Skip to content
type1.science
Phase 2Not yet recruitingNCT07594145

Precision T1D Platform: finerenone or sotagliflozin for cardio-renal risk

What this study tests

Not-yet-recruiting US Phase 2 platform matching adults with long-standing T1D and early kidney or heart-risk markers to finerenone or sotagliflozin. It is a T1D complication study, not a Type 2 trial, and neither drug is approved here as a T1D cardio-renal treatment.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-08-10.

Most recent recorded citation date: 2026-08-10. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Adults 18–75 with T1D for more than 10 years, HbA1c 7–10%, and either early diabetic kidney disease (UACR above 30 mg/g with eGFR at least 60, on RAS blockade unless not tolerated) or early heart-failure risk (NT-proBNP at least 125 pg/mL). Type 2 diabetes, monogenic diabetes, and pancreatic diabetes are excluded. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
No results. Not yet recruiting; estimated n=57; estimated start 1 November 2026; estimated primary completion 31 December 2029. Last registry update 10 August 2026. Sites listed in Portland and Ann Arbor. Type 2 diabetes is an exclusion; this record is not scored on Type 2 evidence.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Percent change in UACR from baseline to week 26
  • Percent change in NT-proBNP from baseline to week 26
  • Incidence of treatment-emergent adverse events over 26 weeks

The full picture

This platform asks whether people with T1D and early kidney or heart-risk markers can be matched to an existing drug by endophenotype. Finerenone’s T1D kidney evidence remains FINE-ONE; sotagliflozin here is the US heart-failure brand Inpefa, not a Type 1 licence. A registered protocol is not a result, and Priority Review of finerenone is not an approval.

Sources

  1. [1]