RECRUITING

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

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Conditions

Diabetic NephropathiesKidney Failure, ChronicDiabetes Mellitus Type 1Heart FailureType 1 diabetesCardiovascular diseaseGlomerular filtration rateSGLT2 inhibitorsDiabetic kidney disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-31
Study Completion:2029-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06217302

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Type1 diabetes (T1D) continuously treated with insulin within one year from diagnosis.
  2. * Duration of T1D ≥ 8 years;
  3. * eGFR based on serum creatinine and cystatin C between 20 and 60 ml/min/1.73 m2 at screening;
  4. * First morning void urinary albumin/creatinine ratio (UACR) ≥200 mg/g at screening;
  5. * HbA1c \<10% at screening;
  6. * Receiving standard of care, including renin angiotensin system blockers (RASB) at a clinically appropriate dose, unless contraindicated or not tolerated.
  7. * 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.
  1. * Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease;
  2. * Use of non-FDA approved automated insulin delivery devices;
  3. * Use of any SGLT inhibitor in the previous 2 months;
  4. * Use of dual medication RASB therapy (spironolactone, eplerenone, finerenone are allowed in combination with RASB therapy);
  5. * Use of glucagon-like peptide (GLP-1) receptor agonists and other non-insulin glucose lowering agents if in use for less than 3 months and/or not on stable dose at screening;
  6. * Use of anti tumor necrosis factor (TNF) alpha biologic medications at screening;
  7. * Known allergies, hypersensitivity, or intolerance to SOTA;
  8. * History of ≥3 severe hypoglycemic events (requiring third-party assistance for correction) within 3 months of screening;
  9. * 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;
  10. * Blood beta-hydroxybutyrate (BHB) \>0.6 mmol/L for \>2 hours on \>2 occasions during the Run-in period;
  11. * Inadequate beta hydroxybutyrate (BHB) testing (\<50% of the prescribed measurements) during Run-in;
  12. * History of primary renal glycosuria;
  13. * History of biopsy-proven non-diabetic chronic kidney disease (CKD);
  14. * History of kidney transplant or currently on chronic dialysis;
  15. * 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).
  16. * History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status;
  17. * 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.
  18. * Illicit drug abuse within 6 months of screening;
  19. * 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);
  20. * Participation in another interventional clinical research study within 30 days of screening;
  21. * Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial;
  22. * Systolic blood pressure \>155 mmHg or diastolic blood pressure \>95 mmHg at screening;
  23. * 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;
  24. * Any condition that may render the patient unable to comply with study requirements and/or complete the study.

Contacts and Locations

Study Contact

Christine Mendonca
CONTACT
617-309-2735
christine.mendonca@joslin.harvard.edu
Emily Collins
CONTACT
emily.collins@joslin.harvard.edu

Principal Investigator

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

Study Locations (Sites)

Stanford University Medical Center
Stanford, California, 94305
United States
Barbara Davis Center / University of Colorado Denver
Aurora, Colorado, 80045
United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
United States
Joslin Diabetes Center
Boston, Massachusetts, 02215
United States
Washington University
St. Louis, Missouri, 63110
United States
Albert Einstein College of Medicine / Montefiore Medical Center
Bronx, New York, 10461
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
University of Texas Southwestern
Dallas, Texas, 75390
United States
University of Washington
Seattle, Washington, 98105
United States
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
United States

Collaborators and Investigators

Sponsor: Alessandro Doria

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-31
Study Completion Date2029-05

Study Record Updates

Study Start Date2024-10-31
Study Completion Date2029-05

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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