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
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 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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
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; Time to first event included in the composite endpoint of CV death or hospitalization due to heart failure.; up to 6 years
Secondary Outcome Measures
    Time to first event of renal composite endpoint: Confirmed sustained ≥40% decrease in eGFR to eGFR <60 ml/min/1.73m2 and/or ESRD and/or renal or CV death; up to 6 years; Time to All-cause mortality; 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
All
Age Range
40 Years - 130 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
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)
Midsomer Norton
Somerset
BA3 2UH
Addlestone
Surrey
KT15 2BH
Coventry
Warwickshire
CV6 4DD
GSK Investigational Site
Corsham
Wiltshire
SN13 9DL
Pfizer Investigational Site
Blackpool
Lancashire
FY4 3AD
Belfast
BT7 2EB
Pfizer Investigational Site
Canterbury
CT1 3HX
Irvine
Ayrshire
KA12 0AY
Whitstable
Kent
CT5 3SE
Belfast
BT13 3BW
Boehringer Ingelheim Investigational Site
Glasgow
G69 7AD
Aston Clinton Surgery
Aston Clinton
Buckinghamshire
HP22 5LB
Almirall Investigational Site #11
Burbage
LE10 2SE
Ecclesfield Group Practice
Sheffield
S35 9XQ
Research Site
Mortimer Reading
RG7 3SQ
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, Czechia, 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

15 Sep 2017