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

Active, not recruiting

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Placebo tablet Drug
    Intervention Desc: Oral dose (od)
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
  • Dapagliflozin 10 mg Drug
    Intervention Desc: Oral dose (od)
    ARM 1: Kind: Experimental
    Label: Dapagliflozin
    Description: Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Time to first event included in the composite endpoint of CV death, MI or ischemic stroke up to 6 years No
Secondary Time to first event of Hospitalization for Congestive Heart Failure up to 6 years No
Secondary 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 up to 6 years No
Secondary Time to All-cause mortality up to 6 years No
Secondary Body weight change from baseline up to 6 years No
Primary Time to first event included in the composite endpoint of CV death or hospitalization due to heart failure. up to 6 years
Secondary 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 up to 6 years

Sponsors