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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01730534




Registration number
NCT01730534
Ethics application status
Date submitted
15/11/2012
Date registered
21/11/2012
Date last updated
26/12/2019

Titles & IDs
Public title
Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events
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
Secondary ID [1] 0 0
D1693C00001
Universal Trial Number (UTN)
Trial acronym
DECLARE-TIMI58
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Non-Insulin-Dependent 0 0
High Risk for Cardiovascular Event 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dapagliflozin 10 mg
Treatment: Drugs - Placebo tablet

Experimental: Dapagliflozin - Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors

Placebo Comparator: Placebo - Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors


Treatment: Drugs: Dapagliflozin 10 mg
Oral dose (od)

Treatment: Drugs: Placebo tablet
Oral dose (od)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke
Timepoint [1] 0 0
up to 5.2 years
Primary outcome [2] 0 0
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
Timepoint [2] 0 0
up to 5.2 years
Secondary outcome [1] 0 0
Subjects Included in the 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.
Timepoint [1] 0 0
up to 5.2 years
Secondary outcome [2] 0 0
Subjects Included in the Endpoint of All-cause Mortality.
Timepoint [2] 0 0
up to 5.2 years

Eligibility
Key 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
Minimum age
40 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/09/2018
Sample size
Target
Accrual to date
Final
17190
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide - Oaklands Park
Recruitment hospital [2] 0 0
Research Site - Ashford
Recruitment hospital [3] 0 0
Research Site - Box Hill
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Research Site - Camperdown
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Research Site - Darlinghurst
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Research Site - Fullarton
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Research Site - Geelong
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Research Site - Heidelberg West
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Research Site - Melbourne
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Research Site - Milton
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Research Site - Murdoch
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Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
5046 - Adelaide - Oaklands Park
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5035 - Ashford
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3128 - Box Hill
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2050 - Camperdown
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2010 - Darlinghurst
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5063 - Fullarton
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2605 - Garran
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3220 - Geelong
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3081 - Heidelberg West
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4029 - Herston
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6027 - Joondalup
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2035 - Maroubra
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3004 - Melbourne
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4064 - Milton
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6150 - Murdoch
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2500 - Wollongong
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Ho Chi Minh City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The TIMI Study Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Hadassah Medical Organization
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01730534
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anna Maria Langkilde, MD
Address 0 0
AstraZeneca Sweden
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01730534