Type 2 Diabetes With Renal Manifestations Clinical Trial
Official title:
Renal Effects of Treatment With Empagliflozin Alone or in Combination With Semaglutide in Patients With Type 2 Diabetes and Albuminuria - A Double Blinded, Randomised, Placebo Controlled, Parallel, Single Center Study
The objective of this study 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, placebo-controlled, double-blinded, parallel trial we will include 80
patients with type 2 diabetes and albuminuria. Patients will start in a run-in phase of 26
weeks with empagliflozin 25 mg alone. After that, the patients will be randomised 1:1 to an
active treatment period with semaglutide of 26 weeks or placebo for 26 weeks.
The primary endpoint is change from randomisation to week 52 in albuminuria, measured in
three morning urine samples.
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. The LEADER trial demonstrated that treatment with liraglutide (GLP-1
agonist) resulted in 22% lower risk of renal composite outcome. The EMPA-REG trial
demonstrated that treatment with empagliflozin (SGLT2 inhibitor) reduced the same renal
composite outcome by 39%.
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.
In a randomised, placebo-controlled, double-blinded, parallel trial we will include 80
patients with type 2 diabetes and albuminuria. Patients will start in a run-in phase of 26
weeks with empagliflozin 25 mg alone. After that, the patients will be randomised 1:1 to an
active treatment period with semaglutide of 26 weeks or placebo for 26 weeks.
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