Status:
ENROLLING_BY_INVITATION
Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Mosaiques Diagnostics GmbH
Conditions:
Type 2 DM
Type 2 DM /Diabetic Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 sc...
Detailed Description
Background: Diabetes and its associated complications impose a significant burden on both patients and societies. Despite advancements in lowering blood glucose, the elevated risk of developing cardi...
Eligibility Criteria
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
- Heart failure NYHA class IV at screening
- 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.
- 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.
- 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
- Known or suspected hypersensitivity to the study medications or related products
- History of pancreatitis at the screening visit
- Body mass index \< 18.5 kg/m2 at the screening visit
- Type 1 diabetes
- Serum potassium \> 5.0 mmol/L at the screening visit
- Addison's Disease
- Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone)
- Treatment with a potassium-sparing diuretic (amiloride, triamterene)
- Treatment with other mineralocorticoid receptor antagonist than finerenone (e.g., spironolactone, eplerenone, esaxerenone, canrenone)
- 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.)
- Autosomal dominant or autosomal recessive polycystic kidney disease
- 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
- 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.
- 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)
Key Trial Info
Start Date :
November 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06954090
Start Date
November 20 2025
End Date
May 31 2027
Last Update
December 22 2025
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Herlev, Hajdú-Bihar, Denmark, 2730