The proximal tubule remains the main site for sodium reabsorption in patients with advanced renal failure. The investigators therefore hypothesize that SGLT2i should still exert a significant natriuretic effect in patients with eGFR below 20 ml/min/1.73m2, and therefore should still decrease proteinuria with a potential renal protective effect.
type 2 diabetics,
age between 18 and 80 years,
RAS blockade at maximal tolerated dosage for 1 month,
eGFR (CKD-EPI) between 10 and 20 ml/min/1.73m2,
any medical condition that, in the opinion of the investigator makes the participant not suitable for inclusion,
history of ketoacidosis in the past while on empagliflozin or any other SGLT2i class drugs,
participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening,
known hypersensitivity or intolerance to empagliflozin or any of the excipients of the product,
Crossover
Empagliflozin 10 MG then Placebo
DrugTaking Empagliflozin first
Placebo then Empagliflozin 10 MG
DrugTaking the Empagliflozin in second
Anti-proteinuric effect
Changes in mean UACR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo). To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, SGLT2i exerts a clinically significant anti-proteinuric effect.
Body weight effect
Changes in body weight between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo. To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin acutely decreases body weight.
Urinary sodium effect
To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin: increases urinary sodium excretion. Changes in mean UPCR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Urinary volume effect
To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin: increases urinary volume. Changes in mean 24-hour urinary.
Blood pressure effect
To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin: decreases ambulatory blood pressure. Changes in mean ambulatory systolic blood pressure between 3 days running baseline and 3 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
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Centre Hospitalier Universitaire de Nice
Lead sponsor
Boehringer Ingelheim
Collaborator
