This trial is closed for participation.

Considering treatment options for a recent type 1 diabetes diagnosis?

  • Gender Both
  • Age from 18 up to and including 44

Considering treatment options for a recent type 1 diabetes diagnosis?

 

Why is this study important?

The IMCY-T1D-003 study is a clinical trial to test a new experimental drug for the treatment of type 1 diabetes. The drug in this trial is called 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
  • You received your first insulin injection less than 9 weeks ago 

 


What happens if you decide to participate?

  • 1 screening visit
  • 7 treatment visits and 5 follow-up visits
  • 2 injections of IMCY-0098 at each treatment visit
  • Total trial participation will last approximately 2 years

 

Besides the standard 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) sampling at home

 

 

You will receive:

If your participation in this study will result in loss of earnings, the following compensation will be provided with reimbursement as follows: £50 for the screening visit and at visits 1 to 5 and visit 8 and £75 for the randomization visit and visits 6, 7, 9, 10 and 11. Proof of loss of earnings will be required.

All study participants will be paid reasonable travel and refreshment expenses. ‘Reasonable’ travel expenses means standard class public transport/taxi costs. A mileage allowance will be reimbursed for the use of private transport. Travel and refreshment receipts, where applicable, must be provided. Alternatively, if available at your hospital, you may wish to use “Greenphire” a travel service, which will allow you to book your travel arrangements and arrange for these to be paid directly, without any “out-of-pocket” expenses to you.

 

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 they 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 cells 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 hyperglycaemia. The long-term complications can be lifechanging and even life-threatening and include heart and circulatory disease, nerve damage, kidney damage, eye changes, and increased risk of severe bacterial and fungal infections. 

The trial drug, IMCY-0098, 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 would specifically 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 Angleur, Belgium. Imcyse’s mission is to develop novel, disease-specific immune therapies to cure and prevent severe, chronic autoimmune, inflammatory and allergic diseases.

What is a clinical trial?

  • A clinical trial is scientific study to test how a new or existing medicine, product, procedure or treatment works in people.
  • Through clinical trials, doctors can find new and better ways to prevent, detect, diagnose, control and treat illnesses.
  • All clinical trials are carefully monitored and regulated to ensure participants’ well-being.
  • Participating in a clinical trial is completely voluntary and will not affect the normal standard of care you receive.

 

Why is this trial being done?

The first step when a company wants to develop a drug for human trials is to demonstrate that the drug is safe.

IMCY-0098 was previously tested on recently diagnosed type 1 diabetes patients in the first clinical trial between August 2017 and April 2019 to collect information on the safety of IMCY-0098. In that trial, 3 different doses of the drug were tested, and patients received 4 injections of thedose they were assigned. In total, 31 patients received IMCY-0098, and 10 additional patientsreceived a placebo. The patients were initially monitored for 6 months, and then for an additional 6months between April and October 2019 to collect more safety information.

All results so far show that the trial drug can be safely and satisfactorily tolerated for about 40weeks 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 be beneficial to diabetic patients. This is the primary purpose of this trial.

As with any other trial, safety information will be collected for all the participants during the trial.

This clinical trial will be run with the support and endorsement of a European consortium fully dedicated to type 1 Diabetes research: INNODIA.

 

How is this trial being done?

To participate in this trial, patients must have been diagnosed with type 1 diabetes no more than 9 weeks before they join the trial and they must receive insulin treatment. However, starting treatment as soon as possible after the diagnosis is critical, so joining the trial within less than 9 weeks of the diagnosis is preferable. Patients must be at least 18 years old and cannot be older than 44. There are a few factors which may make a patient ineligible for this trial, and the trial doctor will review these with you.

84 patients will join the trial to learn more about the best dose of the trial drug, to understand better how it works, and to establish if the trial drug is helpful in treating type 1 diabetes.

Two doses of IMCY-0098 will be tested and compared to a placebo. Patients will be randomly assigned to one of the three subgroups (‘treatment arms’): placebo, low dose of IMCY-0098 (450 µg), or high dose of IMCY-0098 (1350 µg). Each of these subgroups will consist of the same number of patients. Each patient will have a chance of two out of three to receive the trial drug.

Randomly assigned means that a computer will be used to determine which treatment patients receive, and neither you nor the trial doctor can choose a treatment. This trial is double-blind. That means that the trial doctor, trial staff and all patients taking part will not know which treatment was assigned during the trial. Patients will be told which treatment they received at the end of the trial (or sooner if there is a medical need). The trial drug (IMCY-0098 or the placebo) will be administered by means of two injections, one in each arm, just under the skin (‘subcutaneous injection’). After each series of injections, you will need to stay in the hospital for at least one hour. The trial doctor and trial staff can then check that nothing unexpected has occurred after administering the trial drug. All patients will receive up to 6 series of injections of IMCY-0098 or the placebo, with a 2-week interval between each series of injections, and an additional boost injection after 6 months. The boost injection will be the same as your previous injections.

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