Dapagliflozin Evaluation in Patients With Inadequately Co... | NCT02460978

ID	Type	Description	Link
2014-004599-49	EudraCT Number
D1695C00007	Other Identifier	AstraZeneca

Status Module

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight 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
Dapagliflozin 5 mg	Experimental	Dapagliflozin 5 mg tablet orally, once daily for 52 weeks	Drug: Dapagliflozin
Dapagliflozin 10 mg	Experimental	Dapagliflozin 10 mg tablet orally, once daily for 52 weeks	Drug: Dapagliflozin
Placebo	Placebo Comparator	Placebo tablet orally, once daily for 52 weeks	Other: Placebo for dapagliflozin

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin	Drug	Tablets	Dapagliflozin 10 mg Dapagliflozin 5 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adjusted Mean Change From Baseline in HbA1c at Week 24	To compare the change from baseline in HbA1c between dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment	Baseline and 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24	To compare the percent change from baseline in total daily insulin dose with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment	Baseline and 24 weeks

Eligibility Module

Name	Affiliation	Role
Anna Maria Langkilde, MD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Concord	California	94520	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39918875	Derived	Nardone M, Kugathasan L, Sridhar VS, Dutta P, Campbell DJT, Layton AT, Perkins BA, Barbour S, Lam TKT, Levin A, Lovblom LE, Mucsi I, Rabasa-Lhoret R, Rac VE, Senior P, Sigal RJ, Stanimirovic A, Persson F, Stougaard EB, Doria A, Cherney DZI. Modeling Cardiorenal Protection with Sodium-Glucose Cotransporter 2 Inhibition in Type 1 Diabetes: An Analysis of DEPICT-1 and DEPICT-2. Clin J Am Soc Nephrol. 2025 Apr 1;20(4):529-538. doi: 10.2215/CJN.0000000641. Epub 2025 Feb 7.
38770818

Label	URL
MB102230\_CSP	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	DAPA 5 MG + INS	Dapagliflozin 5 mg plus insulin
FG001	DAPA 10 MG + INS	Dapagliflozin 10 mg plus insulin

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
SAP	No	Yes	No	Statistical Analysis Plan	Sep 22, 2017	Aug 24, 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

Title	Measurements
	BG00042.7± 13.35 BG00142.4± 12.80 BG00243.0± 13.73 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000153 BG001149 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000210 BG001219 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 From Baseline in HbA1c at Week 24

To compare the change from baseline in HbA1c between dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment

The analysis population for this endpoint is the number of subjects in the full analysis set with non-missing baseline and at least one post-baseline value. The full analysis set consists of all randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period.

Posted

Least Squares Mean

95% Confidence Interval

HbA1c (%)

Baseline and 24 weeks

ID	Title	Description
OG000	DAPA 5 MG + INS	Dapagliflozin 5 mg plus insulin
OG001	DAPA 10 MG + INS	Dapagliflozin 10 mg plus insulin
OG002	PLA + INS	Placebo plus insulin

Units	Counts
Participants	OG000266 OG001267 OG002267

Title

Denominators

Categories

Title	Measurements
	OG000-0.34(-0.43 to -0.25) OG001-0.39(-0.48 to -0.30) OG0020.03(-0.06 to 0.12)

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 OG002	Difference vs. placebo in adjusted mean change from baseline	Mixed Models Analysis	Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, weektreatment, and weekbaseline HbA1c.	<0.0001		Mean Difference (Final Values)	-0.37	Standard Error of the Mean	0.0579	2-Sided	95	-0.49	-0.26					Superiority

Secondary

Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24

To compare the percent change from baseline in total daily insulin dose with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment

Number of subjects in full analysis set with non-missing baseline and at least one post-baseline value

Posted

Least Squares Mean

95% Confidence Interval

Percentage change

Baseline and 24 weeks

ID	Title	Description
OG000	DAPA 5 MG + INS	Dapagliflozin 5 mg plus insulin
OG001	DAPA 10 MG + INS	Dapagliflozin 10 mg plus insulin
OG002	PLA + INS	Placebo plus insulin

Units	Counts
Participants

Secondary

Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24

To compare the percentage change from baseline in body weight with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment

Number of subjects in full analysis set with non-missing baseline and at least one post-baseline value

Posted

Least Squares Mean

95% Confidence Interval

Percentage change

Baseline and 24 weeks

ID	Title	Description
OG000	DAPA 5 MG + INS	Dapagliflozin 5 mg plus insulin
OG001	DAPA 10 MG + INS	Dapagliflozin 10 mg plus insulin
OG002	PLA + INS	Placebo plus insulin

Units	Counts
Participants

Secondary

Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24

To compare the change from baseline in mean value of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment

The number of subjects in the full analysis set with non-missing baseline and at least one post-baseline value

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline and 24 weeks

ID	Title	Description
OG000	DAPA 5 MG + INS	Dapagliflozin 5 mg plus insulin
OG001	DAPA 10 MG + INS	Dapagliflozin 10 mg plus insulin
OG002	PLA + INS	Placebo plus insulin

Units	Counts
Participants

Secondary

Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24

To compare the change from baseline in mean amplitude of glucose excursions (MAGE) of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment

Number of subjects in the full analysis set with non-missing baseline and at least one post-baseline value

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline and 24 weeks

ID	Title	Description
OG000	DAPA 5 MG + INS	Dapagliflozin 5 mg plus insulin
OG001	DAPA 10 MG + INS	Dapagliflozin 10 mg plus insulin
OG002	PLA + INS	Placebo plus insulin

Units	Counts
Participants

Secondary

Change From Baseline in the Percent of 24-hour Glucose Readings Obtained From CGM That Falls Within the Target Range of > 70 mg/dL and <= 180 mg/dL (%) at Week 24

To compare the change from baseline in the percent of 24-hour glucose readings obtained from CGM that falls within the target range of >70 mg/dL and <=180 mg/dL with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment

Number of subjects in the full analysis set with non-missing baseline and at least one post-baseline value

Posted

Least Squares Mean

95% Confidence Interval

% of readings

Baseline and 24 weeks

ID	Title	Description
OG000	DAPA 5 MG + INS	Dapagliflozin 5 mg plus insulin
OG001	DAPA 10 MG + INS	Dapagliflozin 10 mg plus insulin
OG002	PLA + INS	Placebo plus insulin

Units	Counts
Participants

Secondary

Percentage of Subjects With HbA1c Reduction From Baseline to Week 24 Last Observation Carried Forward (LOCF) >= 0.5% and Without Severe Hypoglycemia Events at Week 24

To compare dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin for the proportion of subjects achieving an HbA1c reduction from baseline to Week 24 visit >=0.5% without severe hypoglycemia events

Number of subjects in the full analysis set with non-missing baseline and Week 24 (LOCF) values.

Posted

Count of Participants

Participants

Baseline and 24 weeks

ID	Title	Description
OG000	DAPA 5 MG + INS	Dapagliflozin 5 mg plus insulin
OG001	DAPA 10 MG + INS	Dapagliflozin 10 mg plus insulin
OG002	PLA + INS	Placebo plus insulin

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DAPA 5 MG + INS	Dapagliflozin 5 mg plus insulin	271	18	271	79	271
EG001	DAPA 10 MG + INS	Dapagliflozin 10 mg plus insulin	270	7	270	77	270
EG002	PLA + INS	Placebo plus insulin	272	5	272	63	272

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA version 20.0	Systematic Assessment	EG0007 events7 affected271 at risk EG0013 events3 affected270 at risk EG0020 events0 affected272 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA version 20.0	Systematic Assessment	EG0004 events3 affected271 at risk EG0010 events0 affected270 at risk EG0021 events1 affected272 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA version 20.0	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk
Ketosis	Metabolism and nutrition disorders	MedDRA version 20.0	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0010 events0 affected270 at risk EG0021 events1 affected272 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected270 at risk EG0020 events0 affected272 at risk
Coma	Nervous system disorders	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected270 at risk EG0020 events0 affected272 at risk
Diabetic hyperglycaemic coma	Nervous system disorders	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected270 at risk EG0020 events0 affected272 at risk
Seizure	Nervous system disorders	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected270 at risk EG0020 events0 affected272 at risk
Cerebral infarction	Nervous system disorders	MedDRA version 20.0	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0010 events0 affected270 at risk EG0021 events1 affected272 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA version 20.0	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk
Hypoglycaemic seizure	Nervous system disorders	MedDRA version 20.0	Systematic Assessment	EG0002 events2 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected270 at risk EG0020 events0 affected272 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected270 at risk EG0020 events0 affected272 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA version 20.0	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk
Cardiac arrest	Cardiac disorders	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected270 at risk EG0020 events0 affected272 at risk
Angina pectoris	Cardiac disorders	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0010 events0 affected270 at risk EG0021 events1 affected272 at risk
Enteritis	Gastrointestinal disorders	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected270 at risk EG0020 events0 affected272 at risk
Chest pain	General disorders	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected270 at risk EG0020 events0 affected272 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0011 events1 affected270 at risk EG0020 events0 affected272 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 20.0	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk
Cellulitis	Infections and infestations	MedDRA version 20.0	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk
Labyrinthitis	Infections and infestations	MedDRA version 20.0	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk
Pneumonia	Infections and infestations	MedDRA version 20.0	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk
Pyelonephritis	Infections and infestations	MedDRA version 20.0	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk
Sepsis	Infections and infestations	MedDRA version 20.0	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk
Urinary tract infection	Infections and infestations	MedDRA version 20.0	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA version 20.0	Systematic Assessment	EG0000 events0 affected271 at risk EG0010 events0 affected270 at risk EG0021 events1 affected272 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA version 20.0	Systematic Assessment	EG0001 events1 affected271 at risk EG0010 events0 affected270 at risk EG0020 events0 affected272 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Viral upper respiratory tract infection	Infections and infestations	MedDRA version 20.0	Systematic Assessment	EG00046 events39 affected271 at risk EG00156 events44 affected270 at risk EG00251 events42 affected272 at risk
Headache	Nervous system disorders	MedDRA version 20.0	Systematic Assessment	EG00011 events10 affected271 at risk EG00115 events15 affected270 at risk EG00211 events10 affected272 at risk
Pollakiuria	Renal and urinary disorders	MedDRA version 20.0	Systematic Assessment	EG00023 events22 affected271 at risk EG00115 events14 affected270 at risk EG0026 events6 affected272 at risk
Thirst	General disorders	MedDRA version 20.0	Systematic Assessment	EG0007 events6 affected271 at risk EG00114 events14 affected270 at risk EG0021 events1 affected272 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 20.0	Systematic Assessment	EG00021 events16 affected271 at risk EG00112 events12 affected270 at risk EG00212 events12 affected272 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	DAPA 5 MG + INS	Dapagliflozin 5 mg plus insulin
BG001	DAPA 10 MG + INS	Dapagliflozin 10 mg plus insulin
BG002	PLA + INS	Placebo plus insulin
BG003	Total	Total of all reporting groups