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A plain-language summary of the goals, design and what participants do
This clinical trial focuses on individuals with Type 2 Diabetes and a condition called Albuminuria, which involves having a higher than normal amount of a protein called albumin in the urine. The study will explore the use of two medications: Empagliflozin and Finerenone. Empagliflozin is a medication that helps control blood sugar levels, while Finerenone is used to protect the kidneys by reducing inflammation and scarring.
The purpose of the study is to see how well these medications can be used together to improve kidney health in people with Type 2 Diabetes. Participants will take either Empagliflozin or Finerenone, or a combination of both, in the form of film-coated tablets. The study will be conducted remotely, meaning participants can take part from their own homes using digital technologies. This approach aims to make it easier for people to participate without needing to visit a clinic frequently.
Throughout the study, participants will be asked to provide urine samples and monitor their blood pressure and body weight. The study will last for several weeks, and participants will be asked to take their medication as directed. The researchers will collect information on how participants feel about taking part in a remote trial and how well they adhere to the treatment plan. The study will also look at changes in kidney function, blood pressure, and blood sugar levels to understand the effects of the medications better.
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
7 criteria
5 criteria
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is a medication used to help lower blood sugar levels in people with type 2 diabetes. It works by helping the kidneys remove glucose from the bloodstream through urine. In this trial, it is being used to see if it can also help reduce albuminuria, which is a condition where there is too much protein in the urine, often a sign of kidney damage.
is a medication that helps protect the kidneys by blocking certain hormones that can cause damage. It is used in this trial to see if it can help reduce albuminuria in patients with type 2 diabetes, potentially slowing down kidney damage and improving kidney health.
Empagliflozin is taken orally and is currently being studied for its effectiveness in reducing albuminuria in patients with type 2 diabetes. It is well-documented in medical literature as a medication that helps manage blood sugar levels. The main therapeutic indication is for type 2 diabetes, where it works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, leading to increased glucose excretion in urine. It is classified as an SGLT2 inhibitor.
Finerenone is administered orally and is under investigation for its potential to lower albuminuria in individuals with type 2 diabetes. It is recognized in medical literature for its role in managing chronic kidney disease associated with diabetes. The primary therapeutic indication is for reducing kidney damage in diabetic patients, achieved by blocking mineralocorticoid receptors, which helps reduce inflammation and fibrosis in kidney tissues. It belongs to the class of non-steroidal mineralocorticoid receptor antagonists.
Albuminuria is a condition characterized by the presence of an abnormal amount of albumin, a type of protein, in the urine. It often indicates that the kidneys are not functioning properly, as they are allowing protein to leak into the urine. This condition can progress gradually, with increasing levels of albumin in the urine over time. It is commonly associated with kidney damage or disease, and can be a sign of underlying health issues such as diabetes or hypertension. Monitoring albuminuria is important for assessing kidney health and function.
Type 2 diabetes 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, the pancreas may not produce enough insulin to maintain normal glucose levels. This condition can develop gradually, often without noticeable symptoms in the early stages. It is commonly associated with lifestyle factors such as diet and physical activity, and can lead to complications if not managed properly.
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