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ENROLLING BY INVITATION
NCT06954090
PHASE4

Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study

Sponsor: Steno Diabetes Center Copenhagen

View on ClinicalTrials.gov

Summary

Title: Body fluid proteome SIGnatures for persoNALised intervention to prevent cardiovascular and renal complications in diabetes. Aim: To explore the feasibility of using urinary proteomic risk scores in clinical practice to identify patients at risk of developing end organ damage and identify which patients should receive additional renocardiovascular protective treatment.

Official title: SIGNAL - Body Fluid Proteome SIGnatures for persoNALised Intervention to Prevent Cardiovascular and Renal Complications in Diabetes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-11-20

Completion Date

2027-05-31

Last Updated

2025-12-22

Healthy Volunteers

No

Interventions

DRUG

Semaglutide, 1.34 mg/mL

Semaglutide will be introduced at a dose of 0.25 mg/week subcutaneous injection, escalated to 0.5 and 1.0 mg/week after 4 and 8 weeks if tolerated.

DRUG

Finerenone Oral Tablet

Finerenone will be introduced at a dose of 10 mg/day in patients with a serum potassium level \< 4.8 mmol/l and eGFR \< 60 ml/min/1.73 m2 and escalated to 20 mg/day after 4 weeks if the serum potassium level is still \< 4.8 mmol/l. Starting dose is 20 mg/day if eGFR ≥ 60 ml/min/1.73 m2. The dosage will be reduced or discontinued in patients who develop hyperkalemia (serum potassium \> 5.5 mmol/l).

DRUG

Dapagliflozin (DAPA)

Dapagliflozin will be introduced at a dose of 10 mg/day. The dose can be reduced at any time during the trial if required by the subject's tolerance to the product.

Locations (1)

Steno Diabetes Center Copenhagen

Herlev, Hajdú-Bihar, Denmark