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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 17,190
- Locations
- 1
- Primary Endpoint
- Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 130 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Dapagliflozin
Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Intervention: Dapagliflozin 10 mg (Drug)
Placebo
Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Intervention: Placebo tablet (Drug)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- 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 years)
- Subjects Included in the Endpoint of All-cause Mortality.(up to 5.2 years)