebo + Glyburide 7.5 mg	The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
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
	OG0008.36± 0.057 OG0018.48± 0.056 OG0028.44± 0.055

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 + Glyburide 7.5 mg	The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
OG001	Saxagliptin 5 mg + Glyburide 7.5 mg	The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
OG002

Secondary

Percentage of Participants Achieving A1C < 7% 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 2.5 mg + Glyburide 7.5 mg	The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
OG001	Saxagliptin 5 mg + Glyburide 7.5 mg	The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.

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 at Week 24, adjusted for baseline values.

Posted

Mean

Standard Error

mg*min/dL

Baseline, Week 24

ID	Title	Description
OG000	Saxagliptin 2.5 mg + Glyburide 7.5 mg	The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
OG001	Saxagliptin 5 mg + Glyburide 7.5 mg	The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo + Glyburide 7.5 mg	The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.	23	267	163	267
EG001	Saxagliptin 2.5 mg + Glyburide 7.5 mg	The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.	18	248	144	248
EG002	Saxagliptin 5 mg + Glyburide 7.5 mg	The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.	12	253	154	253

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANGINA PECTORIS	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0010 affected248 at risk EG0021 affected253 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0012 affected248 at risk EG0020 affected253 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0011 affected248 at risk EG0020 affected253 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected267 at risk EG0011 affected248 at risk EG0021 affected253 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0010 affected248 at risk EG0021 affected253 at risk
EXTREMITY NECROSIS	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0010 affected248 at risk EG0021 affected253 at risk
PERIPHERAL VASCULAR DISORDER	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0010 affected248 at risk EG0021 affected253 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0010 affected248 at risk EG0022 affected253 at risk
SYNCOPE	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0011 affected248 at risk EG0020 affected253 at risk
ASCITES	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0011 affected248 at risk EG0020 affected253 at risk
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0011 affected248 at risk EG0020 affected253 at risk
SALIVARY GLAND MASS	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0010 affected248 at risk EG0021 affected253 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0011 affected248 at risk EG0021 affected253 at risk
PNEUMONIA	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
APPENDICITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0012 affected248 at risk EG0020 affected253 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
VIRAL INFECTION	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0011 affected248 at risk EG0020 affected253 at risk
WOUND INFECTION	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
CELLULITIS ORBITAL	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0010 affected248 at risk EG0021 affected253 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0011 affected248 at risk EG0021 affected253 at risk
LOWER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0011 affected248 at risk EG0020 affected253 at risk
POST-TRAUMATIC PAIN	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0011 affected248 at risk EG0020 affected253 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0010 affected248 at risk EG0021 affected253 at risk
GASTROINTESTINAL INJURY	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0010 affected248 at risk EG0021 affected253 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0010 affected248 at risk EG0021 affected253 at risk
BRONCHITIS CHRONIC	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0011 affected248 at risk EG0020 affected253 at risk
ASTHENIA	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0011 affected248 at risk EG0020 affected253 at risk
CHEST PAIN	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0012 affected248 at risk EG0020 affected253 at risk
SUDDEN CARDIAC DEATH	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
ADENOMA BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0011 affected248 at risk EG0020 affected253 at risk
GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0011 affected248 at risk EG0020 affected253 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0011 affected248 at risk EG0020 affected253 at risk
THYROID NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected267 at risk EG0010 affected248 at risk EG0020 affected253 at risk
MYELODYSPLASTIC SYNDROME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected267 at risk EG0010 affected248 at risk EG0021 affected253 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
HYPERTENSION	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG00015 affected267 at risk EG00115 affected248 at risk EG00223 affected253 at risk
HEADACHE	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00023 affected267 at risk EG00123 affected248 at risk EG00225 affected253 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00027 affected267 at risk EG00122 affected248 at risk EG00216 affected253 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected267 at risk EG00113 affected248 at risk EG00210 affected253 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0009 affected267 at risk EG00113 affected248 at risk EG0028 affected253 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected267 at risk EG00116 affected248 at risk EG0027 affected253 at risk
INFLUENZA	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00027 affected267 at risk EG00121 affected248 at risk EG00219 affected253 at risk
PHARYNGITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00015 affected267 at risk EG00111 affected248 at risk EG00219 affected253 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00029 affected267 at risk EG00121 affected248 at risk EG00226 affected253 at risk
PHARYNGOTONSILLITIS	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00011 affected267 at risk EG00113 affected248 at risk EG0025 affected253 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00032 affected267 at risk EG00133 affected248 at risk EG00242 affected253 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00025 affected267 at risk EG00117 affected248 at risk EG00224 affected253 at risk
DYSLIPIDAEMIA	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG00012 affected267 at risk EG00111 affected248 at risk EG00213 affected253 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00018 affected267 at risk EG00118 affected248 at risk EG00216 affected253 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00020 affected267 at risk EG00118 affected248 at risk EG00220 affected253 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00019 affected267 at risk EG00114 affected248 at risk EG00215 affected253 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG00017 affected267 at risk EG00119 affected248 at risk EG00215 affected253 at risk

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

ID	Term
D013453	Sulfonylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457	Sulfur Compounds
D001645	Biguanides
D006146	Guanidines
D000578	Amidines