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Prevention of CKD progression in type 1 diabetes with Long term Use of SGLTi avoiding kidney hypOxia (PLUTO)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509450-55-01
Enrollment
39
Registered
2024-08-08
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus with chronic kidney complications

Brief summary

Change from 0 to 12 weeks in dynamic R2*-weighted signal (BOLD) as an indirect measure of renal blood oxygenation after treatment with sotagliflozin compared with placebo.

Interventions

DRUGSOTAGLIFLOZIN
DRUGPLACEBO PRODUCT [PLACEBO MATCHING SOTAGLIFLOZIN 200 MG FILM-COATED TABLETS]

Sponsors

Steno Diabetes Center Copenhagen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from 0 to 12 weeks in dynamic R2*-weighted signal (BOLD) as an indirect measure of renal blood oxygenation after treatment with sotagliflozin compared with placebo.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026