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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
Taking Empagliflozin first
Taking the Empagliflozin in second
CHU Nice - Hôpital Pasteur 2
Nice, Alpes-Maritimes, France
RECRUITINGAnti-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.
Time frame: 20 months
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.
Time frame: 20 months
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).
Time frame: 20 months
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.
Time frame: 20 months
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).
Time frame: 20 months
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eGFR effect by good profile
To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin has a good safety profile (no acute kidney injury or hyperkalaemia \> 5.5 mmol/L or acidosis (serum bicarbonate \<23 mmol/L)),
Time frame: 20 months
eGFR effect by levels
Changes in eGFR levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Time frame: 20 months
eGFR effect by serum potassium
Changes in serum potassium levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Time frame: 20 months
eGFR effect by serum bicarbonate
Changes in serum bicarbonate levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Time frame: 20 months
eGFR effect by albuminuria
Changes in mean 24-hour albuminuria between 3 days running urinary collections at baseline and after starting each treatment period (empagliflozin 10 mg/d and matching placebo).
Time frame: 20 months
Effect on HbA1c
To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin has no significant effect on HbA1c. Changes in HbA1C between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
Time frame: 20 months
Magnitude of eGFR by TEAEs
Describe the magnitude of eGFR decrease following empagliflozin or placebo treatments with the description of treatment emergent adverse events (TEAEs).
Time frame: 20 months
Magnitude of eGFR by SAEs
Describe the magnitude of eGFR decrease following empagliflozin or placebo treatments with the description of serious adverse events (SAEs).
Time frame: 20 months