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Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events (DECLARE-TIMI58)

This study is ongoing, but not recruiting participants.
Bristol-Myers Squibb
The TIMI Study Group
Hadassah Medical Organization
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: November 15, 2012
Last updated: December 21, 2016
Last verified: December 2016
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.

Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
High Risk for Cardiovascular Event
Drug: Dapagliflozin 10 mg
Drug: Placebo tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to first event included in the composite endpoint of CV death, MI or ischemic stroke [ Time Frame: up to 6 years ]
    Safety and co-primary efficacy

  • Time to first event included in the composite endpoint of CV death or hospitalization due to heart failure. [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
    Co-primary efficacy

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 [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  • Time to All-cause mortality [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 17150
Study Start Date: April 2013
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapagliflozin
Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Drug: Dapagliflozin 10 mg
Oral dose (od)
Placebo Comparator: Placebo
Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Drug: Placebo tablet
Oral dose (od)


Ages Eligible for Study:   40 Years to 130 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01730534

  Show 660 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
The TIMI Study Group
Hadassah Medical Organization
Study Director: Anna Maria Langkilde, MD AstraZeneca Sweden
Study Chair: Marc S Sabatine, MD, MPH TIMI Study Group, Boston, MA, USA
Principal Investigator: Itamar Raz, MD Hadassah Medical Organization
Principal Investigator: Stephen D Wiviott, MD TIMI Study Group, MA, USA
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT01730534     History of Changes
Other Study ID Numbers: D1693C00001 
Study First Received: November 15, 2012
Last Updated: December 21, 2016
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Ministry of Health
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong:State Food and Drug Administration
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Israel: only local ERB for each site
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Philippines : Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
Thailand: only local ERB for each site
Turkey: Turkish MoH Pharmacy Directora
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ukraine: State Pharmacological Center - Ministry of Health
Vietnam: Ministry of Health

Keywords provided by AstraZeneca:
Phase IIIb
cardiovascular events

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on January 18, 2017