A Study to Evaluate the Effect of Dapagliflozin on Blood... | NCT02413398

Status Module

Label	Type	Description	Intervention Names
Dapagliflozin	Experimental	10 mg Tablets, Oral, Once daily, 24 weeks	Drug: Dapagliflozin 10 mg
Placebo	Placebo Comparator	Matching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks	Drug: Matching Placebo for Dapagliflozin

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin 10 mg	Drug	Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy	Dapagliflozin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24	To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24.	Baseline, Week 24

Secondary Outcomes

Measure	Description	Time Frame
Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.	To compare the mean percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" represents the number with change from baseline available at Week 24.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Huntsville	Alabama	35801	United States
Research Site

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.
29888547

Label	URL
Redacted Study Protocol	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Dapagliflozin 10mg QD	10 mg Tablets, Oral, Once daily, 24 weeks
FG001	Placebo QD	Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 17, 2017	Jun 22, 2018

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

- ParticipantsBG000160
- ParticipantsBG001161
- ParticipantsBG002321

Title	Measurements

Age, Customized

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000160 ParticipantsBG001161 ParticipantsBG002

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000160 ParticipantsBG001161 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000160 ParticipantsBG001161 ParticipantsBG002

Body Mass Index

Mean

Standard Deviation

kg/m^2

Title	Denominators	Categories
	ParticipantsBG000160 ParticipantsBG001161 ParticipantsBG002

Estimated Glomular Filtration Rate (eGFR)

Mean

Standard Deviation

mL/min/1.73 m^2

Title	Denominators	Categories
	ParticipantsBG000160 ParticipantsBG001161 ParticipantsBG002

Urine Albumin-to-Creatinine Ratio (UACR)

159/160 subjects in the Dapaglifozin group had an enrolment UACR value.

Mean

Standard Deviation

mg/g

Title	Denominators	Categories
	ParticipantsBG000159 ParticipantsBG001161 ParticipantsBG002

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 From Baseline in Hemoglobin A1c (HbA1c) at Week 24

To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24.

For glycaemic measurements (HbA1c and FPG), all measurements after the first dose of rescue medication were excluded. For other non-glycaemic measurements (body weight and SBP), all measurements after the first dose of rescue medication were included.

Posted

Mean

Standard Error

percent

Baseline, Week 24

ID	Title	Description
OG000	Dapagliflozin	10 mg Tablets, Oral, Once daily, 24 weeks
OG001	Placebo	Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks

Units	Counts
Participants	OG000142 OG001134

Title

Denominators

Categories

Title	Measurements
	OG000-0.37± 0.10 OG001-0.03± 0.10

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	Difference in adjusted mean change from baseline (MMRM model)	Mixed Models Analysis		<0.001		Mean Difference (Final Values)	-0.34	Standard Error of the Mean	0.10	2-Sided	95	-0.53	-0.15					Superiority

Secondary

Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.

To compare the mean percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" represents the number with change from baseline available at Week 24.

Posted

Mean

Standard Error

percent change

Baseline, Week 24

ID	Title	Description
OG000	Dapagliflozin	10 mg Tablets, Oral, Once daily, 24 weeks
OG001	Placebo	Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks

Units	Counts
Participants	OG000

Secondary

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

To compare the mean change from baseline in FPG between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" represents the number with change from baseline available at Week 24.

Posted

Mean

Standard Error

mg/dL

Baseline, Week 24

ID	Title	Description
OG000	Dapagliflozin	10 mg Tablets, Oral, Once daily, 24 weeks
OG001	Placebo	Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks

Units	Counts
Participants	OG000

Secondary

Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.

To compare the mean change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" represents the number with change from baseline available at Week 24.

Posted

Mean

Standard Error

mmHg

Baseline, Week 24

ID	Title	Description
OG000	Dapagliflozin	10 mg Tablets, Oral, Once daily, 24 weeks
OG001	Placebo	Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected161 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected161 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected161 at risk
Angina unstable	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0012 events1 affected161 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected161 at risk
Atrioventricular block	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected161 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected161 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected161 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected161 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected160 at risk EG0010 events0 affected161 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected161 at risk
Diabetic gangrene	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected161 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected161 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected161 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected161 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected161 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected161 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected161 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected161 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0011 events1 affected161 at risk
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected161 at risk
Acquired hydrocele	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected161 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0011 events1 affected161 at risk

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

ID	Title	Description
BG000	Dapagliflozin 10mg QD	10 mg Tablets, Oral, Once daily, 24 weeks
BG001	Placebo	Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks
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 10mg QD	10 mg Tablets, Oral, Once daily, 24 weeks	0	160	9	160	0	160
EG001	Placebo	Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks	0	161	14	161	0	161