Cardiovascular Effects of Empagliflozin in Diabetes Mellitus
Research type
Research Study
Full title
Cardiovascular Effects of Empagliflozin in Diabetes Mellitus
IRAS ID
241152
Contact name
Sven Plein
Contact email
Sponsor organisation
University of Leeds
ISRCTN Number
ISRCTN82391603.
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The prevalence of type 2 diabetes in the UK has more than doubled in the past 20 years and is expected to continue to rise. Despite improvements in diagnosis and therapy, the life expectancy of patients with type 2 diabetes remains significantly lower than that of the general population. Type 2 diabetes is associated with an increased cardiovascular risk compared to the general population, even after adjustment for other risk factors, and this risk has proved difficult to modify. Older medications aimed at improving blood sugar control, including sitagliptin, have shown no significant improvement in cardiovascular outcomes. Recently, the a new medication (sodium-glucose co-transporter 2 inhibitor), empagliflozin, has been shown to decrease both cardiovascular and all-cause mortality and a decrease in heart failure admissions in patients with type 2 diabetes and known cardiovascular disease. The mechanisms by which empagliflozin causes this reduction in heart failure and cardiovascular mortality are as yet unknown.
The aim of this study is to determine the effects of empagliflozin on the heart in a population of patients with similar characteristics as studied in recent clinical trials.
We will invite patients with known cardiovascular disease and recent heart attack (myocardial infarction), and with known type 2 diabetes, to take part in this study. In a cross-over study patients will receive both sitagliptin and empagliflozin and undergo serial assessment, including cardiac magnetic resonance (MRI) imaging of scar (extracellular fibrosis) and blood flow to heart muscle (quantitative adenosine stress perfusion) imaging as well as assessment of diabetes status including using blood tests for HbA1c and fasting glucose/insulin levels.
We aim to determine whether empagliflozin treatment in patients with a recent heart attack has any effects on the heart that are measurable with MRI.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
18/YH/0190
Date of REC Opinion
19 Jun 2018
REC opinion
Further Information Favourable Opinion