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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01730534 |
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Date of registration:
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15/11/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events
DECLARE-TIMI58 |
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Scientific title:
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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 |
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Date of first enrolment:
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April 25, 2013 |
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Target sample size:
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17190 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01730534 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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Bulgaria
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Canada
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China
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Czech Republic
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Czechia
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France
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Germany
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Hong Kong
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Hungary
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India
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Israel
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Italy
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Japan
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Korea, Republic of
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Mexico
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Netherlands
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Philippines
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Poland
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Romania
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Russian Federation
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Slovakia
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South Africa
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Spain
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Sweden
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Taiwan
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Thailand
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Turkey
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Ukraine
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United Kingdom
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United States
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Vietnam
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Contacts
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Name:
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Marc S Sabatine, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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TIMI Study Group, Boston, MA, USA |
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Name:
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Anna Maria Langkilde, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca Sweden |
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Name:
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Stephen D Wiviott, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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TIMI Study Group, MA, USA |
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Name:
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Itamar Raz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hadassah Medical Organization |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
130 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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High Risk for Cardiovascular Event
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Diabetes Mellitus, Non-Insulin-Dependent
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Intervention(s)
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Drug: Dapagliflozin 10 mg
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Drug: Placebo tablet
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Primary Outcome(s)
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Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
[Time Frame: up to 5.2 years]
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Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke
[Time Frame: up to 5.2 years]
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Secondary Outcome(s)
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Subjects Included in the Endpoint of All-cause Mortality.
[Time Frame: up to 5.2 years]
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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.
[Time Frame: up to 5.2 years]
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Secondary ID(s)
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D1693C00001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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