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

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ClinicalTrials.gov Identifier: NCT01730534
Recruitment Status : Active, not recruiting
First Posted : November 21, 2012
Last Update Posted : December 28, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Non-Insulin-Dependent High Risk for Cardiovascular Event Drug: Dapagliflozin 10 mg Drug: Placebo tablet Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 25, 2013
Estimated Primary Completion Date : July 18, 2018
Estimated Study Completion Date : July 18, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dapagliflozin
Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Drug: Dapagliflozin 10 mg
Oral dose (od)
Placebo Comparator: Placebo
Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Drug: Placebo tablet
Oral dose (od)


Outcome Measures

Primary Outcome Measures :
  1. Time to first event included in the composite endpoint of CV death, MI or ischemic stroke [ Time Frame: up to 6 years ]
    Safety and co-primary efficacy

  2. Time to first event included in the composite endpoint of CV death or hospitalization due to heart failure. [ Time Frame: up to 6 years ]
    Co-primary efficacy


Secondary Outcome Measures :
  1. Time to first event of 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 6 years ]
  2. Time to All-cause mortality [ Time Frame: up to 6 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730534


  Show 809 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
The TIMI Study Group
Hadassah Medical Organization
Investigators
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01730534     History of Changes
Other Study ID Numbers: D1693C00001
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017

Keywords provided by AstraZeneca:
Phase IIIb
T2DM
cardiovascular events

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases