Type 2 DMPhase 4SIGNALNCT06954090
Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study
A Phase 4 study testing Semaglutide, 1.34 mg/mL, Finerenone Oral Tablet and Dapagliflozin (DAPA) in people with Type 2 DM and Type 2 DM /Diabetic Nephropathy, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 DM, Type 2 DM /Diabetic Nephropathy, Albuminuria
- What is being tested?
- Semaglutide, 1.34 mg/mL, Finerenone Oral Tablet and Dapagliflozin (DAPA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Nov 2025to 31 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SIGNAL - Body Fluid Proteome SIGnatures for persoNALised Intervention to Prevent Cardiovascular and Renal Complications in Diabetes
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.
Read the 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 cardiovascular disease (CVD) and chronic kidney disease (CKD) remains a pressing concern, underscoring the need for optimized prevention strategies and improved therapeutic options. Recent developments in glucose-lowering drugs, such as sodium-glucosecotransporter- 2-inhibitors (SGLT2-i) and glucagon-like-peptide-1 receptor agonists (GLP1-RA), as well as the use of the non-steroidal mineralocorticoid receptor antagonist (nsMRA) finerenone, have shown promising cardiovascular and renal protection. Currently, there is no reliable method for predicting personalized treatment responses in diabetic complications. Consequently, benefits of treatment are under dispute, due to a large number of patients not responding. The use of SGLT2-i, nsMRA and GLP1-RA in CKD has happened largely in parallel, all agents have demonstrated benefit, but it is not yet clear how to prioritize between the drugs or if all should be combined. This study builds upon previous scientific work that have investigated the urine proteome and identified several biomarkers able to predict early diabetes associated complications.
CKD273 urine proteomic risk score is a well-established tool used to predict the risk of chronic kidney disease (CKD) progression. CAD160 is urine proteomic risk score to predict the risk of coronary artery disease (CAD). HF2 urine proteomic classifier is used to predict the risk of heart failure (HF).
Urine sample analysis is based on capillary electrophoresis coupled with mass spectrometry (CE-MS) to determine these risk scores.
Urine proteomic scores are continous numerical values. Higher score means that the urinary peptide pattern is more similar to that of patients with progressive disease. A lower score indicates a peptide profile more typical of healthy individuals.
In addition a Support Vector Machine (SVM), a supervised machine learning algorithm will perform in silico treatment simulations and calculate the change in classification scores for 3 different potential interventions: GLP1-RA semaglutide, SGT2-i dapagliflozin and GLP1-RA finerenone. Based on these changes (with the largest beneficial change indicating the most effective treatment), the most suitable intervention can be selected and the participent will be allocated.
Design:
Single-centre, open-label, parallel group (intervention group) with 6 months intervention.
Population:
Type 2 diabetes without history of heart failure NYHA Class IV or advanced diabetic kidney disease with an estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2 or urinary albumin creatinine ratio (UACR) > 200 mg/g.
Objectives:
To assess the feasibility of using proteomic classifiers in clinical practice for response prediction in a prospective study. We will use urinary proteomic classifiers: CKD273, CAD160 and HF2 to identify patients suited for additional medical treatment with sodium-glucose-cotransporter-2 (SGLT2)- inhibitors, glucagon-like-peptide-1 GLP-1 receptor agonists or non-steroidal mineralocorticoid receptor antagonist.
Interventions:
The SGLT2 inhibitor dapagliflozin 10 mg daily, the nsMRA finerenone 10-20 mg daily, and the GLP-1 receptor agonist semaglutide 0.25-1.0 mg once weekly. The medication will be given stepwise according to a prespecified algorithm and guided by the response on UACR.
Endpoints:
Primary endpoint is feasibility of using urinary proteomic classifiers in clinical practice, while secondary endpoints are changes in UACR and urinary proteomic signatures after 6 months of treatment.
Time schedule:
The study is expected to start inclusion June 1st 2025. The recruitment period is 6 months, the intervention period is 6 months and hence the study is expected to be terminated May 31st 2026.
- Conditions
- Type 2 DM, Type 2 DM /Diabetic Nephropathy, Albuminuria
- Being tested
- Semaglutide, 1.34 mg/mL, Finerenone Oral Tablet, Dapagliflozin (DAPA)
- Keywords
- urine proteomics, precision medicine, prevention of diabetic complications, personalized treatment, biomarker, CKD273
- Medical subject headings
- Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide, 1.34 mg/mLDrug
Also called Ozempic
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 TabletDrug
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)Drug
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 group | Role | What they receive |
|---|---|---|
| Semaglutide | Active comparator | 3 urine proteomic risk scores will be measured in the study. The CKD273 urine proteomic risk score, a well-established tool used to predict the risk of chronic kidney disease (CKD) progression, CAD160 urine proteomic risk score to predict the risk of coronary artery disease (CAD) and HF2 urine proteomic classifier to predict the risk of heart failure (HF).
In addition a Support Vector Machine (SVM), a supervised machine learning algorithm will perform in silico treatment simulations and calculate the change in classification scores for 3 different potential interventions: GLP1-RA semaglutide, SGT2-i dapagliflozin and GLP1-RA finerenone. Based on these changes (with the largest beneficial change indicating the most effective treatment), the most suitable intervention can be selected and the participent will be allocated. Receives: Drug: Semaglutide, 1.34 mg/mL |
| Finerenone | Active comparator | 3 urine proteomic risk scores will be measured in the study. The CKD273 urine proteomic risk score, a well-established tool used to predict the risk of chronic kidney disease (CKD) progression, CAD160 urine proteomic risk score to predict the risk of coronary artery disease (CAD) and HF2 urine proteomic classifier to predict the risk of heart failure (HF). In addition a Support Vector Machine (SVM), a supervised machine learning algorithm will perform in silico treatment simulations and calculate the change in classification scores for 3 different potential interventions: GLP1-RA semaglutide, SGT2-i dapagliflozin and GLP1-RA finerenone. Based on these changes (with the largest beneficial change indicating the most effective treatment), the most suitable intervention can be selected and the participent will be allocated. Receives: Drug: Finerenone Oral Tablet |
| Dapagliflozin | Active comparator | 3 urine proteomic risk scores will be measured in the study. The CKD273 urine proteomic risk score, a well-established tool used to predict the risk of chronic kidney disease (CKD) progression, CAD160 urine proteomic risk score to predict the risk of coronary artery disease (CAD) and HF2 urine proteomic classifier to predict the risk of heart failure (HF). In addition a Support Vector Machine (SVM), a supervised machine learning algorithm will perform in silico treatment simulations and calculate the change in classification scores for 3 different potential interventions: GLP1-RA semaglutide, SGT2-i dapagliflozin and GLP1-RA finerenone. Based on these changes (with the largest beneficial change indicating the most effective treatment), the most suitable intervention can be selected and the participent will be allocated. Receives: Drug: Dapagliflozin (DAPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomic feasibility
Achieve urine proteomic results within 2 weeks of sampling for at least 90% of the participants in clinical practice.
Measured: 2 weeks from sampling
Evaluation of medical treatment
Ensure that urine proteomic results are interpreted for evaluating medical treatment in at least 90% of participants.
Measured: 3 weeks from sampling
Secondary outcomes (2)
Urine Albumin-to-Creatinine Ratio
Changes in UACR from screening visit to the end of study
Measured: Over the 6 month of the follow up from screening visit to the end of study.
Urinary proteomic signatures
Changes in urinary proteomic signatures from screening visit to the end of study:
Urine proteomic risk scores are continous numerical values. Higher score means urinary peptide pattern is more similar to that of patients with progressive disease. A lower score indicates a peptide profile more typical of healthy individuals.
CKD273, CAD160 and HF2 urine proteomic risk-scores and their changes will be measured from urine samples during the study.
Measured: Over the 6 month of the follow up from screening visit to the end of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start20 Nov 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Low intervention feasibility study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Mosaiques Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Peter Rossing, Clinical Professor, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954090
- Sponsor's protocol ID
- 2024-518682-95
- Other IDs
- 2024-518682-95-00
- Acronym
- SIGNAL
- Status last verified
- Nov 2025
- First submitted
- 14 Apr 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIGNAL - Body Fluid Proteome SIGnatures for persoNALised Intervention to Prevent Cardiovascular and Renal Complications in Diabetes
- ClinicalTrials.gov ID
- NCT06954090
- Acronym / sponsor ID
- SIGNAL / 2024-518682-95
- Conditions
- Type 2 DM, Type 2 DM /Diabetic Nephropathy, Albuminuria
- Keywords
- urine proteomics, precision medicine, prevention of diabetic complications, personalized treatment, biomarker, CKD273
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Mosaiques Diagnostics GmbH
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 cardiovascular disease (CVD) and chronic kidney disease (CKD) remains a pressing concern, underscoring the need for optimized prevention strategies and improved therapeutic options. Recent developments in glucose-lowering drugs, such as sodium-glucosecotransporter- 2-inhibitors (SGLT2-i) and glucagon-like-peptide-1 receptor agonists (GLP1-RA), as well as the use of the non-steroidal mineralocorticoid receptor antagonist (nsMRA) finerenone, have shown promising cardiovascular and renal protection. Currently, there is no reliable method for predicting personalized treatment responses in diabetic complications. Consequently, benefits of treatment are under dispute, due to a large number of patients not responding. The use of SGLT2-i, nsMRA and GLP1-RA in CKD has happened largely in parallel, all agents have demonstrated benefit, but it is not yet clear how to prioritize between the drugs or if all should be combined. This study builds upon previous scientific work that have investigated the urine proteome and identified several biomarkers able to predict early diabetes associated complications.
CKD273 urine proteomic risk score is a well-established tool used to predict the risk of chronic kidney disease (CKD) progression. CAD160 is urine proteomic risk score to predict the risk of coronary artery disease (CAD). HF2 urine proteomic classifier is used to predict the risk of heart failure (HF).
Urine sample analysis is based on capillary electrophoresis coupled with mass spectrometry (CE-MS) to determine these risk scores.
Urine proteomic scores are continous numerical values. Higher score means that the urinary peptide pattern is more similar to that of patients with progressive disease. A lower score indicates a peptide profile more typical of healthy individuals.
In addition a Support Vector Machine (SVM), a supervised machine learning algorithm will perform in silico treatment simulations and calculate the change in classification scores for 3 different potential interventions: GLP1-RA semaglutide, SGT2-i dapagliflozin and GLP1-RA finerenone. Based on these changes (with the largest beneficial change indicating the most effective treatment), the most suitable intervention can be selected and the participent will be allocated.
Design:
Single-centre, open-label, parallel group (intervention group) with 6 months intervention.
Population:
Type 2 diabetes without history of heart failure NYHA Class IV or advanced diabetic kidney disease with an estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2 or urinary albumin creatinine ratio (UACR) > 200 mg/g.
Objectives:
To assess the feasibility of using proteomic classifiers in clinical practice for response prediction in a prospective study. We will use urinary proteomic classifiers: CKD273, CAD160 and HF2 to identify patients suited for additional medical treatment with sodium-glucose-cotransporter-2 (SGLT2)- inhibitors, glucagon-like-peptide-1 GLP-1 receptor agonists or non-steroidal mineralocorticoid receptor antagonist.
Interventions:
The SGLT2 inhibitor dapagliflozin 10 mg daily, the nsMRA finerenone 10-20 mg daily, and the GLP-1 receptor agonist semaglutide 0.25-1.0 mg once weekly. The medication will be given stepwise according to a prespecified algorithm and guided by the response on UACR.
Endpoints:
Primary endpoint is feasibility of using urinary proteomic classifiers in clinical practice, while secondary endpoints are changes in UACR and urinary proteomic signatures after 6 months of treatment.
Time schedule:
The study is expected to start inclusion June 1st 2025. The recruitment period is 6 months, the intervention period is 6 months and hence the study is expected to be terminated May 31st 2026.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Low intervention feasibility study
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Active comparator | Drug: Semaglutide, 1.34 mg/mL3 urine proteomic risk scores will be measured in the study. The CKD273 urine proteomic risk score, a well-established tool used to predict the risk of chronic kidney disease (CKD) progression, CAD160 urine proteomic risk score to predict the risk of coronary artery disease (CAD) and HF2 urine proteomic classifier to predict the risk of heart failure (HF). In addition a Support Vector Machine (SVM), a supervised machine learning algorithm will perform in silico treatment simulations and calculate the change in classification scores for 3 different potential interventions: GLP1-RA semaglutide, SGT2-i dapagliflozin and GLP1-RA finerenone. Based on these changes (with the largest beneficial change indicating the most effective treatment), the most suitable intervention can be selected and the participent will be allocated. |
| Finerenone | Active comparator | Drug: Finerenone Oral Tablet3 urine proteomic risk scores will be measured in the study. The CKD273 urine proteomic risk score, a well-established tool used to predict the risk of chronic kidney disease (CKD) progression, CAD160 urine proteomic risk score to predict the risk of coronary artery disease (CAD) and HF2 urine proteomic classifier to predict the risk of heart failure (HF). In addition a Support Vector Machine (SVM), a supervised machine learning algorithm will perform in silico treatment simulations and calculate the change in classification scores for 3 different potential interventions: GLP1-RA semaglutide, SGT2-i dapagliflozin and GLP1-RA finerenone. Based on these changes (with the largest beneficial change indicating the most effective treatment), the most suitable intervention can be selected and the participent will be allocated. |
| Dapagliflozin | Active comparator | Drug: Dapagliflozin (DAPA)3 urine proteomic risk scores will be measured in the study. The CKD273 urine proteomic risk score, a well-established tool used to predict the risk of chronic kidney disease (CKD) progression, CAD160 urine proteomic risk score to predict the risk of coronary artery disease (CAD) and HF2 urine proteomic classifier to predict the risk of heart failure (HF). In addition a Support Vector Machine (SVM), a supervised machine learning algorithm will perform in silico treatment simulations and calculate the change in classification scores for 3 different potential interventions: GLP1-RA semaglutide, SGT2-i dapagliflozin and GLP1-RA finerenone. Based on these changes (with the largest beneficial change indicating the most effective treatment), the most suitable intervention can be selected and the participent will be allocated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide, 1.34 mg/mLAlso: OzempicSemaglutide 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. | Drug | Semaglutide |
| Finerenone Oral TabletFinerenone 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). | Drug | Finerenone |
| 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. | Drug | Dapagliflozin |
Primary outcome
Proteomic feasibility
Time frame: 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
Time frame: 3 weeks from sampling
Ensure that urine proteomic results are interpreted for evaluating medical treatment in at least 90% of participants.
2 secondary outcomes
Urine Albumin-to-Creatinine Ratio
Time frame: Over the 6 month of the follow up from screening visit to the end of study.
Urinary proteomic signatures
Time frame: Over the 6 month of the follow up from screening visit to the end of study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Rossing, Clinical Professor principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide, 1.34 mg/mL, Finerenone Oral Tablet and Dapagliflozin (DAPA) in people with Type 2 DM and Type 2 DM /Diabetic Nephropathy, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomic feasibility (time frame: 2 weeks from sampling). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.