Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease

Launched by ALESSANDRO DORIA · Jan 18, 2024

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ClinConnect Summary

This clinical trial is studying a new medication called sotagliflozin (SOTA) to see if it can help slow down kidney damage in people with type 1 diabetes (T1D) who also have diabetic kidney disease. The goal is to find out if SOTA is effective and safe for these patients, as existing treatments for type 2 diabetes have not been thoroughly tested in those with T1D. The study will include 150 participants who will be monitored closely with a program designed to prevent a serious complication known as diabetic ketoacidosis (DKA). Participants will take either the SOTA medication or a placebo (an inactive pill) daily for three years, and neither they nor the study team will know which one they are taking until the end of the trial.

To be eligible for this study, participants should have been diagnosed with type 1 diabetes for at least eight years and have certain kidney function levels. They need to be willing to follow the study guidelines, including using a continuous glucose monitor to track their blood sugar. Throughout the trial, participants will receive educational support and regular check-ups to ensure their safety. If successful, this study could lead to new treatment options for preserving kidney function in patients with type 1 diabetes and diabetic kidney disease.

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Eligibility criteria

• Inclusion Criteria:
• • Type1 diabetes (T1D) continuously treated with insulin within one year from diagnosis.
• • Duration of T1D ≥ 8 years;
• • eGFR based on serum creatinine and cystatin C between 20 and 60 ml/min/1.73 m2 at screening;
• • First morning void urinary albumin/creatinine ratio (UACR) ≥200 mg/g at screening;
• • HbA1c \<10% at screening;
• • Receiving standard of care, including renin angiotensin system blockers (RASB) at a clinically appropriate dose, unless contraindicated or not tolerated.
• • Willing and able to comply with schedule of events and protocol requirements, including written informed consent, and willing to wear a continuous glucose monitoring (CGM) device for the entire duration of the study.
• Exclusion Criteria:
• • Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease;
• • Use of non-FDA approved automated insulin delivery devices;
• • 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 glucagon-like peptide (GLP-1) receptor agonists and other non-insulin glucose lowering agents if in use for less than 3 months and/or not on stable dose at screening;
• • Use of anti tumor necrosis factor (TNF) alpha biologic medications at screening;
• • Known allergies, hypersensitivity, or intolerance to SOTA;
• • 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 period;
• • 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).
• • History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status;
• • 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 interventional clinical research study within 30 days of screening;
• • Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial;
• • Systolic blood pressure \>155 mmHg or diastolic blood pressure \>95 mmHg at 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.