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Sotagliflozin for Kidney Function in Type 1 Diabetes and Diabetic Kidney Disease

This study is testing if a medication called sotagliflozin can help slow down kidney function decline in people with type 1 diabetes and diabetic kidney disease. Currently, similar drugs are available for type 2 diabetes, but more research is needed for type 1 diabetes due to concerns about a serious complication called diabetic ketoacidosis (DKA). This study aims to enroll 150 participants aged 18 to 75 who have had type 1 diabetes for at least 8 years and have specific kidney function levels (eGFR between 20 and 60 ml/min/1.73 m2). Participants will receive either sotagliflozin or an inactive placebo. The main goal is to see how kidney function (eGFR) changes after a 3-year treatment period and a 2-month wash-out period. The study's status is currently unclear.

Study design
This is an interventional study with a planned enrollment of 150 participants. Participants will receive either the study drug, sotagliflozin, or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 2 months after a 3-year treatment period to measure their kidney function.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06217302

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

Recruiting
PHASE3Ages 18–75InterventionalPrevention
Alessandro Doria
~150 participants
Updated 2026-03-24 on ClinicalTrials.gov
What's tested:SotagliflozinPlacebo

At a glance

Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
eGFR at the end of the wash-out period following the treatment period
Measured over End of the 2-month wash-out period following the 3-year treatment period (weeks 162 and 164)

Conditions

Diabetic Nephropathies
Kidney Failure, Chronic
Diabetes Mellitus Type 1
Heart Failure

Explore related trials

Diabetic NephropathyType 1 Diabetes Mellitus

Where it's being run

19 sites across 15 states
New York2
Washington2
Alberta2
Ontario2
California1
Colorado1
Florida1
Illinois1

Study leadership

  • Alessandro Doria, MD PhD MPH · PRINCIPAL_INVESTIGATOR · Joslin Diabetes Center
  • Michael Mauer, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota
  • David Cherney, MD PhD · PRINCIPAL_INVESTIGATOR · University of Toronto

Who to contact

Christine Mendonca
[email protected]
617-334-2257
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • eGFR at the end of the wash-out period following the treatment periodEnd 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.