Patients with type 2 diabetes are at high risk of developing diabetic nephropathy. The most promising antidiabetic agents on the market with potential to preserve renal function are endogenous glucagon like peptide (GLP-1) agonists and selective sodium-glucose cotransporter 2 (SGLT2) inhibitors. Combination treatment with empagliflozin 25 mg and semaglutide 1.34 mg/ml might have a beneficial effect on albuminuria (UACR), HbA1c, kidney function, 24 hour blood pressure, and markers of inflammation and endothelial dysfunction.
The primary objective is to evaluate the effect of treatment with semaglutide 1.34 mg/ml in combination with empagliflozin 25 mg, compared to treatment with empagliflozin 25 mg in combination with placebo on albuminuria in participants with type 2 diabetes and albuminuria.
In a randomised, double blinded, placebo controlled, parallel, single center study, we include 80 participants with type 2 diabetes and albuminuria. During a run-in period of 26 weeks participants will be treated with empagliflozin. After the run-in period, they will be randomized 1:1 to active treatment or placebo for a period of 26 weeks. The primary endpoint is change in albuminura from randomization to week 52 measured in three morning spot urine samples.
Previous studies have mainly focused on glycaemic parameters when combining a GLP-1 agonist and SGLT2 inhibitor. From a renal perspective, it is of major interest to investigate if a stepwise initiation of semaglutide or placebo added to ongoing empagliflozin therapy would complement or have an additive effect on renal parameters.
Novo Nordisk A/S.