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A study to evaluate the effect of CX11 trometamol monohydrate 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 study is being conducted to evaluate the effect of different doses of CX11 in people living with Type 2 Diabetes Mellitus. This condition is a chronic disease that affects how the body processes blood sugar. The research focuses on how the medication impacts HbA1c, which is a blood test that shows the average amount of sugar in the blood over the past few months.

Participants in the study will be assigned to receive either CX11 tablets or a placebo. The study follows a randomized and double-blind design, meaning that participants and researchers do not know which treatment is being given to which person. The investigation also looks at other factors such as FPG, which is the measurement of blood sugar after fasting, and changes in body weight and blood pressure.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
participation in the study
The study begins with the randomization process, which means the assignment to a specific group is decided by chance, similar to a coin toss.
One of three groups will be assigned: a group receiving cx11 tablets, a group receiving a 40 mg placebo, or a group receiving an 80 mg placebo. a placebo is a pill that looks like the medication but contains no active medicine.
Step 2
medication administration
The assigned tablets are taken by oral route, which means swallowing them by mouth.
The cx11 tablets are the active medication being tested for the management of type 2 diabetes mellitus, a condition where the body has difficulty managing blood sugar levels.
Step 3
monitoring and evaluation
The effectiveness of the treatment is measured by changes in hba1c, which is a blood test that shows the average blood sugar levels over the past few months.
Other measurements include time in range, which is the percentage of time blood sugar stays within a healthy target level using a continuous glucose monitor (a device that tracks sugar levels constantly).
Additional monitoring includes fasting plasma glucose (blood sugar levels measured after not eating), body weight, systolic and diastolic blood pressure (the pressure in the arteries), and tracking any instances of hypoglycemia (low blood sugar levels).

Who can join the trial?

9 criteria

Both men and women who are between 18 and 75 years old can participate.
You must have been diagnosed with Type 2 Diabetes (a condition where the body cannot properly control blood sugar levels) for at least 6 months.
Your HbA1c, which is a blood test that measures your average blood sugar levels over the past few months, must be between 7.0% and 10.5%.
Your BMI (Body Mass Index, a measure of body fat based on your height and weight) must be between 23 and 50 kg/m2.
You must have had a stable body weight, meaning your weight has not changed significantly, for the 3 months before being assigned to a study group.
You must be taking a steady dose of metformin (a common medicine used to lower blood sugar), either by itself or along with a steady dose of an SGLT2 inhibitor (a type of medicine that helps the kidneys remove sugar from the body through urine) for at least 3 months.
You and your partner must not plan to become pregnant or donate sperm or eggs during the study or for 90 days after the last dose is taken.
Women who are able to have children must use highly effective contraception (methods used to prevent pregnancy, such as birth control) for at least 6 months before the study, during the study, and for 90 days after the last dose.
A negative pregnancy test must be confirmed within 24 hours before taking the first dose of the study medicine.

Who cannot join the trial?

21 criteria

People with type 1 diabetes, which is a condition where the body does not produce insulin, or a history of ketoacidosis, a dangerous buildup of acids in the blood, cannot join.
People who have used GLP-1 receptor agonists (a type of medicine used for diabetes) in the last 6 months or have ever used the study drug CX11 cannot participate.
People who have used insulin to manage their blood sugar levels in the last 12 months are excluded.
People who have experienced more than one episode of severe hypoglycemia (dangerously low blood sugar) and are aware of the symptoms in the last 6 months cannot join.
People with a history of cardiovascular events, such as heart attacks or strokes, are not eligible.
People with advanced heart failure, a condition where the heart cannot pump blood well enough to meet the body's needs, cannot participate.
People with significant ECG abnormalities, which are unusual patterns in the electrical activity of the heart, are excluded.
People with poorly controlled hypertension, which is high blood pressure that is not well managed, cannot join.
People with pancreatic or gallbladder disorders are not eligible.
People with uncontrolled thyroid dysfunction, which means the thyroid gland is not working properly, cannot participate.
People with a personal or family history of specific cancers or any recent or active malignancy (cancer) are excluded.
People with serious chronic gastrointestinal diseases, which are long-term problems with the digestive system, cannot join.
People with active liver disease are not eligible.
People with an estimated glomerular filtration rate (eGFR) of less than 60, which is a measure used to check how well the kidneys are filtering blood, cannot participate.
People with ALT or AST levels (liver enzymes that show if the liver is damaged) that are more than 2.5 times the normal limit are excluded.
People with total bilirubin levels (a yellow substance in the blood) more than 1.5 times the normal limit, unless they have Gilbert's syndrome (a common, harmless liver condition), are ineligible.
People with serum amylase or lipase levels (enzymes that can indicate issues with the pancreas) more than 1.5 times the normal limit cannot join.
People with fasting triglycerides (a type of fat in the blood) higher than 5.7 mmol/L are excluded.
People with thyroid stimulating hormone (TSH) levels more than 1.5 times the normal limit cannot participate.
People with calcitonin levels of 20 ng/L or higher are not eligible.
People with hemoglobin (the protein in red blood cells that carries oxygen) levels below 110 g/L for men or below 100 g/L for women are excluded.

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Verified sites

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

FutureMeds Kraków
Verified
Cracow, Poland
Futuremeds Sp. z o.o.
Responsive
Wroclaw, Poland
Futuremeds Łódź
Responsive
Lodz, Poland
Synexus Polska Sp. z o.o.
Verified
Wroclaw, Poland
Synexus Polska Sp. z o.o.
Verified
Poznan, Poland

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Investigated drugs

CX11 is an experimental medication being tested as a tablet taken by mouth to see how well it helps manage blood sugar levels in people with type 2 diabetes.

What is already known about the treatment

CX11 Trometamol Monohydrate - This medication is taken orally in the form of a tablet and is currently being studied in clinical trials to determine its effectiveness. It is being investigated for the treatment of Type 2 Diabetes Mellitus to help manage blood sugar levels. At a molecular level, it works by targeting specific processes in the body to improve how glucose is handled, classifying it as an experimental metabolic regulator.

Investigated diseases

Type 2 Diabetes Mellitus - This is a condition where the body cannot properly use insulin or does not produce enough of it. Over time, this leads to high levels of sugar in the bloodstream. The condition often develops gradually as cells become less responsive to insulin. As it progresses, the body's ability to regulate blood sugar levels diminishes. This metabolic imbalance can affect various parts of the body over time.