Multicenter trial to evaluate the effect of dapagliflozin on the Incidence of cardiovascular events - DECLARE-TIMI58
Study identifier:D1693C00001
ClinicalTrials.gov identifier:NCT01730534
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Diabetes Mellitus, Non-Insulin-Dependent
Phase
Phase 3
Healthy volunteers
No
Study drug
Dapagliflozin 10 mg, Placebo tablet
Sex
All
Actual Enrollment
17190
Study type
Interventional
Age
40 Years - 130 Years
Date
Study Start Date: 25 Apr 2013
Primary Completion Date: 11 Sept 2018
Study Completion Date: 11 Sept 2018
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2019 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol-Myers Squibb, The TIMI Study Group, Hadassah Medical Organization
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dapagliflozin Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors | Drug: Dapagliflozin 10 mg Oral dose (od) |
| Placebo Comparator: Placebo Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors | Drug: Placebo tablet Oral dose (od) |
Contacts
Investigators
Principal Investigator
Anna Maria Langkilde
AstraZeneca Sweden
