Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study
- Status
- Enrolling by invitationResults none
- Why it is watched
- non-weight indication: cardiovascular, kidney
- Who it enrolls
- age 18 Years to no upper limit; no BMI minimum stated; conditions: Type 2 DM; Type 2 DM /Diabetic Nephropathy; Albuminuria
- Interventions
- Semaglutide, 1.34 mg/mL; Finerenone Oral Tablet; Dapagliflozin (DAPA)
- Conditions
- Type 2 DM; Type 2 DM /Diabetic Nephropathy; Albuminuria
- Phase and size
- Phase 4 · 50 participants
- Dates
- Start 2025-11-20
Primary completion 2026-11-30 - Sponsor
- Steno Diabetes Center Copenhagen (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Proteomic feasibility2 weeks from sampling
- Evaluation of medical treatment3 weeks from sampling
02Eligibility
Who can take part
Inclusion Criteria: 1. Men and women over 18 years of age. 2. Type 2 diabetes with no clinical signs of HF NYHA Class IV 3. Able to understand the written participant information and give informed consent. Exclusion Criteria: 1. Heart failure NYHA class IV at screening 2. 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. 3. 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. 4. Receiving therapy with all three of the study medication prior to enrolment. 5. Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment 6. Known or suspected hypersensitivity to the study medications or related products 7. History of pancreatitis at the screening visit 8. Body mass index \< 18.5 kg/m2 at the screening visit 9. Type 1 diabetes 10. Serum potassium \> 5.0 mmol/L at the screening visit 11. Addison's Disease 12. Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone) 13. Treatment with a potassium-sparing diuretic (amiloride, triamterene) 14. Treatment with other mineralocorticoid receptor antagonist than finerenone (e.g., spironolactone, eplerenone, esaxerenone, canrenone) 15. 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.) 16. Autosomal dominant or autosomal recessive polycystic kidney disease 17. Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening 18. Kidney transplant or dialysis 19. Presence or history of malignant neoplasms (except basal cell skin cancer or squamous cell skin cancer) within five years before screening. 20. Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements. 21. Known or suspected abuse of narcotics. 22. Participant in another intervention study, 23. Vulnerable (i.e., under guardianship) or mentally incapacitated subjects (i.e., not able to understand and sign the informed consent)
03Change log
Registry changes
No changes recorded since the trial was added.