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

NCT01730534 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17190

Last updated 2019-12-26

Study results available
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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.

Conditions

  • Diabetes Mellitus, Non-Insulin-Dependent
  • High Risk for Cardiovascular Event

Interventions

DRUG

Dapagliflozin 10 mg

Oral dose (od)

DRUG

Placebo tablet

Oral dose (od)

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • The TIMI Study Group

    collaborator OTHER

  • Hadassah Medical Organization

    collaborator OTHER

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Anna Maria Langkilde, MD · AstraZeneca Sweden

  • Marc S Sabatine, MD, MPH · TIMI Study Group, Boston, MA, USA

  • Itamar Raz, MD · Hadassah Medical Organization

  • Stephen D Wiviott, MD · TIMI Study Group, MA, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-25
Primary Completion
2018-09-11
Completion
2018-09-11

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Philippines
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01730534 on ClinicalTrials.gov