FindTrial
Sign In

Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events

Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01730534
Acronym
DECLARE-TIMI58
Enrollment
17190
Registered
2012-11-21
Start date
2013-04-25
Completion date
2018-09-11
Last updated
2019-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Non-Insulin-Dependent, High Risk for Cardiovascular Event

Keywords

Phase IIIb, T2DM, cardiovascular events

Brief summary

This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.

Interventions

DRUGDapagliflozin 10 mg

Oral dose (od)

DRUGPlacebo tablet

Oral dose (od)

Sponsors

Bristol-Myers Squibb
CollaboratorINDUSTRY
The TIMI Study Group
CollaboratorOTHER
Hadassah Medical Organization
CollaboratorOTHER
AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 130 Years
Healthy volunteers
No

Inclusion criteria

* Provision of informed consent prior to any study specific procedures * Female or male aged ≥40 years * Diagnosed with Type 2 Diabetes * High Risk for Cardiovascular events

Exclusion criteria

* Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time * Chronic cystitis and/or recurrent urinary tract infections * Pregnant or breast-feeding patients

Design outcomes

Primary

MeasureTime frameDescription
Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Strokeup to 5.2 yearsSafety and co-primary efficacy
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.up to 5.2 yearsCo-primary efficacy

Secondary

MeasureTime frameDescription
Subjects Included in the Renal Composite Endpoint: Confirmed Sustained ≥40% Decrease in eGFR to eGFR <60 ml/Min/1.73m2 and/or ESRD and/or Renal or CV Death.up to 5.2 yearsSecondary
Subjects Included in the Endpoint of All-cause Mortality.up to 5.2 yearsSecondary

Countries

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Philippines, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States, Vietnam

Participant flow

Participants by arm

ArmCount
Dapa 10 mg
Dapagliflozin 10 mg tablets administered orally once daily
8,582
Placebo
Matching placebo for dapagliflozin 10 mg administered orally once daily
8,578
Total17,160

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up1218
Overall StudyWithdrawal by Subject97127

Baseline characteristics

CharacteristicPlaceboDapa 10 mgTotal
Age, Continuous64.0 years
STANDARD_DEVIATION 6.8
63.9 years
STANDARD_DEVIATION 6.8
63.9 years
STANDARD_DEVIATION 6.8
Age, Customized
<65 years
4622 Participants4631 Participants9253 Participants
Age, Customized
>=65 years
3956 Participants3951 Participants7907 Participants
Age, Customized
<75 years
8020 Participants8044 Participants16064 Participants
Age, Customized
>=75 years
558 Participants538 Participants1096 Participants
Baseline CV risk category
Established CV disease
3500 Participants3474 Participants6974 Participants
Baseline CV risk category
Multiple risk factors for CV events
5078 Participants5108 Participants10186 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1270 Participants1298 Participants2568 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7308 Participants7284 Participants14592 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
52 Participants52 Participants104 Participants
Race/Ethnicity, Customized
Asian
1155 Participants1148 Participants2303 Participants
Race/Ethnicity, Customized
Black or African American
308 Participants295 Participants603 Participants
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
13 Participants9 Participants22 Participants
Race/Ethnicity, Customized
Other
240 Participants235 Participants475 Participants
Race/Ethnicity, Customized
White
6810 Participants6843 Participants13653 Participants
Sex: Female, Male
Female
3251 Participants3171 Participants6422 Participants
Sex: Female, Male
Male
5327 Participants5411 Participants10738 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
529 / 8,582570 / 8,578
other
Total, other adverse events
268 / 8,574342 / 8,569
serious
Total, serious adverse events
3,205 / 8,5743,418 / 8,569

Outcome results

Primary

Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke

Safety and co-primary efficacy

Time frame: up to 5.2 years

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Dapa 10 mgSubjects Included in the Composite Endpoint of CV Death, MI or Ischemic StrokeNumber of patients with an event756 Participants
PlaceboSubjects Included in the Composite Endpoint of CV Death, MI or Ischemic StrokeNumber of patients with an event803 Participants
p-value: 0.17295% CI: [0.84, 1.03]Regression, Cox
Primary

Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.

Co-primary efficacy

Time frame: up to 5.2 years

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Dapa 10 mgSubjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.Number of patients with an event417 Participants
PlaceboSubjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.Number of patients with an event496 Participants
p-value: 0.00595% CI: [0.73, 0.95]Regression, Cox
Secondary

Subjects Included in the Endpoint of All-cause Mortality.

Secondary

Time frame: up to 5.2 years

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Dapa 10 mgSubjects Included in the Endpoint of All-cause Mortality.Number of patients with an event529 Participants
PlaceboSubjects Included in the Endpoint of All-cause Mortality.Number of patients with an event570 Participants
p-value: 0.19895% CI: [0.82, 1.04]Regression, Cox
Secondary

Subjects Included in the Renal Composite Endpoint: Confirmed Sustained ≥40% Decrease in eGFR to eGFR <60 ml/Min/1.73m2 and/or ESRD and/or Renal or CV Death.

Secondary

Time frame: up to 5.2 years

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Dapa 10 mgSubjects Included in the Renal Composite Endpoint: Confirmed Sustained ≥40% Decrease in eGFR to eGFR <60 ml/Min/1.73m2 and/or ESRD and/or Renal or CV Death.Number of patients with an event370 Participants
PlaceboSubjects Included in the Renal Composite Endpoint: Confirmed Sustained ≥40% Decrease in eGFR to eGFR <60 ml/Min/1.73m2 and/or ESRD and/or Renal or CV Death.Number of patients with an event480 Participants
p-value: <0.00195% CI: [0.67, 0.87]Regression, Cox

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026