RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether sotagliflozin can slow kidney damage in people with type 1 diabetes and moderate to advanced kidney disease caused by diabetes. People will take the study drug or a look-alike pill with no active drug for 3 years. The study includes close monitoring and training to help prevent a dangerous buildup of acids called ketones in the blood.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had type 1 diabetes for at least 8 years and started ongoing insulin treatment within 1 year of diagnosis.
  • Have an eGFR of 20–60, a blood test score showing how well your kidneys filter waste. Some people may repeat the test.
  • Have enough protein in your urine: a urine albumin-to-creatinine ratio of at least 200 mg/g, or at least 100 mg/g with a past result of at least 30 while on a stable dose of kidney-protecting medicine.
  • Have an A1c below 10%. This test measures average blood sugar. Some people may repeat the test.
  • Receive usual diabetes and kidney care, including a RAS blocker, a kidney-protecting medicine, unless you cannot safely take it.
  • Have blood pressure at or below 155/95 at screening, after the study's preparation period, or on consistent home readings during that period.
  • Be willing to wear a continuous glucose monitor, a device that tracks blood sugar, throughout the study.
  • Be able to follow the study schedule and rules and give written consent.

Who can't join

  • Have another type of diabetes, or use an insulin delivery device that is not approved or is used against the maker's instructions.
  • Have used an SGLT drug in the past 2 months; take certain restricted medicines; or have an allergy or cannot tolerate sotagliflozin. Other non-insulin diabetes medicines must have been at a stable dose for more than 2 months.
  • Have had 3 or more low-blood-sugar events needing another person's help in the past 3 months, or recent or repeated dangerous high-blood-sugar crises, including ketoacidosis.
  • Have repeated high blood ketone levels during the preparation period, or complete fewer than half of the required ketone tests.
  • Have certain other kidney diseases, a kidney transplant, or ongoing dialysis; liver scarring or certain abnormal liver tests; HIV or a severely weakened immune system.
  • Have had cancer treatment in the past year, with some exceptions; illegal drug abuse in the past 6 months; or heavy alcohol use as defined by the study.
  • Are pregnant, breastfeeding, or unwilling to use birth control during the study, or have joined another treatment research study in the past 30 days.
  • Have another health issue or condition that could affect the study results or keep you from following or finishing the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (13)

CA

CO

FL

IL

MA

MO

  • Washington University · St Louis, MO 63110Heather Schaefer · Study contact · hschaefer@wustl.eduJanet McGill, MD · Principal investigatorKai Jones, MD · Sub-investigatorMaamoun Salam, MD · Sub-investigatorMore trials in St Louis

NY

OH

OR

TX

WA

  • University of Washington · Seattle, WA 98105Anjali Kumari · Study contact · anjalikr@uw.eduBri Hihara · Study contact · bhihara@uw.eduPetter Bjornstad, MD · Principal investigatorIrl Hirsch, MD · Sub-investigatorMore trials in Seattle
  • Providence Sacred Heart Medical Center · Spokane, WA 99204Nicole Maser · Study contact · Nicole.maser@providence.orgKatherine R. Tuttle, MD · Principal investigatorRadica Alicic, MD · Sub-investigatorMichael Ryan, MD · Sub-investigatorMore trials in Spokane