Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events | Not Recruiting
Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events
DECLARE-TIMI58
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Diabetes Mellitus, Non-Insulin-Dependent
  • High Risk for Cardiovascular Event
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
NCT01730534
Primary Trial ID Number
Summary
This study is being carried out to see if dapagliflozin when added to a patients current anti-diabetes therapy is effective in reducing cardiovascular events such as myocardial infarction (MI) (heart attack), ischemic stroke, and cardiovascular (CV) related death, compared with placebo (inactive study medication).
Research Details
  • 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
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Dapagliflozin 10 mg, Drug : Placebo tablet

Study Arm Groups : Dapagliflozin, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
  • Time to first event included in the composite endpoint of CV death, MI or ischemic stroke; up to 6 years
Secondary Outcome Measures
  • Time to first event of Hospitalization for Congestive Heart Failure; up to 6 years; Time to first event included in the composite endpoint of CV death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization; up to 6 years; Time to All-cause mortality; up to 6 years; Body weight change from baseline; up to 6 years
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
40 Years - N/A
Who Can Participate
Patients
Number of Participants
17150
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Leicester
Ulster Hospital
Belfast
Glasgow
Scotland
Research Site
Blackpool
Sheffield
Research Site
Bath
Research Site
Coventry
Pfizer Investigational Site
Addlestone
Surrey
205.389.3632 Boehringer Ingelheim Investigational Site
Irvine
Stoke Mandeville Hospital
Aylesbury
Research Site
Canterbury
205.389.3627 Boehringer Ingelheim Investigational Site
Corsham
Research Site
Whitstable
Kent
Research Site
Mortimer Reading
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Vietnam
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
  • Bristol-Myers Squibb
  • The TIMI Study Group
  • Hadassah Medical Organization
Other Study ID Numbers
D1693C00001
Sponsor(s)
AstraZeneca
Key Dates

Recruitment Start Date

Apr 2013

Recruitment End Date

Apr 2019

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

15 Nov 2012

Last Updated

11 Jun 2015