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Using Sotagliflozin to Slow Kidney Decline in Type 1 Diabetes Patients

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

PHASE3 · Joslin Diabetes Center · NCT06217302

This study is testing if sotagliflozin can help slow down kidney problems in people with type 1 diabetes and kidney disease.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorJoslin Diabetes Center (other)
Locations19 sites (Stanford, California and 18 other locations)
Trial IDNCT06217302 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of sotagliflozin, a sodium-glucose cotransporter-2 inhibitor, in slowing kidney function decline in individuals with type 1 diabetes and diabetic kidney disease. The study employs a multi-center, double-blind, placebo-controlled design, enrolling 150 participants who meet specific eligibility criteria. An enhanced diabetic ketoacidosis prevention plan will be implemented to mitigate risks associated with the treatment. The trial aims to evaluate the renal benefits of sotagliflozin over a three-year period while ensuring patient safety.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with type 1 diabetes who have been diagnosed for at least eight years and have moderate to advanced diabetic kidney disease.

Not a fit: Patients with type 2 diabetes or those with other forms of diabetes will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly slow the progression of kidney disease in patients with type 1 diabetes, potentially reducing the risk of end-stage kidney disease.

How similar studies have performed: Previous studies have shown promising results with similar approaches in type 2 diabetes, but this specific application in type 1 diabetes is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 a clinically appropriate dose, unless contraindicated or not tolerated.
* Willing and able to comply with schedule of events and protocol requirements, including written informed consent, and willing to wear a continuous glucose monitoring (CGM) device for the entire duration of the study.
* a. Blood pressure ≤155/95 mmHg at screening, or b. BP ≤155/95 mmHg at the end of the run-in period, or c. consistent BP ≤155/95 mmHg on home monitoring during the run-in period, as determined by study site investigator, despite BP values \>155/95 mmHg in clinic.

Exclusion Criteria:

* Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease;
* Use of automated insulin delivery devices that are not approved by health regulatory agencies, or used in ways that do not align with manufacturer recommendations;
* Use of any SGLT inhibitor in the previous 2 months;
* Use of dual medication RASB therapy (spironolactone, eplerenone, finerenone are allowed in combination with RASB therapy);
* Use of GLP-1 receptor agonists and other non-insulin glucose-lowering agents if not on stable dose for \> 2 months at screening (patients can be rescreened after being on stable dose for \> 2 months);
* Use of anti tumor necrosis factor (TNF) alpha biologic medications at screening;
* Known allergies, hypersensitivity, or intolerance to SOTA;
* History of ≥3 severe hypoglycemic events (requiring third-party assistance for correction) within 3 months of screening;
* History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar state within 3 months of screening OR \>1 episode of DKA or non-ketotic hyperosmolar state within 12 months of screening;
* Blood beta-hydroxybutyrate (BHB) \>0.6 mmol/L for \>2 hours on \>2 occasions during the Run-in period;
* Inadequate beta hydroxybutyrate (BHB) testing (\<50% of the prescribed measurements) during Run-in;
* History of primary renal glycosuria;
* History of biopsy-proven non-diabetic chronic kidney disease (CKD);
* History of kidney transplant or currently on chronic dialysis;
* Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and/or known diagnosis of cirrhosis based on liver biopsy, imaging, or elastography, and/or aspartate aminotransferase (AST) or alanine transaminase (ALT) at screening \>2 times upper limit of normal, and/or total bilirubin at screening \>1.3 times upper limit of normal).
* History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status;
* Cancer treatment (excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer) within one year of screening.
* Illicit drug abuse within 6 months of screening;
* Heavy alcohol use (for men, 5 drinks or more on any day or 15 drinks or more per week; for women, 4 drinks or more on any day or 8 drinks or more per week);
* Participation in another interventional clinical research study within 30 days of screening;
* Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial;
* Presence of a clinically significant medical history, physical examination, or laboratory finding that may interfere with any aspect of study conduct or interpretation of results;
* Any condition that may render the patient unable to comply with study requirements and/or complete the study.

Where this trial is running

Stanford, California and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Diabetic Nephropathies, Kidney Failure, Chronic, Diabetes Mellitus Type 1, Heart Failure, Type 1 diabetes, Heart failure, Cardiovascular disease, Glomerular filtration rate

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.