🏛️ Verified NIH Record • Updated 2026-03-20

Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease (NCT06217302)

Effectiveness and Safety of Sotagliflozin in Slowing Kidney Function Decline in Persons With Type 1 Diabetes and Moderate to Severe Diabetic Kidney Disease

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Alessandro Doria

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Stanford University Medical Center — Stanford, California

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (19 Sites)

  • Stanford University Medical Center — Stanford, California
  • Barbara Davis Center / University of Colorado Denver — Aurora, Colorado
  • AdventHealth — Orlando, Florida
  • Northwestern University Feinberg School of Medicine — Chicago, Illinois
  • Joslin Diabetes Center — Boston, Massachusetts
  • Washington University — St Louis, Missouri
  • SUNY Upstate Medical University — Syracuse, New York
  • Albert Einstein College of Medicine / Montefiore Medical Center — The Bronx, New York
  • Cleveland Clinic Foundation — Cleveland, Ohio
  • Oregon Health and Science University — Portland, Oregon
  • University of Texas Southwestern — Dallas, Texas
  • University of Washington — Seattle, Washington
  • Providence Sacred Heart Medical Center — Spokane, Washington
  • Unversity of Calgary — Calgary, Alberta
  • Alberta Diabetes Institute — Edmonton, Alberta
  • St. Paul's Hospital — Vancouver, British Columbia
  • LMC Diabetes and Endocrinology — Toronto, Ontario
  • Toronto General Hospital — Toronto, Ontario
  • Institut de Recherches Cliniques de Montréal — Montreal, Quebec

📞 Contact the Study Coordinator

Phone: (617) 334-2257

Email: christine.mendonca@joslin.harvard.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗