Dapagliflozin DPPIV Inhibitor add-on Study | NCT00984867

NCT00984867

Status Module

Sponsor/Collaborators Module

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions 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	Active Comparator	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, 48 weeks	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adjusted Mean Change in HbA1c Levels	To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.	Baseline to Week 24

Secondary Outcomes

Measure	Description	Time Frame
Adjusted Mean Change in Body Weight	To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.	Baseline to Week 24
Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Serge Jabbour, MD	Thomas Jefferson University, Philadelphia	Principal Investigator

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24144654	Result	Jabbour SA, Hardy E, Sugg J, Parikh S; Study 10 Group. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care. 2014;37(3):740-50. doi: 10.2337/dc13-0467. Epub 2013 Oct 21.
38770818	Derived

Label	URL
D1690C00010\_Clinical\_Study\_Report\_Synopsis	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Placebo plus sitagliptin alone or in combination with metformin
FG001	Dapagliflozin	Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.

FG000226 subjectsOf the 226 randomized and treated participants only 224 were included in the full analysis set.

FG001225 subjectsOf the 225 randomized and treated participants only 223 were included in the full analysis set.

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.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo plus sitagliptin alone or in combination with metformin
BG001	Dapagliflozin	Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
BG002	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

Title	Measurements
	BG00055.0± 10.20 BG00154.8± 10.42 BG00254.9± 10.30

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000106 BG00196 BG002

HbA1c

Mean

Standard Deviation

HbA1c [%]

Title

Denominators

Categories

Title	Measurements
	BG0007.97± 0.778 BG0017.90± 0.806 BG002

Body weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00089.23± 20.887 BG00191.02± 21.637 BG002

FPG

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000162.97± 34.452 BG001162.19± 36.825 BG002

Seated SBP in subjects with baseline seated SBP ≥130 mmHg

Mean

Standard Deviation

mmHg

Title

Denominators

Categories

Title	Measurements
	BG000139.30± 8.507 BG001140.46± 8.018 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 change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.

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	Placebo	Placebo plus sitagliptin alone or in combination with metformin
OG001	Dapagliflozin	Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin

Units	Counts
Participants	OG000223 OG001223

Title

Denominators

Categories

Title	Measurements
	OG0000.04± 0.0509(-0.06 to 0.14) OG001-0.45± 0.0509(-0.55 to -0.35)

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. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group	ANCOVA	with treatment group and stratum as effects and baseline value as covariate	<0.0001	Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives, based on data from both strata combined	Mean Difference (Final Values)	-0.48	Standard Error of the Mean	0.0720	2-Sided	95	-0.62	-0.34				No

Secondary

Adjusted Mean Change in Body Weight

To compare the change in total body weight achieved with dapagliflozin versus placebo 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

Baseline to Week 24

ID	Title	Description
OG000	Placebo	Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
OG001	Dapagliflozin	Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.

Units	Counts
Participants	OG000

Secondary

Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%

To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.

Full analysis set, participants with baseline HbA1c >=8% and Week 24 (LOCF) value

Posted

Least Squares Mean

95% Confidence Interval

Percent

Baseline to Week 24

ID	Title	Description
OG000	Placebo	Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
OG001	Dapagliflozin	Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.

Units	Counts
Participants	OG000

Secondary

Adjusted Mean Change in Fasting Plasma Glucose (FPG)

To compare the change in FPG achieved with dapagliflozin versus placebo 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

mg/dL

Baseline to Week 24

ID	Title	Description
OG000	Placebo	Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
OG001	Dapagliflozin	Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.

Units	Counts
Participants	OG000

Secondary

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

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

Full analysis set, participants with baseline SBP>=130mmHg and Week 8 (LOCF) value

Posted

Least Squares Mean

95% Confidence Interval

mmHg

Baseline to Week 8

ID	Title	Description
OG000	Placebo	Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
OG001	Dapagliflozin	Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.

Units	Counts
Participants	OG000

Secondary

Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise

To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo 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

mg/dL

Baseline to Week 24

ID	Title	Description
OG000	Placebo	Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
OG001	Dapagliflozin	Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.

Units	Counts
Participants	OG000

Secondary

Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline

To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.

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

Posted

Least Squares Mean

95% Confidence Interval

Percentage of participants

Baseline to Week 24

ID	Title	Description
OG000	Placebo	Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
OG001	Dapagliflozin	Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.

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	Placebo	Placebo plus sitagliptin alone or in combination with metformin. Safety analysis set.			9	226	14	226
EG001	Dapagliflozin	Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Safety analysis set.			10	225	9	225

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected226 at risk EG0011 affected225 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected226 at risk EG0011 affected225 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected226 at risk EG0011 affected225 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected226 at risk EG0010 affected225 at risk
Device dislocation	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected226 at risk EG0011 affected225 at risk
Medical device pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected226 at risk EG0011 affected225 at risk
Non-cardiac chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected226 at risk EG0011 affected225 at risk
Angina pectoris	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected226 at risk EG0011 affected225 at risk
Angina unstable	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected226 at risk EG0011 affected225 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected226 at risk EG0011 affected225 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected226 at risk EG0011 affected225 at risk
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected226 at risk EG0011 affected225 at risk
Viral infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected226 at risk EG0010 affected225 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected226 at risk EG0011 affected225 at risk
Arteriosclerosis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected226 at risk EG0011 affected225 at risk
Ischaemia	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected226 at risk EG0010 affected225 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected226 at risk EG0010 affected225 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0002 affected226 at risk EG0010 affected225 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected226 at risk EG0010 affected225 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected226 at risk EG0010 affected225 at risk
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected226 at risk EG0010 affected225 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment		EG00014 affected226 at risk EG0019 affected225 at risk

For participants who did not complete 8 and/or 24 weeks, respectively, LOCF was used. All endpoints were evaluated by excluding data after rescue with the exception of systolic blood pressure which was evaluated regardless of rescue medication.

Certain Agreements

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
C529054	dapagliflozin

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