A phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the effect and safety of 400 mg twice a day oral ladarixin in patients with recent onset type 1 diabetes and a low residual β-cell function at baseline.
This research study is looking into a new medication called ladarixin for adults recently diagnosed with Type 1 diabetes. The main goal is to check if this oral medicine (taken by mouth) can help the body's own cells continue to produce insulin, which is often damaged in Type 1 diabetes. We also want to understand if it's safe to use. Participants will be randomly assigned to receive either ladarixin or a 'dummy' pill (placebo) for comparison, and neither they nor their doctors will know which one they are receiving. The study will track changes in insulin production, blood sugar levels, and overall health over several months to understand the medicine's potential benefits.
At a glance
What is this study about?
This study is testing a new oral medicine called ladarixin for people who have been recently diagnosed with Type 1 diabetes. When someone has Type 1 diabetes, their body's immune system mistakenly attacks and destroys the cells in the pancreas that make insulin. Insulin is a vital hormone that helps turn sugar from food into energy. Without enough insulin, blood sugar levels become too high.
The main aim of this study is to see if ladarixin can help protect the remaining insulin-making cells in the pancreas, allowing them to continue producing some insulin. This could potentially help people with Type 1 diabetes manage their condition more easily. The researchers also want to make sure the medicine is safe and doesn't cause too many side effects. This is a 'Phase 2' study, which means it’s an earlier stage of testing, focusing on whether the medicine works and is safe before it can be widely used.
To do this, participants will be randomly chosen to receive either the new medicine or a placebo, which looks identical but has no active ingredient. This is done to fairly compare the effects of the medicine. Neither the patient nor the study doctors will know who is getting which, to keep the results unbiased. Over time, the study will measure how well the pancreas is still making insulin, how blood sugar levels are controlled, and other health markers to understand if ladarixin is a promising treatment for Type 1 diabetes.
Key takeaways
- Tests a new medicine, ladarixin, for recent Type 1 diabetes.
- Aims to see if ladarixin can protect insulin-making cells.
- Participants will receive either the medicine or a 'dummy' pill.
- Neither you nor your doctor will know which you are receiving.
- Involves regular health checks and blood tests over two years.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult (age 18 or older) and have been diagnosed with Type 1 diabetes fairly recently. An important part of joining is having some 'beta-cell function' remaining. This means your body still has some cells that can make a bit of insulin. The study team will check this to see if you qualify.
There might be other specific health requirements or conditions that would prevent someone from joining, even if they meet the age and diagnosis criteria. The study doctors will carefully review your health information to make sure taking part is safe and appropriate for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with Type 1 diabetes fairly recently?
- Do you still have some natural insulin production (the study will check this)?
- Are you able to attend regular clinic appointments for two years?
What does participation involve?
If you decide to take part in this study, you would receive either the study medicine (ladarixin) or a dummy pill (placebo) to take twice a day. You would be expected to have regular visits to the clinic over a period of 24 months (two years). These visits would involve various assessments, such as blood tests to check your insulin production, blood sugar levels, and overall health. You would also have check-ups to monitor your general well-being and any side effects.
Some of the tests might include a special meal test where your blood sugar and insulin (C-peptide) are measured after eating. You might also wear a small device to continuously monitor your blood sugar. The total duration of the study is 24 months, with regular follow-up appointments during this time. The study staff will explain all the details of the schedule, medication, and tests before you decide to participate.
Potential risks and benefits
Locations (3)
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedItaly
Common questions
What is Type 1 diabetes?
Type 1 diabetes is a condition where the body's immune system attacks and destroys the cells in the pancreas that make insulin. This means your body can't produce enough insulin to control blood sugar levels.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks exactly like the study medicine but doesn't contain any active drug. It's used so researchers can fairly compare the effects of the real medicine.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know if you are receiving the real medicine (ladarixin) or the placebo. This is called 'double-blind' and helps make sure the study results are fair and unbiased.
What is C-peptide?
C-peptide is a substance your pancreas makes at the same time as insulin. Measuring C-peptide helps doctors see how much insulin your body is still producing on its own.
How long will the study last?
The study will involve regular visits and check-ups over a period of 24 months, which is two years.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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