Recently diagnosed with type 1 diabetes?

Location trial

Gender Both
Age from 12 up to and including 28

Recently diagnosed with type 1 diabetes and considering participation in a clinical study?

What is the DIAGNODE-3 study?

In the DIAGNODE-3 study, we want to see if the study drug helps preserve the function of the beta cells in the pancreas that make insulin. Studies have shown that those with diabetes who continue to produce their own insulin have fewer issues with low blood sugars and fewer long-term complications. We are studying the effects of the study drug in adolescents and young adults recently diagnosed with type 1 diabetes who carry the genetic human leukocyte antigen (HLA) DR3-DQ2 haplotype. A haplotype is a group of genes, often inherited together and part of your genetic make-up, or DNA.

Who can take part?

You may be eligible to participate in this clinical research study if you:

Are 12 to 29 years of age
Have been diagnosed with type 1 diabetes within the last 6 months
Have the HLA DR3-DQ2 haplotype (this will be tested as part of the study)

The study team will be looking at additional criteria to confirm eligibility for the study

What happens if you decide to participate?

The study will last about 26 months and requires up to 11 study visits as well as follow-up phone calls.

Participation in this study is divided into 4 periods:

Screening
The study team will determine if you are eligible to take part in the study.
Study run-in
Participants will receive vitamin D supplementation (if levels are low) and diabetes education. They will then undergo continuous glucose monitoring and self-report diabetes information in an electronic diary (eDiary).
Treatment
All participants will be randomly assigned (by chance) to receive 3 injections into a lymph node of the study drug or placebo given over 2 months. Neither you nor the study doctor will know which group you are in.
Safety follow-up
The study team will monitor your health for 22 months after the last injection of the study drug.

You will receive:

Participants who qualify for the DIAGNODE-3 study will receive at no cost:

The study drug or placebo
Study-related tests and assessments we do as part of the study
The safety follow-up checkpoints for 22 months following the third injection
Diabetes education
You will be compensated for study-related travel.

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.

ABOUT CLINICAL TRIALS

The DIAGNODE-3 study is what is called a clinical research study. Clinical research studies help doctors and researchers find out whether a study drug is safe and works to treat a certain condition or group of patients.

The doctors in clinical research studies refer to the medicine they are researching as an investigational medicinal product or just investigational medicine. In this DIAGNODE-3 study, the investigational medicine is Diamyd® (rhGAD65) and will be referred to in the rest of this document as the “study drug.”

Every drug has to be tested before people are allowed to use it and doctors can give it to their patients. There is a special group of doctors and individuals with expertise in the disease being studied that make up Data and Safety Monitoring Boards, which are appointed for most larger multi-site research studies of a drug. They oversee and monitor the study to ensure participant safety as well as the validity and integrity of the data.

About the DIAGNODE-3 study

The DIAGNODE-3 clinical trial will investigate whether an investigational drug called Diamyd® is able to preserve the body’s own insulin-producing capacity by halting or delaying the immune system’s attack on the insulin-producing cells (beta cells) in the pancreas. Sustained beta cell function is associated with better blood sugar control and a decreased risk of low blood sugars (hypoglycaemia), ketoacidosis and complications later in life Ketoacidosis is a condition where the blood becomes acidic due to the toxic build up that occurs when the lack of insulin makes the body burn fat for energy instead of sugar.

The clinical trial is open for patients recently diagnosed with type 1 diabetes who have the HLA haplotype DR3-DQ2, a certain genetic risk type for type 1 diabetes. Patients who want to participate will be initially screened (blood sample) to see if they carry these specific genes and are therefore eligible to take part in the trial. The reason the trial is only open to patients recently diagnosed (within 6 months of diagnosis) is because the investigational drug aims to halt or delay the autoimmune attack on the insulin producing cells, the investigational drug is therefore believed to be most effective early in the disease when there is still a substantial amount of insulin producing cells left to save.

Participants will enter a 2-month treatment period and be assigned active treatment or placebo (a treatment without the active ingredient) at random. There is a 2 in 3 chance of receiving active treatment. The treatment will be determined at random and neither the study participant nor the study physician know which treatment is given. The investigational drug Diamyd® or placebo, will be given through an injection into a lymph node in the groin with the help of ultrasound imaging performed by an experienced specialist 3 times over a 2 month period. Local anesthetic cream can be used.

By injecting into lymph nodes the immune system is accessed directly. This means that a low dose can be used, adverse reactions are less likely and the response is often quicker when comparing to injections under the skin. Participants receiving these lymph node injections in previous studies have described it as being no more painful than having a blood sample taken from the arm, or comparable to receiving a vaccination. After the third and final injection, a 22-month follow-up period will follow. During the whole study period the study team will monitor the participants’ health closely.

The investigational drug Diamyd® has been studied for over 20 years in 15 clinical trials with over 1500 participants. All studies have indicated a favorable safety profile for Diamyd®, which means that the participants did not have any serious side effects.

What will you have to do during the DIAGNODE-3 study?

During this study, you will:

Review your medical and medication history
Have physical examinations, including vital signs, height, and weight
Have a variety of assessments like neurological ones testing reflexes, strength, coordination, and balance, and Tanner stages of puberty
Be assessed for any side effects or significant changes since last visit
Provide blood and urine samples for a variety of tests
Receive vitamin D supplementation (only if blood tests show a low vitamin D level)
Receive 3 injections of the study drug or placebo at intervals over 2 months
Receive a Mixed Meal Tolerance Test at 4 of your visits (a common test in type 1 diabetes research studies) to test how much insulin (through your C-peptide level) your body makes after having a liquid meal. This test will take 2 hours and will include 5 blood sample collections
Complete questionnaires about your health
Record and review information in an eDiary
Receive education and instruction on diet and exercise for living with diabetes

About Type 1 Diabetes

If you have type 1 diabetes, your pancreas isn’t producing enough insulin. This is because the immune system has misinterpreted the insulin producing cells (beta cells) in the pancreas as foreign and started attacking these cells. With time, the body’s ability to produce insulin and regulate blood sugar is reduced to the extent that one starts to develop symptoms.

Why do we need insulin?
Insulin is a hormone produced by the beta cells in the pancreas. The beta cells do this to communicate to other cells in the body that there is sugar in the blood that can be used as energy. When the body is not producing enough insulin on its own, treatment with external insulin is required. Without insulin, the sugar gets left in the blood and the body’s cells must get energy from other sources, for example fat. Acidic ketones are formed if the cells burn a lot of fat. High ketone levels are harmful to the body and can lead to the potentially life-threatening condition ketoacidosis, often abbreviated DKA.

What are the symptoms of type 1 diabetes?
Symptoms can include:

Feeling very thirsty
Frequent urination
Feeling very tired
Blurred vision
Fruity smelling breath
Fast weight reduction

How is type 1 diabetes treated today?
People living with type 1 diabetes have to monitor their blood sugar frequently and continuously keep it in check by administering insulin, often with the help of an insulin pen or pump. The disease requires constant vigilance and awareness from the patient. The recent technological advancements in continuous glucose monitors (CGMs) and smarter pens and pumps have eased the burden on type 1 diabetics greatly but they cannot replace a working pancreas. With time, more and more of the residual beta cells that were left at the time of diagnosis are destroyed and the disease becomes more difficult to manage.

About Diamyd Medical

Diamyd Medical develops precision medicine therapies for the prevention and treatment of autoimmune diabetes.

The investigational flagship product Diamyd® is a disease-modifying antigen-specific immunotherapy for the preservation of endogenous insulin production that has Orphan Drug Designation in the U.S. and has been granted Fast Track designation by the U.S. FDA. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset Type 1 Diabetes in eight European countries and in the U.S.

Apply for this trial

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Recently diagnosed with type 1 diabetes?