Efficacy and Safety in Patients With Type 2 Diabetes Mell... | NCT01042977

Official Title

A 24-week, Multicentre, Randomised, Double-blind,Age-stratified, Placebo Controlled Phase III Study With an 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Patients With T2DM and Cardiovascular Disease, Who Exhibit Inadequate Glycaemic Control on Usual Care

Status Module

Name	Class
Bristol-Myers Squibb	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental	dapagliflozin 10 mg tablet	Drug: Dapagliflozin
2	Placebo Comparator	matching placebo tablet	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin	Drug	10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adjusted Mean Change in HbA1c Levels	To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease, measured as the mean change in HbA1c from baseline to week 24.	Baseline to Week 24
Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit	To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.	Baseline to Week 24

Secondary Outcomes

Measure	Description	Time Frame
Adjusted Mean Percent Change in Body Weight	To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.	Baseline to Week 24
Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Dr. Lawrence A Leiter, MD	Division of Endocrinology & Metabolism, St Michael's Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama		United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38770818	Derived	Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Dapagliflozin	Dapagliflozin 10 mg plus usual care
FG001	Placebo	Placebo plus usual care

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Full Analysis Set defined as all randomized participants (as randomized) who received at least one dose of double-blind study medication, who have a non-missing baseline value and at least one post-baseline efficacy value for at least one efficacy variable during double-blind treatment period.

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
	BG00063.9± 7.60 BG00163.6± 7.02 BG00263.8± 7.31

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000159 BG001159 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000454 BG001449 BG002

HbA1c

Mean

Standard Deviation

Percent

Title

Denominators

Categories

Title	Measurements
	BG0008.04± 0.759 BG0018.08± 0.795 BG002

Body weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00094.53± 17.804 BG00193.23± 16.842 BG002

Systolic Blood Pressure

Mean

Standard Deviation

mmHg

Title

Denominators

Categories

Title	Measurements
	BG000134.9± 14.53 BG001134.6± 13.96 BG002

Number of participants with BMI >= 27 kg/m2 at baseline

Number

Participants

Title

Denominators

Categories

< 25 kg/m²

Title	Measurements
	BG00015 BG00131 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 compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease, measured as the mean change in HbA1c from baseline to week 24.

Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values

Posted

Least Squares Mean

95% Confidence Interval

Percent

Baseline to Week 24

ID	Title	Description
OG000	Dapagliflozin	Dapagliflozin 10 mg plus usual care
OG001	Placebo	Placebo plus usual care

Units	Counts
Participants	OG000474 OG001471

Title

Denominators

Categories

Title	Measurements
	OG000-0.33± 0.0434(-0.42 to -0.25) OG0010.07(-0.02 to 0.15)

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	H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0	ANCOVA	with treatment group and stratum as effects and baseline value as covariate for each endpoint	<0.0001	Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives	Mean Difference (Final Values)	-0.40	Standard Error of the Mean	0.0489	2-Sided	95	-0.50	-0.30			with stratum = age-by-insulin use-by-time from most recent qualifying CV event	No

Primary

Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit

To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.

Full Analysis Set, subjects with non-missing baseline and Week 24 (LOCF) values

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline to Week 24

ID	Title	Description
OG000	Dapagliflozin	Dapagliflozin 10 mg plus usual care
OG001	Placebo	Placebo plus usual care

Units	Counts
Participants	OG000

Secondary

Adjusted Mean Percent Change in Body Weight

To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.

Full Analysis Set, subjects with non-missing baseline and Week 24 (LOCF) values

Posted

Least Squares Mean

95% Confidence Interval

Percentage of Body Weight

Baseline to Week 24

ID	Title	Description
OG000	Dapagliflozin	Dapagliflozin 10 mg plus usual care
OG001	Placebo	Placebo plus usual care

Units	Counts
Participants	OG000

Secondary

Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²

To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.

Full Analysis Set, subjects with baseline BMI ≥27 kg/m2 and Week 24 (LOCF) values

Posted

Least Squares Mean

95% Confidence Interval

Percentage of participants

Baseline to Week 24

ID	Title	Description
OG000	Dapagliflozin	Dapagliflozin 10 mg plus usual care
OG001	Placebo	Placebo plus usual care

Units	Counts
Participants	OG000

Secondary

Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF)

To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.

Full Analysis Set, subjects with non-missing baseline and Week 8 (LOCF) values

Posted

Least Squares Mean

95% Confidence Interval

mmHg

Baseline to Week 8

ID	Title	Description
OG000	Dapagliflozin	Dapagliflozin 10 mg plus usual care
OG001	Placebo	Placebo plus usual care

Units	Counts
Participants	OG000

Secondary

Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF)

To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.

Full Analysis set, subjects with non-missing baseline and Week 24 (LOCF) values

Posted

Least Squares Mean

95% Confidence Interval

mmHg

Baseline to Week 24

ID	Title	Description
OG000	Dapagliflozin	Dapagliflozin 10 mg plus usual care
OG001	Placebo	Placebo plus usual care

Units	Counts
Participants	OG000

Secondary

Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg

To compare the mean change in seated systolic blood pressure (SBP) in participants with baseline seated SBP ≥130 mmHg achieved with dapagliflozin versus placebo from baseline to week 8.

Full Analysis set, participants with baseline seated SBP ≥130 mmHg and Week 8 (LOCF) value

Posted

Least Squares Mean

95% Confidence Interval

mmHg

Baseline to Week 8

ID	Title	Description
OG000	Dapagliflozin	Dapagliflozin 10 mg plus usual care
OG001	Placebo	Placebo plus usual care

Units	Counts
Participants	OG000

Arm/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	Dapagliflozin 10 mg plus usual care			41	482	147	482
EG001	Placebo	Placebo plus usual care			46	483	134	483

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected482 at risk EG0012 affected483 at risk
Myocardial infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected482 at risk EG0011 affected483 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected482 at risk EG0010 affected483 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected482 at risk EG0013 affected483 at risk
Angina pectoris	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0011 affected483 at risk
Cardiac failure	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0011 affected483 at risk
Coronary artery disease	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0011 affected483 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected482 at risk EG0010 affected483 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0011 affected483 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0011 affected483 at risk
Spinal cord compression	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Syncope	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0011 affected483 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0012 affected483 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk
Respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected482 at risk EG0011 affected483 at risk
Bronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Osteomyelitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Gastroenterits	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk
Herpes zoster	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk
Lung abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0012 affected483 at risk
Pyelonephritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Gastritis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk
Small intestine obstruction	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0012 affected483 at risk
Bladder diverticulum	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Urinary retention	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected483 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected482 at risk EG0012 affected482 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected482 at risk
Circulatory collapse	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Extremity necrosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Hypertensive crisis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected482 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected482 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected482 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected482 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Blood parathyroid hormone decreased	Investigations	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected482 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected482 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0011 affected482 at risk
Angioplasty	Surgical and medical procedures	MedDRA 14.0	Systematic Assessment	EG0001 affected482 at risk EG0010 affected482 at risk
Acute vestibular syndrome	Ear and labyrinth disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected482 at risk
Chest pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0013 affected483 at risk
Schizophrenia, paranoid type	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected482 at risk EG0011 affected483 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Urinary tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00027 affected482 at risk EG00118 affected483 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00026 affected482 at risk EG00126 affected483 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00015 affected482 at risk EG00124 affected483 at risk
Hypoglycemia	Endocrine disorders	MedDRA 14.0	Systematic Assessment	EG000101 affected482 at risk EG00184 affected483 at risk

Certain Agreements

ID	Term
D003924	Diabetes Mellitus, Type 2
D002318	Cardiovascular Diseases
D003920	Diabetes Mellitus

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

ID	Title	Description
BG000	Dapagliflozin	Dapagliflozin 10 mg plus usual care
BG001	Placebo	Placebo plus usual care
BG002	Total	Total of all reporting groups