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

NCT06954090 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

  • Type 2 DM
  • Type 2 DM /Diabetic Nephropathy
  • Albuminuria

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.

Sponsors & Collaborators

  • Mosaiques Diagnostics GmbH

    collaborator UNKNOWN

  • Steno Diabetes Center Copenhagen

    lead OTHER

Principal Investigators

  • Peter Rossing, Clinical Professor · Steno Diabetes Center Copenhagen

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2026-11-30
Completion
2027-05-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06954090 on ClinicalTrials.gov