Patients with renal impairment and type 2 diabetes.
Conditions
Brief summary
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).
Detailed description
1/Changes in body weight between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo)., 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., 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),, 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)., 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)), 3/ Changes in HbA1C between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo)., 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
Interventions
DRUGJardiance 10 mg film-coated tablets
DRUGPlacebo is identical in composition to empagliflozin but does not contain the iSGLT2 active substance.
Sponsors
Centre Hospitalier Universitaire De Nice
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1/Changes in body weight between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo)., 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., 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),, 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)., 2/d) Description of treatment emergent adverse events (TEAEs) and serious adverse event | — |
Outcome results
None listed