Empagliflozin for Type 2 diabetes|Chronic kidney disease (eGFR 10-20 ml/min/1.73 m2)

Inclusion criteria

• {"criterion_text":"- Type 2 diabetics.\n- Age between 18 and 80 years.\n- RAS (renin angiotensin system) blockade at maximal tolerated dosage for 1 month.\n- eGFR (CKD-EPI) between 10 and 20 ml/min/1.73m2\n- UACR (urinary albumin creatinine ratio) > 300mg/g creatinine and UPCR (urinary protein creatinine ratio) > 500mg/g creatinine\n- Office systolic blood pressure > 110 mmHg\n- Stable dosage of antihypertensive drugs and diuretics for 1 month\n- For women of child-bearing age, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used For more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed."}

Exclusion criteria

• {"criterion_text":"- Any medical condition that, in the opinion of the investigator, makes the participant not suitable for inclusion\n- Description of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).\n- History of ketoacidosis in the past while on empagliflozin or any other SGLT2i class drugs\n- Participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening.\n- Known hypersensitivity or intolerance to empagliflozin or any of the excipients of the product\n- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.\n- No social insurance\n- Unwilling to give informed consent, vulnerable persons (minors, adults under guardianship or trusteeship, pregnant women, persons deprived of their liberty, persons unable to speak French).\n- Changes in serum bicarbonate levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).\n- Changes in HbA1C between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo)."}

Primary endpoints

• {"endpoint_text":"- 1/ 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). 2/ 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).","definition_or_measurement_approach":"Changes measured on spot morning urine samples comparing two consecutive days at baseline versus two consecutive days at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo)."}

Secondary endpoints

• {"endpoint_text":"- 1/Changes in body weight between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).\n- 2/a) Changes in mean 24-hour urinary sodium excretion and urinary volume between 3 days running urinary collections at baseline and 3 days after starting each treatment period (empagliflozin 10 mg/d and matching placebo). The measures will be the mean of each 3 days period.\n- 2/b) 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),\n- 2/c) Changes in serum potassium levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo), changes in serum bicarbonate levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).\n- 2/d) Description of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), (no acute kidney injury or hyperkalaemia > 5.5 mmol/L or acidosis (serum bicarbonate <23 mmol/L))\n- 3/ Changes in HbA1C between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).\n- 4/ To show that mean 24-hour albuminuria decreases in the empagliflozine group compare to placebo group in the 3 days following the beginning of the treatment compare to the 3 days before. The measures will be the mean of each 3 days period","definition_or_measurement_approach":"Measures defined in each endpoint text: body weight change from baseline to end of each 6-week period; 24-hour urinary sodium and volume averaged over 3-day collections; ambulatory systolic BP averaged over 3 days; weekly serum potassium and bicarbonate measures during each 6-week period; safety described as TEAEs/SAEs with thresholds (no AKI, hyperkalaemia >5.5 mmol/L, acidosis serum bicarbonate <23 mmol/L); HbA1c change baseline to end of each 6-week period; 24-hour albuminuria averaged over 3-day periods before and after treatment start."}

France

Earliest CTIS Part Ii Submission Date

02-02-2026

Latest Decision Or Authorization Date

05-03-2026

Processing Time Days

31

Number Of Sites

1

Number Of Participants

34

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nice

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France