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

• Status: Completed
• Trial end date: 2018-09-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborators: Bristol-Myers Squibb; Hadassah Medical Organization; The TIMI Study Group
• Treatments: Dapagliflozin

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