Urine Tests to Guide Treatment in Type 2 Diabetes
Tests urine protein patterns to guide extra kidney and heart protection in type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study
Key facts
- Where
- Herlev, DenmarkSee the site
- Phase
- Phase 4
Where in Denmark
- Steno Diabetes Center CopenhagenHerlev, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Steno Diabetes Center Copenhagen
- Trial code
- NCT06954090EU 2024-518682-95-00
- Record updated
- 22 December 2025
- Original description
Title:Read full original descriptionShow less
SIGNAL - Body Fluid Proteome SIGnatures for persoNALised Intervention to Prevent Cardiovascular and Renal Complications in Diabetes
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.
Inclusion: Men and women over 18 years of age; Type 2 diabetes with no clinical signs of HF NYHA Class IV; Able to understand the written participant information and give informed consent.
Exclusion: 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; Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone); Treatment with other mineralocorticoid receptor antagonist than finerenone (e.g., spironolactone, eplerenone, esaxerenone, canrenone); Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening; Kidney transplant or dialysis; Heart failure NYHA class IV at screening; Known or suspected hypersensitivity to the study medications or related products; History of pancreatitis at the screening visit; Type 1 diabetes; Addison's Disease; Autosomal dominant or autosomal recessive polycystic kidney disease; Presence or history of malignant neoplasms (except basal cell skin cancer or squamous cell skin cancer) within five years before screening; Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements; Moderately - or severely increased albuminuria with a UACR ≥ 200 mg/g or CKD with an eGFR < 30 ml/min/1.73m2 at the screening visit; Serum potassium > 5.0 mmol/L at the screening visit; Treatment with a potassium-sparing diuretic (amiloride, triamterene); Elevated Alanine Aminotransferase (ALT) > 3x upper normal limit, autoimmune hepatitis, and/or severe hepatic impairment (including but not limited to a history of hepatic encephalopathy, a history of oesophageal varices or a history of portocaval shunt.); A female who is pregnant, breastfeeding, or intends to become pregnant, or women of childbearing potential (WOCBP) who are not using highly effective contraceptive methods; Body mass index < 18.5 kg/m2 at the screening visit; Known or suspected abuse of narcotics; Participant in another intervention study,; Vulnerable (i.e., under guardianship) or mentally incapacitated subjects (i.e., not able to understand and sign the informed consent).