Dapagliflozin in Type 2 diabetic patients with diabetic nephropathy.
Research type
Research Study
Full title
A study to investigate the potential renoprotective role of sodium-glucose transporter-2 (SGLT-2) antagonist Dapagliflozin in Type 2 diabetic patients with diabetic nephropathy
IRAS ID
126755
Contact name
Janaka Karalliedde
Contact email
Sponsor organisation
King's College London
Eudract number
2013-004042-42
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Purpose of proposed study: We aim to test in a 24 week prospective open label parallel group trial that the combination of Dapagliflozin and Ramipril significantly reduces albuminuria as compared to Ramipril alone in patients with type-2 diabetes (T2DM) being managed according to established standards of care , preserved renal function and residual microalbuminuria despite renin angiotensin aldosterone system (RAAS) blockade.
Diabetes and in particular diabetic renal disease is characterised by activation of the RAAS. Despite the development and increased use of inhibitors of the RAAS, in recent decades there remains an unmet need for novel treatments to address the growing global burden of diabetic renal disease
The objective of the study is investigate if the combination of Dapagliflozin and Ramipril significantly reduces albuminuria as compared to Ramipril alone in patients with T2DM and residual microalbuminuria despite optimal RAAS blockade.
The study will be conducted in T2DM patients aged 35-75 years, with residual albuminuria (defined as two consecutive urine albumin creatinine ratios >3 mg/mmol in the preceding 12 months) on 10mg od of Ramipril or another ACE-inhibitor or angiotensin receptor blocker (ARB) dose equivalent to 10mg od of Ramipril, and estimated GFR >60 ml/min. Patients will be on a stable dose of ACE-inhibitors or ARB in the preceding 3 months.
Albuminuria is an early sign of renal microvascular disease and serves as a bio-marker of renal and vascular injury in diabetes.
The primary endpoint will be change in albuminuria measured by albumin excretion rate and we plan to study 20 patients in Dapagliflozin and Ramipril group and 20 patients in Ramipril treatment group (40 patients in total).
This study will establish if Dapagliflozin treatment provides cardio-renal benefits by potentiation of RAAS blockade with concomitant production of beneficial/protective RAAS metabolites as well reducing intraglomerular pressure that will aid/confer both renal and vascular protection.REC name
London - Westminster Research Ethics Committee
REC reference
14/LO/0148
Date of REC Opinion
18 Mar 2014
REC opinion
Further Information Favourable Opinion