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NCT06217302 · ClinicalTrials.gov registry record · Phase 3
Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
A Phase 3 study of Heart Failure and Diabetes Mellitus, Type 1, sponsored by Alessandro Doria.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
- 18
- Study locations
NCT06217302 is a Phase 3 study of Heart Failure and Diabetes Mellitus, Type 1 that is actively recruiting participants, run by Alessandro Doria. The registered enrollment target is 150 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (93% lower). The trial reports 18 study locations across 14 states.
The verdict
NCT06217302, a Phase 3 study of Heart Failure and Diabetes Mellitus, Type 1, is actively recruiting participants, sponsored by Alessandro Doria.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
- 18
- Study locations
Study Summary
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Study Locations (18)
New York
- SUNY Upstate Medical University - Syracuse
- Albert Einstein College of Medicine / Montefiore Medical Center - The Bronx
Washington
- University of Washington - Seattle
- Providence Sacred Heart Medical Center - Spokane
Alberta
- Unversity of Calgary - Calgary
- Alberta Diabetes Institute - Edmonton
Ontario
- LMC Diabetes and Endocrinology - Toronto
- Toronto General Hospital - Toronto
California
- Stanford University Medical Center - Stanford
Colorado
- Barbara Davis Center / University of Colorado Denver - Aurora
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Massachusetts
- Joslin Diabetes Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-10-31 |
| Est. Completion | 2029-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06217302
The ClinicalTrials.gov registry entry for NCT06217302 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (93% lower). The listed sponsor is Alessandro Doria, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06217302 reports 18 study locations spanning 14 distinct geographic areas - top geographies include New York, Washington, Alberta.
Frequently Asked Questions
What is clinical trial NCT06217302 about?
NCT06217302 is a clinical study titled "Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease". 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 o...
What is the current status of trial NCT06217302?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2024-10-31. Estimated completion is 2029-05.
What conditions does trial NCT06217302 study?
This clinical trial studies the following conditions: Heart Failure, Diabetes Mellitus, Type 1, Kidney Failure, Chronic, Diabetic Nephropathies.
What interventions are being tested in trial NCT06217302?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT06217302?
This trial is sponsored by Alessandro Doria, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06217302 being conducted?
This trial has 18 study locations across California, Colorado, Illinois, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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