SugarNSalt
Summary
The purpose of this study is to find out if a drug called sotagliflozin (SOTA) can slow kidney function decline in persons with type 1 diabetes and moderate to severe diabetic kidney disease (defined as greater than 50% reduction in kidney filtering function and the leakage of increased amounts of protein in the urine) and to evaluate DKA risk mitigation protocols for people living with T1D taking SOTA.
SOTA is currently approved in the US to reduce the risk of being admitted to the hospital due to heart failure, or dying of cardiovascular disease, in persons with type 2 diabetes and other conditions. Some studies have shown that drugs like SOTA may also slow progression of kidney disease in persons with type 2 diabetes. However, this has not yet been studied in persons with type 1 diabetes.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 75
Inclusion criteria:
1. Male or female between 18 and 75 years of age
2. Type 1 diabetes
3. Duration of T1D for at least 8 years
4. Has diabetic kidney disease
5. HbA1c at screening less than 10%
6. Willing and able to comply with schedule of events and protocol requirements, and willing to wear a CGM device for the entire duration of the study.
Exclusion criteria:
1. Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease;
2. Use of non-FDA approved automated insulin delivery devices;
3. Use of any SGLT inhibitor in the previous 2 months;
4. 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);
Participate
Additional information
Contact information
Amy Dunlop, RN, MSc, CDE
Principal investigator:
Ronald Sigal
Clinical trial:
Yes
REB-ID:
REB23-1796