SOPHIST: sotagliflozin for heart-failure symptoms in T1D
Recruiting UK Phase 2 of 16 weeks of sotagliflozin 200 mg daily versus placebo in adults with Type 1 diabetes and heart failure or high risk of heart failure. The primary endpoint is a heart-failure quality-of-life score, not HbA1c. No results.
Primary endpoints
- Change in Kansas City Cardiomyopathy Questionnaire clinical summary score at 16 weeks
Results so far
No results. Recruiting; estimated n=320; actual start 28 January 2025; estimated primary and study completion 31 October 2027. Last registry update 6 April 2026. Type 2 heart-failure sotagliflozin data do not score this Type 1 trial.
The full picture
SOPHIST is a Type 1-only heart-failure symptoms trial of sotagliflozin, funded with Lexicon and JDRF (Breakthrough T1D) involvement. It does not test a Type 1 glucose licence. The question is whether 16 weeks of 200 mg daily improves how people with T1D and heart failure feel, on the Kansas City Cardiomyopathy Questionnaire.
Participants must already use CGM or start one. Ketoacidosis remains the reason this class lost its European Type 1 indication: ketones can rise while glucose still reads in a typical target such as 70–180 mg/dL (3.9–10.0 mmol/L). No results are posted.