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Study on Using Dapagliflozin, Semaglutide, and Finerenone to Prevent Heart and Kidney Complications in Patients with Type 2 Diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on individuals with Type 2 Diabetes, a condition where the body struggles to regulate blood sugar levels. The study aims to explore the use of specific protein patterns found in urine to identify patients who might be at risk of developing complications affecting the heart and kidneys. By identifying these risks early, the study seeks to determine which patients could benefit from additional treatments to protect their heart and kidneys.

The treatments being studied include medications such as Dapagliflozin, Semaglutide, and Finerenone. Dapagliflozin is taken orally in the form of film-coated tablets, while Semaglutide is administered through subcutaneous injection, which means it is injected under the skin. Finerenone is also taken orally as a coated tablet. These medications are being tested to see if they can provide additional protection for the heart and kidneys in patients with Type 2 Diabetes.

The purpose of the study is to see if using these urine protein patterns can help guide early intervention and treatment decisions. Participants will be monitored over a period of six months to assess the feasibility of this approach. The study will look at changes in urine protein levels and kidney function to determine the effectiveness of the treatments. This research could lead to more personalized treatment plans for people with Type 2 Diabetes, potentially preventing serious complications before they occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the absence of heart failure, cardiovascular disease, or diabetic kidney disease.
Step 2
Urinary proteomic analysis
A urine sample is collected to analyze proteomic signatures. This analysis helps identify the risk of developing organ damage and determines the need for additional treatment.
Step 3
Medication administration
Based on the urinary proteomic analysis, specific medications are administered:
Dapagliflozin is taken orally. The dosage and frequency are determined by the study protocol.
Semaglutide is administered through a subcutaneous injection. The dosage and frequency are determined by the study protocol.
Finerenone is taken orally. The dosage and frequency are determined by the study protocol.
Step 4
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor health status and medication effects. These visits include assessments of urinary albumin excretion and eGFR levels, which are indicators of kidney function.
Step 5
Completion of study
The study is estimated to conclude by January 31, 2026. Final assessments are conducted to evaluate the feasibility of using urinary proteomic signatures in clinical practice.

Who can join the trial?

7 criteria

The patient must have Type 2 Diabetes.
The patient should not have any clinical signs of heart failure, which means the heart is not pumping blood as well as it should.
The patient should not have any clinical signs of cardiovascular disease, which refers to conditions affecting the heart and blood vessels.
The patient should not have any clinical signs of diabetic kidney disease, which is a condition where diabetes causes damage to the kidneys.
The patient must be an adult, which means they should be 18 years or older.
Both male and female patients can participate.
The patient should not be part of a vulnerable population, meaning they should not be in a group that might need special protection or care.

Who cannot join the trial?

3 criteria

Patients who do not have **Type 2 Diabetes** cannot participate.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent situation, cannot participate.

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Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain

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Investigated drugs

Sodium-glucose-cotransporter-2 inhibitors
are a type of medication used to help lower blood sugar levels in people with diabetes. They work by helping the kidneys remove sugar from the body through urine. In this trial, they are being used to see if they can help protect the heart and kidneys in patients at risk of complications from diabetes.
Glucagon-like-peptide-1 receptor agonists
are medications that help the body produce more insulin when needed and reduce the amount of sugar the liver makes. They also slow down digestion, which can help control blood sugar levels. In this study, they are being tested to see if they can provide additional protection for the heart and kidneys in patients with diabetes.
Non-steroidal mineralocorticoid receptor antagonists
are drugs that help reduce the effects of certain hormones that can cause damage to the heart and kidneys. They are being evaluated in this trial to determine if they can offer extra protection for patients with diabetes who are at risk of developing heart and kidney problems.

What is already known about the treatment

Sodium-Glucose Cotransporter-2 Inhibitors
These medications are typically administered orally in tablet form. They are currently well-established in medical practice and literature for managing Type 2 Diabetes. The main therapeutic indication is to lower blood sugar levels in adults with Type 2 Diabetes. They work by blocking the reabsorption of glucose in the kidneys, leading to increased glucose excretion in urine. They belong to the pharmacological class of antidiabetic agents.
Glucagon-Like Peptide-1 Receptor Agonists
These medications are usually administered via injection. They are recognized in medical literature for their role in treating Type 2 Diabetes. Their primary use is to improve blood sugar control in adults with this condition. They function by mimicking the action of the hormone GLP-1, which increases insulin secretion and decreases glucagon release, thereby lowering blood sugar levels. They are classified as incretin mimetics.
Non-Steroidal Mineralocorticoid Receptor Antagonists
These medications are generally taken orally. They are emerging in medical literature as potential treatments for conditions related to heart and kidney health, particularly in patients with Type 2 Diabetes. Their main therapeutic use is to provide reno-cardiovascular protection by blocking mineralocorticoid receptors, which helps reduce blood pressure and prevent organ damage. They are part of the class of diuretics and antihypertensive agents.

Investigated diseases

Type 2 Diabetes – This is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, leading to elevated blood sugar levels. Over time, high blood sugar can lead to various complications, including damage to the eyes, kidneys, nerves, and heart. The disease often develops gradually and may initially present with mild symptoms or none at all. As it progresses, individuals may experience increased thirst, frequent urination, fatigue, and blurred vision. Managing blood sugar levels is crucial to prevent further complications.