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NCT06217302 · ClinicalTrials.gov record · last posted 2026-03-24

Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease

Study acronym: SUGARNSALT
StatusRecruiting
PhasePhase 3
Started2024-10-31
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from the ClinicalTrials.gov record
Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.

Amendment record 10 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 10 times since 2024-01-18; most recent amendment 2026-03-20. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-11-25
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT06217302
Lead Sponsor Alessandro Doria
Collaborators: Canadian Institutes of Health Research (CIHR), The Kidney Foundation of Canada, The Cleveland Clinic, University of Michigan, University of Colorado, Denver, Northwestern University, Washington University School of Medicine, State University of New York - Upstate Medical University, Providence Medical Research Center, Stanford University, Montefiore Medical Center, University of Toronto, University Health Network, Toronto, University of Calgary, University of Alberta, University of British Columbia, Institut de Recherches Cliniques de Montreal, LMC Diabetes & Endocrinology Ltd., Joslin Diabetes Center, Lexicon Pharmaceuticals, DexCom, Inc., University of Washington, Breakthrough T1D, AdventHealth
Conditions Diabetic Nephropathies, Kidney Failure, Chronic, Diabetes Mellitus Type 1, Heart Failure
Enrollment 150 participants
Start Date 2024-10-31
Primary Completion 2028-12 (estimated)
Study Completion 2029-05 (estimated)
Updated on ClinicalTrials.gov 2026-03-24