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Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events (DECLARE-TIMI58)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01730534
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : December 26, 2019
Last Update Posted : December 26, 2019
Sponsor:
Collaborators:
Bristol-Myers Squibb
The TIMI Study Group
Hadassah Medical Organization
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 15, 2012
First Posted Date  ICMJE November 21, 2012
Results First Submitted Date  ICMJE September 6, 2019
Results First Posted Date  ICMJE December 26, 2019
Last Update Posted Date December 26, 2019
Actual Study Start Date  ICMJE April 25, 2013
Actual Primary Completion Date September 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
  • Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke [ Time Frame: up to 5.2 years ]
    Safety and co-primary efficacy
  • Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. [ Time Frame: up to 5.2 years ]
    Co-primary efficacy
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2012)		 Time to first event included in the composite endpoint of CV death, MI or ischemic stroke [ Time Frame: up to 6 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
  • 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. [ Time Frame: up to 5.2 years ]
    Secondary
  • Subjects Included in the Endpoint of All-cause Mortality. [ Time Frame: up to 5.2 years ]
    Secondary
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2012)
  • Time to first event of Hospitalization for Congestive Heart Failure [ Time Frame: up to 6 years ]
  • Time to first event included in the composite endpoint of CV death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization [ Time Frame: up to 6 years ]
  • Time to All-cause mortality [ Time Frame: up to 6 years ]
  • Body weight change from baseline [ Time Frame: up to 6 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Non-Insulin-Dependent
  • High Risk for Cardiovascular Event
Intervention  ICMJE
  • Drug: Dapagliflozin 10 mg
    Oral dose (od)
  • Drug: Placebo tablet
    Oral dose (od)
Study Arms  ICMJE
  • Experimental: Dapagliflozin
    Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
    Intervention: Drug: Dapagliflozin 10 mg
  • Placebo Comparator: Placebo
    Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
    Intervention: Drug: Placebo tablet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2018)		 17190
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2012)		 17150
Actual Study Completion Date  ICMJE September 11, 2018
Actual Primary Completion Date September 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Czechia,   France,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Philippines,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States,   Vietnam
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01730534
Other Study ID Numbers  ICMJE D1693C00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Bristol-Myers Squibb
  • The TIMI Study Group
  • Hadassah Medical Organization
Investigators  ICMJE
Study Director: Anna Maria Langkilde, MD AstraZeneca Sweden
Study Chair: Marc S Sabatine, MD, MPH TIMI Study Group, Boston, MA, USA
Principal Investigator: Itamar Raz, MD Hadassah Medical Organization
Principal Investigator: Stephen D Wiviott, MD TIMI Study Group, MA, USA
PRS Account AstraZeneca
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP