Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Non-Insulin-Dependent, High Risk for Cardiovascular Event

Intervention / Treatment
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* Drug: Dapagliflozin 10 mg
* Drug: Placebo tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapagliflozin<br>Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors | Drug: Dapagliflozin 10 mg<br>* Oral dose (od)<br>|
| Placebo Comparator: Placebo<br>Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors | Drug: Placebo tablet<br>* Oral dose (od)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke | Safety and co-primary efficacy | up to 5.2 years | 
| Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. | Co-primary efficacy | up to 5.2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Secondary | up to 5.2 years | 
| Subjects Included in the Endpoint of All-cause Mortality. | Secondary | up to 5.2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase IIIb, T2DM, cardiovascular events