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Study on Fluasterone for Managing High Blood Sugar in Adults with Cushing's Syndrome

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What is this trial about?

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

This clinical trial is focused on studying Cushing's syndrome, a condition where the body produces too much of the hormone cortisol, leading to various health issues, including high blood sugar levels. The study will test the effectiveness and safety of a new treatment called Fluasterone Buccal Tablet. This medication is designed to be taken by placing it against the inside of the cheek, allowing it to dissolve and enter the bloodstream. The trial will also use placebo buccal tablets for comparison.

The purpose of the study is to determine how well the Fluasterone Buccal Tablet can control high blood sugar levels in adults with Cushing's syndrome. Participants will be involved in a double-blind, placebo-controlled, crossover study, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo at any given time. The study will last for a total of 12 weeks, during which participants will receive both the medication and the placebo at different times.

Throughout the study, participants will have their blood sugar levels monitored, and other health indicators will be assessed to ensure the treatment's safety and effectiveness. The trial aims to provide valuable information on whether the Fluasterone Buccal Tablet can be a beneficial treatment option for managing high blood sugar in people with Cushing's syndrome.

The research process

The trial runs in 6 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 reviewing medical history and current health status.
Eligibility criteria include being between 18 and 75 years old, having a diagnosis related to Cushing's syndrome, and having impaired glucose tolerance or type 2 diabetes with stable treatment for at least 60 days.
Step 2
Baseline measurements
Baseline measurements are taken to establish a starting point for the study. These include blood tests to measure glucose levels and other relevant health indicators.
Step 3
Treatment period 1
The first treatment period lasts for 12 weeks. During this time, participants receive either the Fluasterone Buccal Tablet or a placebo. The medication is taken orally as a buccal tablet.
Regular monitoring occurs to track changes in glucose levels and other health markers. This includes a 2-hour oral glucose tolerance test (oGTT) at week 6 and week 12.
Step 4
Crossover and washout
After the first 12-week treatment period, there is a crossover phase. Participants who received the Fluasterone Buccal Tablet will now receive the placebo, and vice versa.
A washout period may be included to ensure that the effects of the first treatment do not influence the second treatment period.
Step 5
Treatment period 2
The second treatment period also lasts for 12 weeks. Participants continue with the new treatment assigned during the crossover phase.
Monitoring continues with similar assessments as in the first treatment period, including glucose tests and other health evaluations.
Step 6
Final assessment
At the end of the study, a final assessment is conducted. This includes a comprehensive evaluation of health markers to determine the effects of the treatments.
The primary focus is on changes in glucose levels, but other factors such as body composition and liver health are also assessed.

Who can join the trial?

9 criteria

Male or female patients aged 18 to 75 years can participate.
The patient must have read and signed a form that shows they understand the study and agree to participate before any screening tests are done.
The patient must have been checked for the possibility of **Cushing syndrome** within the last 12 months. This means they need to meet 2 out of 3 specific criteria based on European guidelines:
Having high levels of **cortisol** in a 24-hour urine test on two occasions. Cortisol is a hormone that helps control stress and metabolism.
Having an unusual result in a test called the **dexamethasone suppression test**. This involves taking a small dose of a medicine called dexamethasone at night and measuring cortisol levels in the morning. If cortisol is still high, it may indicate a problem.
Having high levels of cortisol in the blood or saliva at midnight before starting the study treatment.
The patient must have been diagnosed with **impaired glucose tolerance** or type 2 diabetes. Impaired glucose tolerance means blood sugar levels are higher than normal but not high enough to be diabetes. Type 2 diabetes is a condition where the body doesn't use insulin properly.
If the patient is taking medication for high blood sugar, the dose must have been stable for at least 60 days before the first screening visit.
If the patient had surgery for **Cushing's Disease** and received medication to replace cortisol afterward, they must have stopped taking this medication for at least one week before the first screening visit.

Who cannot join the trial?

5 criteria

Patients who are not diagnosed with **Cushing Syndrome** cannot participate. **Cushing Syndrome** is a condition where the body has too much of a hormone called cortisol.
Patients who do not have **impaired glucose tolerance** or **diabetes mellitus** cannot participate. **Impaired glucose tolerance** means the body has trouble processing sugar, and **diabetes mellitus** is a condition where the body cannot properly control blood sugar levels.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both **male** and **female** patients are eligible, so gender is not a reason for exclusion.
Patients who are part of a **vulnerable population** are not excluded. A **vulnerable population** includes groups like children, pregnant women, or those unable to give consent, but this study does not exclude them based on this criterion.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hippokration Hospital
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Athens, Greece
Laiko General Hospital Of Athens
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Athens, Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
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Chaidari, Greece

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Investigated drugs

Fluasterone is being studied for its potential to help control high blood sugar levels in adults with a condition known as endogenous Cushing's syndrome. This condition can lead to increased levels of cortisol in the body, which may cause problems with blood sugar control. The medication is administered as a buccal tablet, meaning it is placed in the mouth to dissolve and be absorbed through the lining of the cheek. The goal of using fluasterone in this study is to see if it can effectively manage blood sugar levels in patients who have difficulty controlling their glucose due to this syndrome.

Fluasterone

What is already known about the treatment

Fluasterone – Fluasterone is administered as a buccal tablet, which means it is placed in the mouth between the gum and the cheek, allowing it to dissolve and be absorbed directly into the bloodstream. Currently, it is being studied in clinical trials for its potential use in managing hyperglycemia in adults with Cushing's syndrome. The main therapeutic indication for fluasterone is to help control high blood sugar levels in patients with this condition. At the molecular level, fluasterone is believed to work by modulating steroid hormone activity, which may help reduce the effects of excess cortisol. It is classified pharmacologically as a steroid hormone modulator.

Investigated diseases

Cushing Syndrome – Cushing Syndrome is a condition caused by prolonged exposure to high levels of cortisol, a hormone produced by the adrenal glands. It can result from taking glucocorticoid medications or from the body producing too much cortisol. Common symptoms include weight gain, particularly around the abdomen and face, a rounded face, and skin changes such as bruising and stretch marks. Muscle weakness, fatigue, and high blood pressure are also frequently observed. The condition can lead to complications like impaired glucose tolerance or diabetes mellitus. It progresses gradually, and symptoms may vary in severity among individuals.