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

What this study is testing ClinicalTrials.gov NCT06954090 ↗

Description as written by the study sponsor.

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.

Treatments tested

• Semaglutide, 1.34 mg/mL also known as Ozempic Drug

  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.

• Finerenone Oral Tablet Drug

  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).

• Dapagliflozin (DAPA) Drug

  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.