Condition: Diabetic Nephropathies · Kidney Failure, Chronic · Diabetes Mellitus Type 1 · Sponsor: Alessandro Doria
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 group…
This description comes directly from the study's public registry record.
Christine Mendonca · 617-334-2257 · christine.mendonca@joslin.harvard.edu
Alexis Puthussery · 617-975-8235 · aputhuss@joslin.harvard.edu
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| Stanford University Medical Center | Stanford, California, United States | Recruiting |
| Barbara Davis Center / University of Colorado Denver | Aurora, Colorado, United States | Recruiting |
| AdventHealth | Orlando, Florida, United States | Recruiting |
| Northwestern University Feinberg School of Medicine | Chicago, Illinois, United States | Recruiting |
| Joslin Diabetes Center | Boston, Massachusetts, United States | Recruiting |
| Washington University | St Louis, Missouri, United States | Recruiting |
| SUNY Upstate Medical University | Syracuse, New York, United States | Recruiting |
| Albert Einstein College of Medicine / Montefiore Medical Center | The Bronx, New York, United States | Recruiting |
| Cleveland Clinic Foundation | Cleveland, Ohio, United States | Recruiting |
| Oregon Health and Science University | Portland, Oregon, United States | Recruiting |
| University of Texas Southwestern | Dallas, Texas, United States | Recruiting |
| University of Washington | Seattle, Washington, United States | Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06217302