Efficacy and Safety of Dapagliflozin in Combination With... | NCT00660907

Status Module

Name	Class
Bristol-Myers Squibb	INDUSTRY

Label	Type	Description	Intervention Names
1	Experimental	dapagliflozin plus metformin	Drug: dapagliflozin Drug: metformin hydrochloride
2	Active Comparator	glipizide plus metformin	Drug: glipizide Drug: metformin hydrochloride

Name	Type	Description	Arm Group Labels	Other Names
dapagliflozin	Drug	Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks	1

Measure	Description	Time Frame
Adjusted Mean Change in HbA1c Levels	To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.	Baseline to Week 52

Measure	Description	Time Frame
Adjusted Mean Change in Body Weight	To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.	Baseline to Week 52
Proportion of Participants With at Least One Episode of Hypoglycemia

Name	Affiliation	Role
Michael A. Nauck, Prof. Dr. med.	Diabeteszentrum Bad Lauterberg, Germany	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Buenos Aires			Argentina
Research Site

PubMed Identifier	Type	Citation	Retractions
21816980	Result	Nauck MA, Del Prato S, Meier JJ, Duran-Garcia S, Rohwedder K, Elze M, Parikh SJ. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011 Sep;34(9):2015-22. doi: 10.2337/dc11-0606. Epub 2011 Aug 4.
23529570

Label	URL
CSR-D1690C00004.pdf	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Dapagliflozin Plus Metformin	Experimental dapagliflozin plus metformin
FG001	Glipizide Plus Metformin	Active Comparator glipizide plus metformin

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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
	BG00058.1± 9.37 BG00158.6± 9.80 BG00258.4± 9.58

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000179 BG001181 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0010 BG002

BMI

Mean

Standard Deviation

kg/m2

Title

Denominators

Categories

Title	Measurements
	BG00031.71± 5.104 BG00131.23± 5.053 BG002

HbA1c

Mean

Standard Deviation

percent

Title

Denominators

Categories

Title	Measurements
	BG0007.69± 0.855 BG0017.74± 0.886 BG002

FPG

Mean

Standard Deviation

ng/mL

Title

Denominators

Categories

Title	Measurements
	BG000162.24± 37.796 BG001163.91± 41.559 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Adjusted Mean Change in HbA1c Levels

To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.

Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values

Posted

Least Squares Mean

95% Confidence Interval

percent

Baseline to Week 52

ID	Title	Description
OG000	Dapagliflozin Plus Metformin	Experimental dapagliflozin plus metformin
OG001	Glipizide Plus Metformin	Active Comparator glipizide plus metformin

Units	Counts
Participants	OG000400 OG001401

Title

Denominators

Categories

Title	Measurements
	OG000-0.52(-0.60 to -0.44) OG001-0.52(-0.60 to -0.44)

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	The null hypothesis is given as H0: mean(treat) minus mean(reference) >= delta versus the alternative HA: mean(treat) minus mean(reference) < delta (with alpha = 0.025, one-sided)	ANCOVA	with treatment group as effect and baseline value as covariate	<0.0001	Significant at alpha=0.025 (1-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives	Mean Difference (Final Values)	0.00	Standard Error of the Mean	0.0569	2-Sided	95	-0.11	0.11				Yes

Secondary

Adjusted Mean Change in Body Weight

To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.

Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values

Posted

Least Squares Mean

95% Confidence Interval

Baseline to Week 52

ID	Title	Description
OG000	Dapagliflozin Plus Metformin	Experimental dapagliflozin plus metformin
OG001	Glipizide Plus Metformin	Active Comparator glipizide plus metformin

Units	Counts
Participants	OG000

Secondary

Proportion of Participants With at Least One Episode of Hypoglycemia

To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.

Full analysis set

Posted

Least Squares Mean

95% Confidence Interval

Percentage of participants

Baseline to Week 52

ID	Title	Description
OG000	Dapagliflozin Plus Metformin	Experimental dapagliflozin plus metformin
OG001	Glipizide Plus Metformin	Active Comparator glipizide plus metformin

Units	Counts
Participants	OG000

Secondary

Proportion of Participants With Body Weight Reduction of at Least 5%

To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value.

Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values

Posted

Least Squares Mean

95% Confidence Interval

Percentage of participants

Baseline to Week 52

ID	Title	Description
OG000	Dapagliflozin Plus Metformin	Experimental dapagliflozin plus metformin
OG001	Glipizide Plus Metformin	Active Comparator glipizide plus metformin

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0012 affected408 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0013 affected408 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Angina Pectoris	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0011 affected408 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Bradycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Cardiac Failure	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0011 affected408 at risk
Left Ventricular Failure	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Ventricular Arrhythmia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Cataract	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Retinal Detachment	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0011 affected408 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Anal Fissure	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Chest Pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Sudden Death	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Hepatic Cirrhosis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Diverticulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0012 affected408 at risk
Bronchitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0011 affected408 at risk
Erysipelas	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Liver Abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Pneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0011 affected408 at risk
Pyelonephritis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Septic Shock	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0012 affected408 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0011 affected408 at risk
Clavicle Fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Multiple Injuries	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Postoperative Renal Failure	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Creatinine Renal Clearance Decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0013 affected408 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0003 affected406 at risk EG0011 affected408 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Bronchial Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Cerebral Thrombosis	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Cervicobrachial Syndrome	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Loss Of Consciousness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Migraine	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Depression Suicidal	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Obsessive-Compulsive Disorder	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Diabetic Nephropathy	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Uterine Prolapse	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected406 at risk EG0010 affected408 at risk
Alveolitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected406 at risk EG0011 affected408 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG0010 affected408 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00019 affected406 at risk EG00126 affected408 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00043 affected406 at risk EG00161 affected408 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00024 affected406 at risk EG00131 affected408 at risk
Influenza	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00030 affected406 at risk EG00130 affected408 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00030 affected406 at risk EG00117 affected408 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG00011 affected406 at risk EG00121 affected408 at risk
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00015 affected406 at risk EG00137 affected408 at risk
Tremor	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected406 at risk EG00131 affected408 at risk
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00021 affected406 at risk EG00117 affected408 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected406 at risk EG00127 affected408 at risk
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG00030 affected406 at risk EG00135 affected408 at risk
Hypoglycemia	Endocrine disorders	MedDRA 12.1	Systematic Assessment	EG00014 affected406 at risk EG001162 affected408 at risk

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

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

ID	Title	Description
BG000	Dapagliflozin Plus Metformin	Experimental dapagliflozin plus metformin
BG001	Glipizide Plus Metformin	Active Comparator glipizide plus metformin
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dapagliflozin Plus Metformin	Experimental dapagliflozin plus metformin			35	406	163	406
EG001	Glipizide Plus Metformin	Active Comparator glipizide plus metformin			46	408	260	408