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
Overview
- Phase
- Phase 3
- Intervention
- Dapagliflozin 10 mg
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Sponsor
- AstraZeneca
- Enrollment
- 17190
- Locations
- 1
- Primary Endpoint
- Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
- Status
- Completed
- Last Updated
- 6 years ago
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.
Investigators
Eligibility 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
Arms & Interventions
Dapagliflozin
Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Intervention: Dapagliflozin 10 mg
Placebo
Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Intervention: Placebo tablet
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)