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

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Medical Conditions
  • Diabetes Mellitus, Non-Insulin-Dependent
  • High Risk for Cardiovascular Event
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT01730534

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
40 Years - 130 Years
Who Can Participate
Patients
Number of Participants
17276
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Glasgow
Central
Belfast
Sheffield
Oldfield Surgery
Bath
Townhead Research
Irvine
Blackpool
Lancashire
Uni Hospital Leicester
Leicester
University Hospital
Coventry
205.389.3627 Boehringer Ingelheim Investigational Site
Corsham
Stoke Mandeville Hospital and Wycombe Hospital
Aylesbury
Addlestone
Research Site
Mortimer
Kent and Canterbury Hospital
Canterbury
Kent
Research Site
Whitstable
Kent
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
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, United States, Vietnam
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 added to source

15 Nov 2012

Date updated in source

22 Sep 2016