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

What Was Tested

The trial (phase 4) is built around Semaglutide.

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.

It had three arms (groups): Semaglutide (active comparator), Finerenone (active comparator) and Dapagliflozin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Currently, there is no reliable method for predicting personalized treatment responses in diabetic complications.

CKD273 urine proteomic risk score is a well-established tool used to predict the risk of chronic kidney disease (CKD) progression.

CAD160 is urine proteomic risk score to predict the risk of coronary artery disease (CAD).

HF2 urine proteomic classifier is used to predict the risk of heart failure (HF).

Who Took Part

Enrollment: 50 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men and women over 18 years of age. Able to understand the written participant information and give informed consent.

The full record lists 3 inclusion and 23 exclusion criteria; among the exclusions: heart failure nyha class iv at screening; receiving therapy with all three of the study medication prior to enrolment; myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-11-20 with completion listed for 2026-11-30.

It ran at 1 site in Denmark.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Proteomic feasibility (time frame: 2 weeks from sampling). Evaluation of medical treatment (time frame: 3 weeks from sampling).

It also tracked 2 secondary outcomes, for example Urine Albumin-to-Creatinine Ratio and Urinary proteomic signatures.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Semaglutide in 50 people.

Its status is enrolling by invitation; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.