Considering treatment options for a recent type 1 diabetes diagnosis?
Age from 18 up to and including 44
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Considering treatment options for a recent type 1 diabetes diagnosis?
Why is this study important?
The IMCY-T1D-003 study is a study to test a new experimental drug for the treatment of type 1 diabetes. The drug name in this study is IMCY-0098, this is a synthetic small protein made in the laboratory, which is being developed with the hope to stop the body’s own immune system attacking and destroying the insulin-producing cells. When injected, it is expected to induce new immune cells that would specifically destroy the bad immune cells responsible for the damage to the pancreas.
Who can take part?
- Aged 18-44 years old;
- Diagnosed with type 1 diabetes;
- You are on insulin treatment;
- First insulin injection in the last 9 weeks;
What happens if you decide to participate?
- 7 treatment visits and 5 follow-up visits
- 2 injections of IMCY-0098 at each treatment visit
- Total study participation will last approximately 2 year
Next to the classical assessments to evaluate your health (vital signs, physical examination, side effects, …), the following specific tests will be performed:
- Mixed Meal Tolerance Test (MMTT)
- Numerous blood samples for immune analysis
- Follow-up of potential injection site reactions
- Dry Blood Spot (DBS) at home
You will receive:
All study-related visits, tests, and drugs will be provided at no cost. For taking part in this research, you may be paid up to a total of $1,500.
(The breakdown of this compensation per visit and expenses will be explained by the hospital research team.)
How to apply
Please register on this website and answer the questions below. If you are eligible, one of the participating clinics will contact you to schedule an appointment, and will also be happy to answer any questions you may have.
Diabetes is a disease that affects how the body uses glucose, the main type of sugar in the blood.
After a meal, our body digests the food we eat into glucose and other nutrients we need.
The glucose level in the blood rises and triggers the islet cell of the pancreas to make the hormone insulin and to release it into the bloodstream.
In most people with type 1 diabetes, the pancreas loses its ability to make insulin because some cells of the body's own immune system mistakenly attack and destroy the cells that produce insulin (islet beta-cells).
Insulin works like a key that opens the doors to cells and lets the glucose in. Without insulin, glucose cannot get into the cells and so it stays in the bloodstream. As a result, the level of sugar in the blood climbs higher than usual; this is called hyperglycemia. The long-term complications can be lifechanging and even life-threatening and include heart and circulatory disease, nerve damage, kidney damage, eye changes, and more likely to get severe bacterial and fungal infections.
IMCY-0098, the study drug, is a synthetic peptide (small protein) made in the laboratory, which is being developed with the hope to stop the body’s own immune system attacking and destroying the insulin producing cells. When injected, it is expected to induce new immune cells that wouldspecifically destroy the bad immune cells responsible for the damage to the pancreas.
To increase the immune response to IMCY-0098, the solution with the peptide will also contain aluminium hydroxide. This compound is present for the same reason in almost all vaccines used for routine immunisation of infants, children, and adults.
Imcyse is a clinical-stage biotech company headquartered in Liège, Belgium. Imcyse’s mission is to develop novel, disease-specific immune therapies to cure and prevent severe, chronic auto-immune, inflammatory and allergic diseases.
What is a clinical study?
- A clinical study is a scientific study on how a new or existing medicine, product, procedure or treatment works in people.
- Through clinical studies, doctors can find new and better ways to prevent, detect, diagnose, control and treat illnesses.
- All clinical studies are carefully monitored and regulated to ensure participant well-being.
- Participating in a clinical study is completely voluntary and will not affect the normal standard of care you receive.
Why is this study being done?
The first step when a company wants to develop a study drug on human is to show that the drug is safe.
IMCY-0098 was previously tested on recently diagnosed type 1 diabetes patients in the first clinical study between August 2017 and April 2019 to collect information on the safety of IMCY-0098. Here, 3 different amounts (“doses”) of drug were tested, and patients received 4 administrations of the dose they were allocated to. In total, 31 patients received IMCY-0098, and 10 additional patients received a placebo. The patients were followed up for 6 months initially and then for an additional 6 months between April and October 2019 to collect more safety information.
All results show so far that the study drug can be safely and satisfactorily tolerated for about 40 weeks after the last treatment.
The next step is now to test the best dose and the best number of injections (=regimen) of the drug that could give you benefit with your disease. This is the primary purpose of this study.
As for any other study, safety information will be collected during the study for all the participants.
This clinical study will be run with the support and endorsement of a European consortium fully dedicated to type 1 Diabetes research: INNODIA.
How is this study being done?
To participate in this study, patients must be diagnosed with type 1 diabetes within a maximum of 9 weeks and have insulin treatment. It is, however, essential to be aware that starting treatment as soon as possible after the diagnosis is critical, so earlier than 9 weeks is better whenever possible. Patients must be at least 18 years of age and cannot be older than 44. There are a few reasons which may make a patient ineligible for this study, and the study doctor will review these with you.
84 patients will join the study to learn more about the best dose of the test drug, to understand better how it works and to demonstrate if the study drug is helpful to treat type 1 diabetes.
Two doses of IMCY-0098 will be tested and will be compared to a placebo. Patients will be randomly assigned to one of the three treatment arms: placebo, IMCY-0098 450 µg or IMCY-0098 1350 µg. There will be the same number of patients in each arm. Each patient will have two chance out of three to receive the study drug.
Randomly assigned means that a computer will be used to determine which treatment patients will receive, and neither you nor the study doctor can choose a treatment. This study is double-blind. That means that the study doctor, study staff and all the patients who take part will not know which treatment was assigned during the study. Patients will be told which treatment they received at the end of the study (or sooner if there is a medical need). The study drug (IMCY-0098 or placebo) will be given subcutaneously, meaning that it will be injected just under the skin, as two injections, one in each arm. After each series of injections, you will need to remain at the hospital for at least one hour. The study doctor and study staff can then check that nothing unexpected has occurred after administration of the study drug. All patients will receive up to 6 series of injections of IMCY-0098 or placebo with a 2-week interval between each series of injections and an additional boost administration after 6 months. The boost administration will be the same as your previous administration.