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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Bristol-Myers Squibb
The TIMI Study Group
Hadassah Medical Organization
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01730534
First received: November 15, 2012
Last updated: June 19, 2017
Last verified: June 2017
November 15, 2012
June 19, 2017
April 25, 2013
April 29, 2019   (Final data collection date for primary outcome measure)
  • 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
  • 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
Time to first event included in the composite endpoint of CV death, MI or ischemic stroke [ Time Frame: up to 6 years ]
Complete list of historical versions of study NCT01730534 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time to All-cause mortality [ Time Frame: up to 6 years ]
  • 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 ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
  • Diabetes Mellitus, Non-Insulin-Dependent
  • High Risk for Cardiovascular Event
  • Drug: Dapagliflozin 10 mg
    Oral dose (od)
  • Drug: Placebo tablet
    Oral dose (od)
  • 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
Bloch MJ. Blood pressure effects of SGLT2 inhibitors make them an attractive option in diabetic patients with hypertension. J Am Soc Hypertens. 2016 Mar;10(3):186-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
17276
April 29, 2019
April 29, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 130 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Czech Republic
 
NCT01730534
D1693C00001
Yes
Not Provided
Not Provided
AstraZeneca
AstraZeneca
  • Bristol-Myers Squibb
  • The TIMI Study Group
  • Hadassah Medical Organization
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
AstraZeneca
June 2017

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