Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
NCT ID: NCT06217302
Last Updated: 2025-09-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
150 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-10-31
Study Completion Date
2029-05-31
Brief Summary
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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.
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Detailed Description
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Despite improvements in glycemia management and the use of renin-angiotensin system blockade (RASB), the overall incidence of ESKD incidence in the US T1D population is not decreasing. For patients with type 2 diabetes (T2D), powerful new drugs that can prevent or delay ESKD, sodium-glucose cotransporter-2 inhibitors (SGLT2i), are now available. Whether similar results can be achieved in T1D remains unknown because of the paucity of studies in this population, due to concerns about the 2- to 3-fold increase in risk of diabetic ketoacidosis (DKA) associated with SGLT2i therapy in T1D. One of the few T1D studies conducted to date (inTandem, a sotagliflozin \[SOTA\] trial), showed that implementation of an enhanced DKA risk monitoring and mitigation strategy can reduce DKA incidence to \<1%/year in subjects on 200 mg/day of this dual SGLT1 and SGLT2 inhibitor. The goals of the present study are to evaluate the renal effectiveness of SGLT2i in T1D and to better understand the benefit/risk ratio of SOTA in T1D persons with moderate to advanced diabetic kidney disease (DKD) - two goals that are warranted and critical given the high risk of death and ESKD in this population. The study, carried out by the Preventing Early Renal Loss (PERL) and the Canadian Institute of Health Research (CIHR)-funded SUGARNSALT (S\&S) consortia, is a multi-center, double-blind, placebo-controlled, parallel-group randomized clinical trial in 150 patients with T1D and moderate to advanced diabetic kidney disease (estimated glomerular filtration rate \[eGFR\] 20-60 ml/min/1.73 m2 and ACR\>200 mg/g). After a 2-month run-in period, during which diabetes care is standardized and education on monitoring and minimizing DKA implemented, eligible study subjects are randomized in a 1:1 ratio to receive placebo or once daily 200 mg SOTA for 3 years followed by a 2-month wash-out period. The eGFR at the end of the wash-out adjusted by its baseline value will be used as the primary outcome on which SOTA efficacy on DKD progression will be evaluated. An intensive DKA risk mitigation plan will be implemented based on the inTandem enhanced protocol as well as on the STICH (Stop SGLT2i, Insulin administration, Carbohydrate intake, Hydration) and STOP-DKA protocols. Cornerstones of this plan will be enhanced participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body (beta-hydroxybutyrate \[BHB\]) self-monitoring. If successful, the present study will provide efficacy and safety data that could be used to seek FDA and Health Canada approval of SOTA for a T1D DKD indication. Based on the available data in T1D, it can be conservatively postulated that SOTA may reduce eGFR loss by 2 ml/min/1.73 m2 per year. Depending on the baseline eGFR, this would translate to a 5-10 year delay of ESKD. The reduction in morbidity and mortality resulting from the prevention or delay of ESKD due to the use of SOTA would have a major impact on the lives of T1D patients with significant DKD as well as on society at large, substantially reducing the human and financial costs associated with this condition.
Conditions
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Diabetic Nephropathies
Kidney Failure, Chronic
Diabetes Mellitus Type 1
Heart Failure
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Sotagliflozin
Oral sotagliflozin at a dose of 200 mg (one tablet) per day for three years followed by a 2-month wash-out period.
Group Type
ACTIVE_COMPARATOR
Sotagliflozin
Intervention Type
DRUG
Oral sotagliflozin (200 mg per day)
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).
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Inactive tablets identical to sotagliflozin tablets
Interventions
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Sotagliflozin
Oral sotagliflozin (200 mg per day)
Intervention Type
DRUG
Placebo
Inactive tablets identical to sotagliflozin tablets
Intervention Type
DRUG
Other Intervention Names
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INPEFA
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Sponsor Role
collaborator
The Kidney Foundation of Canada
OTHER
Sponsor Role
collaborator
The Cleveland Clinic
OTHER
Sponsor Role
collaborator
University of Michigan
OTHER
Sponsor Role
collaborator
University of Colorado, Denver
OTHER
Sponsor Role
collaborator
Northwestern University
OTHER
Sponsor Role
collaborator
Washington University School of Medicine
OTHER
Sponsor Role
collaborator
State University of New York - Upstate Medical University
OTHER
Sponsor Role
collaborator
Providence Medical Research Center
OTHER
Sponsor Role
collaborator
Stanford University
OTHER
Sponsor Role
collaborator
Montefiore Medical Center
OTHER
Sponsor Role
collaborator
University of Toronto
OTHER
Sponsor Role
collaborator
University Health Network, Toronto
OTHER
Sponsor Role
collaborator
University of Calgary
OTHER
Sponsor Role
collaborator
University of Alberta
OTHER
Sponsor Role
collaborator
University of British Columbia
OTHER
Sponsor Role
collaborator
Institut de Recherches Cliniques de Montreal
OTHER
Sponsor Role
collaborator
LMC Diabetes & Endocrinology Ltd.
OTHER
Sponsor Role
collaborator
Joslin Diabetes Center
OTHER
Sponsor Role
collaborator
Lexicon Pharmaceuticals
INDUSTRY
Sponsor Role
collaborator
DexCom, Inc.
INDUSTRY
Sponsor Role
collaborator
University of Washington
OTHER
Sponsor Role
collaborator
Breakthrough T1D
OTHER
Sponsor Role
collaborator
Alessandro Doria
OTHER
Sponsor Role
lead
Responsible Party
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Alessandro Doria
Senior Investigator and Professor of Medicine
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Alessandro Doria, MD PhD MPH
Role: PRINCIPAL_INVESTIGATOR
Joslin Diabetes Center
Michael Mauer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
David Cherney, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Stanford University Medical Center
Stanford, California, United States
Site Status
RECRUITING
Barbara Davis Center / University of Colorado Denver
Aurora, Colorado, United States
Site Status
RECRUITING
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Site Status
RECRUITING
Joslin Diabetes Center
Boston, Massachusetts, United States
Site Status
RECRUITING
Washington University
St Louis, Missouri, United States
Site Status
RECRUITING
SUNY Upstate Medical University
Syracuse, New York, United States
Site Status
RECRUITING
Albert Einstein College of Medicine / Montefiore Medical Center
The Bronx, New York, United States
Site Status
RECRUITING
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Site Status
RECRUITING
Oregon Health and Science University
Portland, Oregon, United States
Site Status
RECRUITING
University of Texas Southwestern
Dallas, Texas, United States
Site Status
RECRUITING
University of Washington
Seattle, Washington, United States
Site Status
RECRUITING
Providence Sacred Heart Medical Center
Spokane, Washington, United States
Site Status
RECRUITING
Unversity of Calgary
Calgary, Alberta, Canada
Site Status
RECRUITING
Alberta Diabetes Institute
Edmonton, Alberta, Canada
Site Status
RECRUITING
St. Paul's Hospital
Vancouver, British Columbia, Canada
Site Status
RECRUITING
LMC Diabetes and Endocrinology
Toronto, Ontario, Canada
Site Status
RECRUITING
Toronto General Hospital
Toronto, Ontario, Canada
Site Status
RECRUITING
Institut de Recherches Cliniques de Montréal
Montreal, Quebec, Canada
Site Status
RECRUITING
Countries
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United States
Canada
Central Contacts
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Facility Contacts
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References
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van Raalte DH, Bjornstad P, Persson F, Powell DR, de Cassia Castro R, Wang PS, Liu M, Heerspink HJL, Cherney D. The Impact of Sotagliflozin on Renal Function, Albuminuria, Blood Pressure, and Hematocrit in Adults With Type 1 Diabetes. Diabetes Care. 2019 Oct;42(10):1921-1929. doi: 10.2337/dc19-0937. Epub 2019 Aug 1.
Reference Type
BACKGROUND
Bhatt DL, Szarek M, Pitt B, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Inzucchi SE, Kosiborod MN, Cherney DZI, Dwyer JP, Scirica BM, Bailey CJ, Diaz R, Ray KK, Udell JA, Lopes RD, Lapuerta P, Steg PG; SCORED Investigators. Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease. N Engl J Med. 2021 Jan 14;384(2):129-139. doi: 10.1056/NEJMoa2030186. Epub 2020 Nov 16.
Reference Type
BACKGROUND
Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.
Reference Type
BACKGROUND
Markham A, Keam SJ. Sotagliflozin: First Global Approval. Drugs. 2019 Jun;79(9):1023-1029. doi: 10.1007/s40265-019-01146-5.
Reference Type
BACKGROUND
Nardone M, Kugathasan L, Sridhar VS, Dutta P, Campbell DJT, Layton AT, Perkins BA, Barbour S, Lam TKT, Levin A, Lovblom LE, Mucsi I, Rabasa-Lhoret R, Rac VE, Senior P, Sigal RJ, Stanimirovic A, Persson F, Stougaard EB, Doria A, Cherney DZI. Modeling Cardiorenal Protection with Sodium-Glucose Cotransporter 2 Inhibition in Type 1 Diabetes: An Analysis of DEPICT-1 and DEPICT-2. Clin J Am Soc Nephrol. 2025 Apr 1;20(4):529-538. doi: 10.2215/CJN.0000000641. Epub 2025 Feb 7.
Reference Type
DERIVED
Other Identifiers
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STUDY00000249
Identifier Type: -
Identifier Source: org_study_id
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