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Phase 3RecruitingNCT06217302

SUGARNSALT: sotagliflozin to slow kidney decline in T1D CKD

What this study tests

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.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-03-24.

Most recent recorded citation date: 2026-03-24. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Adults 18–75 with T1D for at least eight years, insulin since the first year, eGFR 20–60 mL/min/1.73 m², and albuminuria (first-morning UACR at least 200 mg/g, or at least 100 mg/g with additional high-risk features). Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
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.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States, Canada. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • eGFR at the end of an 8-week washout after 3 years of treatment (CKD-EPI creatinine-cystatin C, 2021)

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.

Registry-listed collaborators include Breakthrough T1D, Lexicon, Dexcom and a North American academic network. The registry describes an enhanced ketoacidosis-prevention plan because SGLT inhibitors carry a known risk of DKA at glucose that still looks in range — including below the commonly used 250 mg/dL (13.9 mmol/L) euglycemic-DKA cutoff. 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.

Sources

  1. [1]