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

Launched by STENO DIABETES CENTER COPENHAGEN · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new method to help manage Type 2 diabetes and prevent serious complications like kidney and heart issues. Researchers want to see if testing urine for specific protein patterns can help identify patients at risk for these complications. By doing this, they hope to determine which patients would benefit from additional protective treatments.

To participate in the study, you need to be at least 18 years old and have Type 2 diabetes without severe heart failure symptoms. However, there are several conditions that would exclude someone from joining, such as severe kidney problems or recent heart issues. If eligible, participants will undergo tests and possibly receive new treatment options aimed at reducing the risk of complications. It’s important to note that the trial is not yet recruiting participants, so there will be more information available once it begins.

Gender

ALL

Eligibility criteria

• 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)