IRB Study Number 24-654
Status Recruiting
Institute Endocrinology and Metabolism Institute
Description
The purpose is to determine the effectiveness and safety of sotagliflozin in slowing kidney function decline in persons with type 1 diabetes and moderate to severe diabetic kidney disease.
Inclusion Criteria
Inclusion criteria:
Male or female, 18 to 75 years of age, inclusive.
T1D continuously treated with insulin started within one year from diagnosis.
Duration of T1D greater than or equal to 8 years at screening;
eGFR based on serum creatinine (2021 CKD-EPI equation)1 between 20 and 60 ml/min/1.73 m2 at screening (if the serum creatinine eGFR is in the 61 to 65 or 16 to 19 range ml/min/1.73 m2, inclusion should be based on the eGFR estimated with the 2021 CKD-EPI serum creatinine-cystatin C equation);1
First morning void urinary albumin/creatinine ratio (UACR) greater than or equal to 200 mg/g at screening (with the option of a second UACR measurement within 2 weeks from the first one if the UACR was in the 150-199 mg/g range; if the repeat UACR is still <200 mg/g, the entire screening process may be repeated after greater than or equal to2 months).
HbA1c at screening <10% (with the option of one re-screen if the first measurement fails to meet the inclusion criterion);
Receiving standard of care, including renin angiotensin system blockade (RASB), 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 CGM device for the entire duration of the study.
Exclusion Criteria
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 2 months prior to screening;
Use of 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 (patients can be rescreened after being on stable dose for 3 months);
Use of anti-TNF-alpha biologic medications at screening;
Known allergies, hypersensitivity, or intolerance to SOTA;
History of greater than or equal to 3 severe hypoglycemic events (requiring third-party assistance for correction) within 3 months of screening;
History of 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 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 renal 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 AST or 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 in the opinion of the investigator;
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 in the opinion of the investigator;
Heavy alcohol use (for men, greater than or equal to 5 drinks on any day or greater than or equal to 15 drinks per week; for women, greater than or equal to 4 drinks on any day or greater than or equal to 8 drinks per week) at screening;
Participation in another interventional clinical research study within 30 days of screening;
Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial;
SBP>155 or DBP >95 mmHg at screening (with the option of two re-screens after initiation or adjustment of anti-hypertensive therapy by the primary care provider, if needed);
Presence of a clinically significant medical history, physical examination, or laboratory finding at screening 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.
