← Trials/Trial dossier/NCT06954090
SIGNAL
Enrolling by invitationPhase 4Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study
SIGNAL - Body Fluid Proteome SIGnatures for persoNALised Intervention to Prevent Cardiovascular and Renal Complications in Diabetes
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
50
estimated
Study population
Type 2 diabetes
Key I/E criterion
—
Primary endpoints
•Proteomic feasibility•Evaluation of medical treatment
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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)
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Renal / kidney
2 endpointsUrine Albumin-to-Creatinine Ratio
Time frame:Over the 6 month of the follow up from screening visit to the end of study.
uACR, change
change from baseline, improvement
LOINC 9318-7
Urinary proteomic signatures
Time frame:Over the 6 month of the follow up from screening visit to the end of study.
change from baseline, improvement
Other (unclassified)
3 endpointsProteomic feasibility
Time frame:2 weeks from sampling
threshold achievement, descriptive
Evaluation of medical treatment
Time frame:3 weeks from sampling
threshold achievement, descriptive
Assessment of health economics
Time frame:6 months from all participent data is collected
descriptive
Publications (10)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Diabetes, obesity & metabolism2025 Aug (month)PMID40437949doi:10.1111/dom.16489via pubmed acronym asset candidate
- The Laryngoscope2025 Jul (month)PMID39936458doi:10.1002/lary.32061via pubmed acronym asset candidate
- Trends in pharmacological sciences2025 May (month)PMID40221226doi:10.1016/j.tips.2025.03.003via pubmed acronym asset candidate
- Science translational medicine2024 Dec 18PMID39693407doi:10.1126/scitranslmed.adp5765via pubmed acronym asset candidate
- JAMA network open2024 Aug 1PMID39163046doi:10.1001/jamanetworkopen.2024.23385via pubmed acronym asset candidate
- The Journal of endocrinology2024 Jul 1PMID38642585doi:10.1530/JOE-23-0405via pubmed acronym asset candidate
- Thyroid : official journal of the American Thyroid Association2024 Apr (month)PMID38343381doi:10.1089/thy.2023.0530via pubmed acronym asset candidate
- Molecular metabolism2024 Feb (month)PMID38218536doi:10.1016/j.molmet.2024.101880via pubmed acronym asset candidate
- Obesity (Silver Spring, Md.)2022 Apr (month)PMID35333444doi:10.1002/oby.23374via pubmed acronym asset candidate
- Frontiers in public health2022 (year)PMID36339230doi:10.3389/fpubh.2022.996179via pubmed acronym asset candidate
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.