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OpenTrials
Completed

NCT Number: NCT01730534

Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events

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.

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Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders High Risk for Cardiovascular Event Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin 10 mg

Drug

Oral dose (od)

Placebo Tablet

Drug

Oral dose (od)

Primary outcomes

  1. Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke

    Time frame: up to 5.2 years

    Safety and co-primary efficacy

  2. Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.

    Time frame: up to 5.2 years

    Co-primary efficacy

Secondary outcomes

  1. 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

    Secondary

  2. Subjects Included in the Endpoint of All-cause Mortality.

    Time frame: up to 5.2 years

    Secondary

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb
  • Hadassah Medical Organization
  • The TIMI Study Group

Registry information

Official study 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

Acronym: DECLARE-TIMI58

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2012
Registry last updated
Dec 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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