NCT06217302 · Alessandro Doria
Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
(SUGARNSALT)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Sotagliflozin
Oral sotagliflozin (200 mg per day)
DRUG
Placebo
Inactive tablets identical to sotagliflozin tablets
Primary outcome measures
eGFR at the end of the wash-out period following the treatment period
Time frame: End of the 2-month wash-out period following the 3-year treatment period (weeks 162 and 164)
eGFR at the end of the 8-week drug washout period following the 3-year treatment period, estimated from Central Lab serum creatinine and cystatin C using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation and adjusted by its baseline value. Baseline and end-of-washout eGFRs will be considered as the average of two eGFR values taken on two separate days before randomization (V2 and V4) and after the washout (V18 and V19), respectively.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Type1 diabetes (T1D) continuously treated with insulin within one year from diagnosis.
- Duration of T1D ≥ 8 years;
- eGFR based on serum creatinine and cystatin c (2021 serum creatinine-cystatin C CKD-EPI equation) between 20 and 60 ml/min/1.73 m2 at screening (with the option of a second eGFR measurement within 4 weeks from the first one if the eGFR was in the range of \>60 to ≤65 or ≥16 to \<20 ml/min/1.73 m2);
- a. First morning void urinary albumin creatinine ratio (UACR) ≥200 mg/g at Screening or on repeat measurement within 4 weeks from the first one, or b. First morning void urinary UACR ≥100 mg/g at Screening or on repeat measurement within 4 weeks and at least one uACR \>=30 in the previous 2 years while treated with RASB at a stable dose;
- HbA1c at screening \<10% (with the option of a second HbA1c measurement within 4 weeks from the first one if the HbA1c was ≤10.2%);
- Receiving standard of care, including renin angiotensin system blockers (RASB) at
Where
- Stanford, California
- Aurora, Colorado
- Orlando, Florida
- Chicago, Illinois
- Boston, Massachusetts
- St Louis, Missouri
- Syracuse, New York
- The Bronx, New York
- Cleveland, Ohio
- Portland, Oregon
- Dallas, Texas
- Seattle, Washington
And 1 more location — see the full list below.
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
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 24, 2026 · Source of record for eligibility and locations