Actively Recruiting
Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
Led by Alessandro Doria · Updated on 2026-03-24
150
Participants Needed
19
Research Sites
234 weeks
Total Duration
On this page
Sponsors
A
Alessandro Doria
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial 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. 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
Official Title
Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type 1 diabetes continuously treated with insulin for at least 8 years
- Estimated glomerular filtration rate (eGFR) between 20 and 60 ml/min/1.73 m2 at screening
- Urinary albumin creatinine ratio (UACR) of 200 mg/g or higher at screening, or UACR of 100 mg/g or higher with previous elevated UACR while on renin-angiotensin system blockers
- HbA1c below 10% at screening
- Receiving standard care including renin-angiotensin system blockers unless contraindicated or not tolerated
- Blood pressure consistently 155/95 mmHg or lower at screening or during run-in period
- Willing and able to follow study schedule, provide consent, and wear continuous glucose monitoring device for the study duration
You will not qualify if you...
- Type 2 diabetes, monogenic diabetes, or diabetes secondary to pancreatic disease
- Use of unapproved automated insulin delivery devices or improper use of such devices
- Use of any SGLT inhibitor in the 2 months before screening
- Use of dual medication renin-angiotensin system blockers (except allowed combinations with spironolactone, eplerenone, finerenone)
- Use of GLP-1 receptor agonists or other non-insulin glucose-lowering drugs not stable for more than 2 months
- Use of anti-TNF alpha biologic medications at screening
- Allergies or intolerance to sotagliflozin
- History of three or more severe hypoglycemic events in past 3 months
- History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar state recently or multiple episodes in last year
- Elevated blood beta-hydroxybutyrate levels during run-in or inadequate ketone testing
- History of primary renal glycosuria or biopsy-proven non-diabetic chronic kidney disease
- History of kidney transplant or chronic dialysis
- History or current decompensated cirrhosis or significant liver disease
- Severe immunocompromised status or HIV infection
- Recent cancer treatment (with certain exceptions)
- Recent illicit drug abuse or heavy alcohol use
- Participation in another interventional clinical trial within 30 days
- Breastfeeding, pregnancy, or unwillingness to use contraception
- Any medical condition or findings that interfere with study conduct or compliance
- Any condition preventing study completion or protocol adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Stanford University Medical Center
Stanford, California, United States, 94305
Actively Recruiting
2
Barbara Davis Center / University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
3
AdventHealth
Orlando, Florida, United States, 32803
Actively Recruiting
4
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
7
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
8
Albert Einstein College of Medicine / Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
9
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
10
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
11
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
12
University of Washington
Seattle, Washington, United States, 98105
Actively Recruiting
13
Providence Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Actively Recruiting
14
Unversity of Calgary
Calgary, Alberta, Canada, T2T 5C7
Actively Recruiting
15
Alberta Diabetes Institute
Edmonton, Alberta, Canada, T6G 2E1
Actively Recruiting
16
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
17
LMC Diabetes and Endocrinology
Toronto, Ontario, Canada, M4G 3E8
Actively Recruiting
18
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
19
Institut de Recherches Cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7
Actively Recruiting
Research Team
C
Christine Mendonca
CONTACT
A
Alexis Puthussery
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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