SUGARNSALT: sotagliflozin to slow kidney decline in T1D CKD
Recruiting US/Canada Phase 3 of three years of sotagliflozin 200 mg daily versus placebo in adults with longstanding T1D and moderate-to-severe diabetic kidney disease, with an enhanced DKA-prevention plan. Primary endpoint is washout eGFR, not glucose. No results.
Primary endpoints
- eGFR at the end of an 8-week washout after 3 years of treatment (CKD-EPI creatinine-cystatin C, 2021)
Results so far
No results. Recruiting; estimated n=150; actual start 31 October 2024; estimated primary completion December 2028 and completion May 2029. Last registry update 24 March 2026. This is not STENO1, and it is not a Type 1 licence. DKA remains the class-defining risk.
The full picture
SUGARNSALT asks whether sotagliflozin, already used for heart failure in other populations, slows kidney-function loss in Type 1 diabetes with established CKD. The primary readout is eGFR after the drug has been washed out, so an acute dip in filtration does not masquerade as protection.
Collaborators include Breakthrough T1D, Lexicon, Dexcom and a North American academic network. The protocol includes an enhanced ketoacidosis-prevention plan because SGLT inhibitors can cause DKA at glucose that still looks in range — including below 250 mg/dL (13.9 mmol/L). A recruiting kidney-outcome trial is not an approval, and it is not the STENO1 DKA-incidence package Lexicon has cited for a possible US Type 1 resubmission.