Semaglutide, 1.34 mg/mL: Semaglutide will be introduced at a dose of 0.25 mg/week subcutaneous injection, escalated to 0.5 and 1.0 mg/week after 4 and 8 weeks if tolerated.
Finerenone Oral Tablet: Finerenone will be introduced at a dose of 10 mg/day in patients with a serum potassium level \< 4.8 mmol/l and eGFR \< 60 ml/min/1.73 m2 and escalated to 20 mg/day after 4 weeks if the serum potassium level is still \< 4.8 mmol/l. Starting dose is 20 mg/day if eGFR ≥ 60 ml/min/1.73 m2. The dosage will be reduced or discontinued in patients who develop hyperkalemia (serum potassium \> 5.5 mmol/l).
Dapagliflozin (DAPA): Dapagliflozin will be introduced at a dose of 10 mg/day. The dose can be reduced at any time during the trial if required by the subject's tolerance to the product.
Study 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 scores in clinical practice to identify patients at risk of developing end organ damage and identify which patients should receive additional renocardiovascular protective treatment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Proteomic feasibility — 2 weeks from sampling Achieve urine proteomic results within 2 weeks of sampling for at least 90% of the participants in clinical practice.
Evaluation of medical treatment — 3 weeks from sampling Ensure that urine proteomic results are interpreted for evaluating medical treatment in at least 90% of participants.
Trial sites (1)
Facility
City
Region
Status
Steno Diabetes Center Copenhagen
Herlev
Hajdú-Bihar
More Steno Diabetes Center Copenhagen trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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