Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, non-insulin-dependent, high risk for cardiovascular event
Treatments dapagliflozin 10 mg, placebo tablet
Phase phase 3
Sponsor AstraZeneca
Collaborator Bristol-Myers Squibb
Start date April 2013
End date April 2019
Trial size 17276 participants
Trial identifier NCT01730534, D1693C00001

Summary

This study is being carried out to see if dapagliflozin when added to a patients current anti-diabetes therapy is effective in reducing cardiovascular events such as myocardial infarction (MI) (heart attack), ischemic stroke, and cardiovascular (CV) related death, compared with placebo (inactive study medication).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
dapagliflozin 10 mg
Oral dose (od)
(Placebo Comparator)
Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
placebo tablet
Oral dose (od)

Primary Outcomes

Measure
Time to first event included in the composite endpoint of CV death, MI or ischemic stroke
time frame: up to 6 years

Secondary Outcomes

Measure
Time to first event of Hospitalization for Congestive Heart Failure
time frame: up to 6 years
Time to first event included in the composite endpoint of CV death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization
time frame: up to 6 years
Time to All-cause mortality
time frame: up to 6 years
Body weight change from baseline
time frame: up to 6 years

Eligibility Criteria

Male or female participants from 40 years up to 130 years old.

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

Additional Information

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
Principal investigator Itamar Raz, MD
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.