Trial · NCT06217302
Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
NCT06217302, Phase 3, Recruiting, Alessandro Doria
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease. Trials, record NCT06217302. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06217302
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
- NCT number
- NCT06217302
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 150 participants, estimated
- Lead sponsor
- Alessandro Doria
- Conditions
- Diabetic Nephropathies, Kidney Failure, Chronic, Diabetes Mellitus Type 1, Heart Failure
- Interventions
- Sotagliflozin, Placebo
- First posted
- 2024-01-22
- Last updated
- 2026-03-24
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | eGFR at the end of the wash-out period following the treatment period | End of the 2-month wash-out period following the 3-year treatment period (weeks 162 and 164) | eGFR at the end of the 8-week drug washout period following the 3-year treatment period, estimated from Central Lab serum creatinine and cystatin C using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation and adjusted by its baseline value. Baseline and end-of-washout eGFRs will be considered as the average of two eGFR values taken on two separate days before randomization (V2 and V4) and after the washout (V18 and V19), respectively. |
| Secondary | Time to ≥40% eGFR decline from baseline, kidney failure , or death from renal causes | Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164) | Time from randomization to 1. sustained ≥40% eGFR decline (based on eGFR estimated from serum creatinine and cystatin C using the 2021 CKD-EPI equation) confirmed after 30 days; 2. kidney failure, defined by eGFR ≤10ml/min/ 1.73m2 confirmed after 30 days or occurring within 30 days prior to death, or initiation of maintenance kidney replacement therapy; or 3. death from kidney-related causes. If an eGFR value meeting the above criteria is observed at the last study visit or immediately before a participant is lost to follow-up or withdraws from the study, no confirmation of this value will be necessary. |
| Other | eGFR at the end of the 3-yr treatment period | End of the 3-year treatment period (week 156) | eGFR at the end of the 3-yr treatment period (before the washout period) adjusted for the baseline value |
| Other | Time to fatal or non-fatal cardiovascular disease (CVD) events | Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164) | Time to fatal or non-fatal CVD events (CV death, non-fatal myocardial infarction, non-fatal stroke, or coronary, carotid, or peripheral revascularization procedures) |
| Other | Time to hospitalization or urgent visit for heart failure or CV death | Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164) | Time to hospitalization or urgent visit for heart failure or death for cardiovascular causes |
| Other | Time to hospitalization for heart failure | Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164) | Time to hospitalization for heart failure |
| Other | B-type natriuretic peptide (NTproBNP) serum levels at the end of the drug washout | End of the 2-month wash-out period following the 3-year treatment period (week 164) | Serum levels of NTproBNP at the end of the 8-week drug washout, adjusted for its baseline value |
| Other | High-sensitivity cardiac troponin (hs-cTnT) serum levels at the end of the drug washout | End of the 2-month wash-out period following the 3-year treatment period (week 164) | Serum levels of hs-cTnT at the end of the 8-week drug washout, adjusted for its baseline value |
| Other | NTproBNP serum levels at the end of the treatment period | End of the 3-year treatment period (week 156) | Serum levels of B-type natriuretic peptide (NTproBNP) at the end of the 3-year treatment period, adjusted for its baseline value |
| Other | hs-cTnT serum levels at the end of the treatment period | End of the 3-year treatment period (week 156) | Serum levels of high-sensitivity cardiac troponin (hs-cTnT ) at the end of the 3-year treatment period, adjusted for its baseline value |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06217302
GET https://conductscience.org/api/trials/v1/NCT06217302/registered?page=2