Study on the Effects and Safety of Ladarixin for Adults and Adolescents with Recent Onset Type 1 Diabetes

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What is this study about?

This clinical trial is focused on studying the effects and safety of a medication called Ladarixin in individuals with Type 1 Diabetes that has recently developed. Type 1 Diabetes is a condition where the body’s immune system attacks the cells in the pancreas that produce insulin, a hormone that helps control blood sugar levels. The study aims to see if Ladarixin can help preserve the function of these insulin-producing cells and slow down the progression of the disease. Participants in the study will either receive Ladarixin or a placebo, which is a substance with no active medication.

The study will involve taking Ladarixin in the form of a hard capsule, with a dosage of 400 mg taken twice a day. The treatment period will last for up to 12 months. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the medication. These check-ups will include various tests to assess how well the insulin-producing cells are functioning and to ensure the safety of the participants.

The main goal of the study is to determine if Ladarixin can help maintain the function of the insulin-producing cells in the pancreas and delay the worsening of Type 1 Diabetes. Additionally, the study will evaluate the safety of Ladarixin in this specific group of patients. Participants will be closely monitored for any changes in their condition and any potential side effects of the treatment. The study will provide valuable information on whether Ladarixin could be a beneficial treatment option for people with recent onset Type 1 Diabetes.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, recent onset of type 1 diabetes, and the presence of specific diabetes-related antibodies.

A fasting C-peptide test is performed to measure the level of a protein that indicates how well the pancreas is producing insulin.

2 randomization and medication

Participants are randomly assigned to receive either Ladarixin or a placebo. This is a double-blind study, meaning neither the participants nor the researchers know who receives the actual medication.

Ladarixin is administered orally in the form of hard capsules. The dosage is 400 mg taken twice a day.

3 treatment phase

The treatment phase involves taking the assigned medication for a specified duration. Regular follow-up visits are scheduled to monitor health and response to the treatment.

Participants continue their usual insulin therapy as needed, and adjustments are made based on regular assessments.

4 monitoring and assessments

Throughout the study, various assessments are conducted to evaluate the effect of the treatment. This includes measuring changes in C-peptide levels, HbA1c levels, and insulin requirements.

Continuous Glucose Monitoring (CGM) is used to track glucose levels over time, providing data on time in range and glucose variability.

5 end of study evaluations

At the end of the study, final evaluations are conducted to assess the overall impact of the treatment on beta-cell function and diabetes progression.

Participants are informed of the study results and any potential implications for their ongoing diabetes management.

Who Can Join the Study?

Male and female patients aged 14-45 years can participate.
Patients must have a recent onset of Type 1 Diabetes, meaning they should receive the first dose of the study medication within 180 days from their first insulin administration.
Patients need to test positive for at least one diabetes-related auto-antibody. Auto-antibodies are proteins made by the immune system that mistakenly target the body’s own tissues. Examples include anti-GAD, IAA (if tested within 10 days of starting insulin therapy), IA-2 antibody, or ZnT8.
Patients must require or have required insulin therapy at some point, either through separate injections under the skin or through a device that continuously delivers insulin under the skin.
Patients should have a fasting C-peptide level of less than 0.205 nmol/L. C-peptide is a substance made in the pancreas, and its level can indicate how much insulin the body is producing.
Patients must have some remaining beta-cell function, shown by a peak stimulated C-peptide level greater than 0.2 nmol/L. Beta cells are cells in the pancreas that make insulin. The test to measure this should not be done within one week after recovering from a diabetic ketoacidosis event, which is a serious diabetes complication.
Patients must be able to follow all study procedures for the entire duration of the study, including attending scheduled follow-up visits and examinations.
Patients must provide written informed consent before any study-related procedures that are not part of standard medical care. For participants under 18, they must give their agreement to participate, and specific consent is needed from adolescents for a detailed analysis of how the drug is processed in the body.

Who Cannot Join the Study?

Patients who have had Type 1 Diabetes for a long time cannot participate. The study is for those with a recent onset of the condition.
Individuals who are not in the specified age range for the study cannot join. The study is for adolescents and adults.
People who are not comfortable with the treatment or have concerns about the safety of the medication being tested should not participate.
Participants who are part of a vulnerable population, meaning they might need special protection or care, may not be eligible.
Both male and female participants are considered, but specific health conditions or factors might exclude someone.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
ASST Fatebenefratelli Sacco	Milan	Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Vrije Universiteit Brussel	Jette	Belgium
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Institut fuer Diabetesforschung Muenster GmbH	Munster	Germany
Diabetologikum DDG Ludwigshafe	Ludwigshafen Am Rhein	Germany
Uivwflaiod Dxhma Sljnz Dy Rlyv Lt Swpfaram	Rome	Italy
Ugivyljroq Mvima Gmfeqsx Oe Ctsmtqzho	Catanzaro	Italy
Sxfatqaqdgawcrfpi fio Dilkpita uqi Emhqydcwrlkkiptzx Ddj mzan Wwewsxwq Krpkcffe	Munster	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	12.01.2021
Germany	Not recruiting	12.01.2021
Italy	Not recruiting	12.01.2021

Trial locations

Investigated drugs:

Ladarixin

Ladarixin is an oral medication being studied for its potential to help preserve the function of beta cells in the pancreas. Beta cells are responsible for producing insulin, which is crucial for regulating blood sugar levels. In this trial, ladarixin is being tested to see if it can delay the progression of type 1 diabetes in patients who have recently been diagnosed and have low beta-cell function. The study also aims to evaluate the safety of ladarixin in these patients.

Investigated diseases:

Type 1 diabetes mellitus

Type 1 Diabetes – Type 1 Diabetes is a chronic condition where the pancreas produces little or no insulin due to the immune system attacking and destroying the insulin-producing beta cells. This disease often begins in childhood or adolescence but can also develop in adults. As the disease progresses, individuals experience high blood sugar levels, which can lead to symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, if not managed properly, it can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The progression of Type 1 Diabetes requires careful monitoring of blood sugar levels and lifestyle adjustments to manage the condition effectively.

Trial ID:

2024-513560-26-00

Protocol code:

LDX0319

NCT ID:

NCT04628481

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects and Safety of Ladarixin for Adults and Adolescents with Recent Onset Type 1 Diabetes

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