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

AstraZeneca

Status and phase: Completed; Phase 3

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

Treatments: Drug: Dapagliflozin 10 mg; Drug: Placebo tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01730534

D1693C00001

Details and patient eligibility

About

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.

Enrollment: 17,190 patients

Sex: All

Ages: 40 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

17,190 participants in 2 patient groups, including a placebo group

Dapagliflozin

Experimental group

Description:

Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors

Treatment:

Drug: Dapagliflozin 10 mg

Placebo

Placebo Comparator group

Description:

Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors

Treatment:

Drug: Placebo tablet