Dapagliflozin Effect on Cardiovascular Events
Research type
Research Study
Full title
A Multicentre, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes.
IRAS ID
130019
Contact name
Kausik Ray
Contact email
Sponsor organisation
Astrazeneca
Eudract number
2013-000239-28
Clinicaltrials.gov Identifier
Research summary
The aim of this study is to see whether treatment with dapagliflozin compared
with placebo when added to current background therapy will result in a reduction in the incidence of the composite endpoint of cardiovascular death, myocardial infarction (MI), or ischaemic stroke in patients with type 2 diabetes mellitus (T2DM) with either established cardiovascular disease or at least two cardiovascular risk factors in addition to T2DM.The study aims to randomise approximate 17150 patients with at least 250 from the UK. T2DM patients with the relevant eligibility criteria will receive either dapagliflozin or placebo added onto their background antidiabetic medication. Once randomised they will be seen for a study visit every 6 months to record any adverse and CV events, undergo blood and urine sampling, record changes to other medications, check compliance to the study medication, receive more study drug supply and receive dietary and lifestyle advise that could help their diabetes control. In addition, between visits, the site will contact the patient by telephone.
As the study is an Endpoint study, it will finish when the required number of CV Endpoints have been recorded. The anticipated duration of the study is approximately 6 years, with a recruitment period of approximately 3 years.
The study is sponsored by AstraZeneca in collaboration with Bristol-Myers Squibb and is being conducted in partnership with the TIMI group (Thrombolysis in Myocardial Infarction) and Hadassah Medical Centre
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
13/LO/0801
Date of REC Opinion
15 Jul 2013
REC opinion
Further Information Favourable Opinion