Feasibility of Urinary Proteomic Signatures in Identifying Type 2 Diabetes Patients for Dapagliflozin, Semaglutide, and Finerenone Treatment
- Trial ID
- 2024-518682-95-00
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to explore the feasibility of utilizing **urinary proteomic** signatures in clinical practice to identify patients with **Type 2 Diabetes** who are at risk of developing end organ damage. This is clinically relevant as it aims to determine which patients would benefit from additional reno-cardiovascular protective treatments. The study will employ urinary proteomic classifiers, specifically CKD273, CAD160, and HF2, to identify patients who may be suitable for further medical intervention with sodium-glucose-cotransporter-2 inhibitors, glucagon-like-peptide-1 receptor agonists, or non-steroidal mineralocorticoid receptor antagonists. The study does not list any secondary objectives.
Participants
The clinical trial involves participants diagnosed with **Type 2 Diabetes** who do not exhibit clinical signs of heart failure, cardiovascular disease, or diabetic kidney disease. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their medical condition and absence of specific comorbidities. Lifestyle factors such as diet, physical activity, and habits are not specified in the available data. The trial aims to explore the feasibility of using urinary proteomic signatures to identify patients at risk of developing end organ damage and to determine which patients may benefit from additional reno-cardiovascular protective treatment.
Plans and Procedures
The clinical trial is designed to evaluate the feasibility of using urinary proteomic signatures to identify patients with **Type 2 Diabetes** who are at risk of developing end organ damage and may benefit from additional reno-cardiovascular protective treatment. This study employs a **randomized, double-blind, controlled** design to ensure the reliability and validity of the results. The trial is expected to commence on February 1, 2025, and conclude by January 31, 2026, with a total duration of approximately one year.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on the principal inclusion criteria, which require the presence of Type 2 diabetes without clinical signs of heart failure, cardiovascular disease, or diabetic kidney disease. Following the screening, participants will be randomly assigned to receive one of the investigational medicinal products: **dapagliflozin**, **semaglutide**, or **finerenone**. These medications will be administered according to their respective routes, either orally or via subcutaneous injection, for a maximum treatment period of six months.
Throughout the trial, participants will attend regular follow-up visits to monitor their health status and assess primary and secondary endpoints. The primary endpoint focuses on the feasibility of the intervention, while secondary endpoints include changes in urinary albumin excretion, urinary proteomic signatures, and estimated glomerular filtration rate (eGFR) levels. The end-of-study visit will occur at the conclusion of the treatment period, where final assessments will be conducted to evaluate the overall outcomes of the trial.
Participant involvement is expected to last for the entire duration of the treatment period, approximately six months, with additional time allocated for follow-up assessments. Conditions that may lead to early termination from the study include adverse reactions to the investigational products, withdrawal of consent, or any significant health changes that contraindicate continued participation. The trial is classified as low intervention, as all investigational products are authorized and used in accordance with their marketing authorizations.
Treatment
The clinical trial involves the administration of several experimental medications, each with specific pharmaceutical forms, dosages, and routes of administration. **Dapagliflozin** is provided in the form of film-coated tablets. The active substance, dapagliflozin, is of chemical origin. The maximum daily dose is 10 mg, with a total maximum dose of 1820 mg over a treatment period of up to 6 months. The route of administration is oral, and participant compliance will be monitored throughout the study.
**Semaglutide** is administered as a solution for injection. The active substance, semaglutide, is a protein of other origin. The maximum daily dose is 29 µg, with a total maximum dose of 52 mg over a 6-month treatment period. The administration route is subcutaneous injection. Compliance with the dosing schedule will be closely monitored to ensure adherence to the treatment protocol.
**Finerenone** is available in the form of coated tablets. The active substance, finerenone, is of chemical origin. The maximum daily dose is 20 mg, with a total maximum dose of 3640 mg over a treatment period of up to 6 months. The route of administration is oral. Participant adherence to the dosing regimen will be assessed regularly to maintain the integrity of the trial data.
In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The focus is on evaluating the efficacy and safety of the experimental medications in preventing cardiovascular and renal complications in diabetes. The trial will utilize urinary proteomic classifiers to identify patients who may benefit from these treatments, ensuring a personalized approach to intervention.
Efficacy
The efficacy of the clinical trial will be assessed using both primary and secondary endpoints. The primary endpoint focuses on the **feasibility** of using urinary proteomic signatures in clinical practice to identify patients at risk of developing end organ damage. Secondary endpoints include changes in urinary albumin excretion (≥30%), changes in urinary proteomic signatures, and changes in estimated glomerular filtration rate (eGFR) levels (≥30%). These parameters will be measured to evaluate the effectiveness of the intervention in preventing cardiovascular and renal complications in patients with type 2 diabetes.
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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 Criteria
- Heart failure NYHA class IV at screening
- eGFR < 25 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 all three of the study medications or related products
- History of acute pancreatitis within 6 months prior to the screening visit
- Body mass index < 18.5 kg/m2 at the screening visit if the only possible therapy addition at the screening visit is semaglutide
- Type 1 diabetes
- Serum potassium > 5.0 mmol/L at the screening visit if the only possible therapy addition at the screening visit is finerenone
- Addison’s Disease, if the only possible therapy addition at the screening visit is finerenone
- Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone) if the only possible therapy addition at the screening visit is finerenone
- Treatment with a potassium-sparing diuretic (amiloride, triamterene) if the only possible therapy addition at the screening visit is finerenone
- Treatment with other mineralocorticoid receptor antagonist than finerenone (e.g., spironolactone, eplerenone, esaxerenone, canrenone), if the only possible therapy addition at the screening visit is finerenone
- 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
- Severe or proliferative retinopathy or retinal bleeding, macular edema within 6 months prior to the screening visit, if the only possible therapy addition at the screening visit is semaglutide.
- 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 severe abuse of narcotics
- Participant in another intervention study with medicinal product
- Vulnerable (i.e., under guardianship) or mentally incapacitated subjects (i.e., not able to understand and sign the informed consent
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Denmark | Recruiting | 09 Jun 2026 | 26 |
 Spain | Recruiting | 09 Jun 2026 | 20 |
Sites & Investigators
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
DAPAGLIFLOZIN | Test | — | ORAL | 10 | 6 | SUB31650 |
SEMAGLUTIDE | Test | — | ORAL | 9 | 6 | SUB32188 |
DAPAGLIFLOZIN | Test | — | ORAL | 10 | 6 | SUB31650 |
SEMAGLUTIDE | Test | — | ORAL | 14 | 6 | SUB32188 |
SEMAGLUTIDE | Test | — | SUBCUTANEOUS INJECTION | 29 | 6 | SUB32188 |
FINERENONE | Test | — | ORAL | 20 | 6 | SUB183743 |
SEMAGLUTIDE | Test | — | ORAL | 9 | 6 | SUB32188 |
FINERENONE | Test | — | ORAL | 20 | 6 | SUB183743 |
SEMAGLUTIDE | Test | — | ORAL | 14 | 6 | SUB32188 |
SEMAGLUTIDE | Test | — | ORAL | 9 | 6 | SUB32188 |