Recruiting
Phase 3

Sotagliflozin

Sponsor:

Alessandro Doria

Code:

NCT06217302

Conditions

Diabetic Nephropathies

Kidney Failure, Chronic

Diabetes Mellitus Type 1

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Sotagliflozin

Placebo

Study Details

Brief summary:

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.

Conditions

Diabetic Nephropathies

Kidney Failure, Chronic

Diabetes Mellitus Type 1

Heart Failure

Study ID

NCT06217302

Start date

Oct 31, 2024

Status verified date

Mar, 2026

Completion date

May, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Sotagliflozin

Oral sotagliflozin at a dose of 200 mg (one tablet) per day for three years followed by a 2-month wash-out period.

placebo comparator: Placebo

Oral tablets similar to sotagliflozin tablets but containing no active drug (one tablet per day for three years followed by a 2-month wash-out period).

Interventions

Sotagliflozin

Oral sotagliflozin (200 mg per day)

Placebo

Inactive tablets identical to sotagliflozin tablets

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Christine Mendonca

617-334-2257christine.mendonca@joslin.harvard.edu

Alexis Puthussery

617-975-8235aputhuss@joslin.harvard.edu

Locations

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94305

Contacts

Grace Deala

gdeala@stanford.edu

Arati Nagarkar, MD

arati.nagarkar@stanford.edu

Principal Investigator:

Marina Basina, MD

Barbara Davis Center / University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Matthew Klein, BA

Matthew.P.Klein@cuanschutz.edu

Scott Maclean

Scott.2.maclean@cuanschutz.edu

Principal Investigator:

Sarit Polsky, MD

AdventHealth

Recruiting

Orlando, Florida, United States, 32803

Contacts

Ivette Moreno

Ivette.Moreno@AdventHealth.com

Principal Investigator:

Tina Thethi

Northwestern University Feinberg School of Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Marianna Colucci

marianna.colucci@northwestern.edu

Christina Coventry, MSN RN

christina.coventry@northwestern.edu

Principal Investigator:

Amisha Wallia, MD

Joslin Diabetes Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christine Mendonca

617-334-2257christine.mendonca@joslin.harvard.edu

Principal Investigator:

Alessandro Doria, MD PhD MPH

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Heather Schaefer

hschaefer@wustl.edu

Principal Investigator:

Janet McGill, MD

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Jane Bulger, MS, CCRC

315-464-9008BulgerJ@upstate.edu

Susan Bzdick

bzdicks@upstate.edu

Principal Investigator:

Ruth Weinstock, MD

Albert Einstein College of Medicine / Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Cynthia Rivera, BS

cynthia.rivera@einsteinmed.edu

Sally Duran, BA

sally.duran@einsteinmed.edu

Principal Investigator:

Matthew Abramowitz, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Kelly Paulus

PAULUSK2@ccf.org

Maya Boyd

BOYDA5@ccf.org

Principal Investigator:

Luiza Caramori, MD PhD

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Alyssa Carlson

carlsaly@ohsu.edu

Krista Metas, RN

metas@ohsu.edu

Principal Investigator:

Rodica Busui, MD, PhD

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Lina Gonzalez Duarte

Lina.GonzalezDuarte@UTSouthwestern.edu

Jovana Valdez

Jovana.Valdez@UTSouthwestern.edu

Principal Investigator:

Ildiko Lingvay, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98105

Contacts

Anjali Kumari

anjalikr@uw.edu

Bri Hihara

bhihara@uw.edu

Principal Investigator:

Petter Bjornstad, MD

Providence Sacred Heart Medical Center

Recruiting

Spokane, Washington, United States, 99204

Contacts

Nicole Maser

Nicole.maser@providence.org

Principal Investigator:

Katherine R. Tuttle, MD

Unversity of Calgary

Recruiting

Calgary, Alberta, Canada, T2T 5C7

Contacts

Jenny Schulz

jennifer.schulz@ucalgary.ca

Michelle Smith, RN

mahunter@ucalgary.ca

Principal Investigator:

Ronald Sigal, MD MPH

Alberta Diabetes Institute

Recruiting

Edmonton, Alberta, Canada, T6G 2E1

Contacts

Dominique Forrest

dforres1@ualberta.ca

Jyoti Singh

jyoti1@ualberta.ca

Principal Investigator:

Peter Senior, MD

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Paula Macleod

pmacleod@providencehealth.bc.ca

Principal Investigator:

Adeera Levin, MD

LMC Diabetes and Endocrinology

Recruiting

Toronto, Ontario, Canada, M4G 3E8

Contacts

Lydia Beaudette

Lydia.Beaudette@clinsurge.ca

Arlene Vinas

Arlene.Vinas@ElevateResearch.ca

Principal Investigator:

Ronnie Aronson, MD

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Vesta Lai, RN

416-586-4800Vesta.Lai@uhn.ca

Cheng Xu

416-586-4800Cheng.Xu@uhn.ca

Principal Investigator:

David Cherney, MD

Institut de Recherches Cliniques de Montréal

Recruiting

Montreal, Quebec, Canada, H2W 1R7

Contacts

Roxane St Amand

roxane.st-amand@ircm.qc.ca

Marie Raffray

marie.Raffray@ircm.qc.ca

Principal Investigator:

Remi Rabasa-Lhoret, MD

More Information

Sponsor

Alessandro Doria

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

  • Diabetic Nephropathies
  • Kidney Failure, Chronic
  • Type 1 diabetes
  • Heart failure
  • Cardiovascular disease
  • Glomerular filtration rate
  • SGLT2 inhibitors
  • Diabetic kidney disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by Alessandro Doria on 2026-03-24.