Testing Sotagliflozin against a placebo for diabetic nephropathies

Exclusion

• −Known allergies, hypersensitivity, or intolerance to SOTA;
• −History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status;
• −Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease;
• −Use of automated insulin delivery devices that are not approved by health regulatory agencies, or used in ways that do not align with manufacturer recommendations;
• −Use of any SGLT inhibitor in the previous 2 months;
• −Use of dual medication RASB therapy (spironolactone, eplerenone, finerenone are allowed in combination with RASB therapy);
• −Use of GLP-1 receptor agonists and other non-insulin glucose-lowering agents if not on stable dose for \> 2 months at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → (patients can be rescreened after being on stable dose for \> 2 months);
• −Use of anti tumor necrosis factor (TNF) alpha biologic medications at screening;
• −History of ≥3 severe hypoglycemic events (requiring third-party assistance for correction) within 3 months of screening;
• −History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar state within 3 months of screening OR \>1 episode of DKA or non-ketotic hyperosmolar state within 12 months of screening;
• −Blood beta-hydroxybutyrate (BHB) \>0.6 mmol/L for \>2 hours on \>2 occasions during the Run-in periodRun-in periodA short trial period before the study proper begins.Read more →;
• −Inadequate beta hydroxybutyrate (BHB) testing (\<50% of the prescribed measurements) during Run-in;
• −History of primary renal glycosuria;
• −History of biopsy-proven non-diabetic chronic kidney disease (CKD);
• −History of kidney transplant or currently on chronic dialysis;
• −Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and/or known diagnosis of cirrhosis based on liver biopsy, imaging, or elastography, and/or aspartate aminotransferase (AST) or alanine transaminase (ALT) at screening \>2 times upper limit of normal, and/or total bilirubin at screening \>1.3 times upper limit of normal).
• −Cancer treatment (excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer) within one year of screening.
• −Illicit drug abuse within 6 months of screening;
• −Heavy alcohol use (for men, 5 drinks or more on any day or 15 drinks or more per week; for women, 4 drinks or more on any day or 8 drinks or more per week);
• −Participation in another interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical research study within 30 days of screening;
• −Presence of a clinically significant medical history, physical examination, or laboratory finding that may interfere with any aspect of study conduct or interpretation of results;
• −Any condition that may render the patient unable to comply with study requirements and/or complete the study.
• −Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial;