SUGAR-DM-HF
Research type
Research Study
Full title
StUdies of empaGliflozin and its cArdiovascular, Renal and metabolic effects in patients with Diabetes Mellitus and Heart Failure (SUGAR-DM-HF)
IRAS ID
214100
Contact name
Naveed Sattar
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Eudract number
2016-003719-37
Duration of Study in the UK
2 years, 8 months, 31 days
Research summary
Empagliflozin has been approved for the treatment of type 2 diabetes. A recent large study suggested that empagliflozin was also very beneficial for the heart and kidneys. The reason for this is unclear, but we suspect that a strong diuretic effect of the drug (the drug acts like a “water tablet” making patients pass more urine) may partly explain its benefit, and particularly benefit people with diabetes and heart failure.
It is important to understand how empagliflozin works in more detail so that the drug can be targeted to the patients that might benefit the most. We have designed a comprehensive clinical trial to study the effects of empagliflozin on the heart, kidneys and metabolism of the body, in patients with diabetes and heart failure.
The study will be carried out in a single large central teaching hospital, Queen Elizabeth University Hospital, Glasgow. A total of 130 eligible patients will be recruited through outpatient clinics in NHS GG&C hospitals, nurse services, and through targeted invitation identifying patients through General Practice records.
Each patient will be invited to visits at weeks 0, 2 (brief safety visit), 12, 36 and 40. Patients will stop the study medication at week 36, and we will check for any persistent effects at week 40. We will phone patients at week 24 to ensure their wellbeing.
We will perform blood and urine tests, electrocardiogram (record electrical activity of the heart), ultrasound (heart, lungs), MRI (heart, kidneys) (only at weeks 0, 36 and 40), assess their ability to exercise, and ask a few questions about their quality of life.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
17/NE/0118
Date of REC Opinion
12 Jun 2017
REC opinion
Further Information Favourable Opinion