• Hikers downhill

    Recently diagnosed with type 1 diabetes ?

    Consider taking part in the DIAGNODE-3 trial

Intralymphatic immunotherapy with Diamyd®

SEEKING PARTICIPANTS

  • Diagnosed with type 1 diabetes within the last 6 months
  • 12 - <29 years of age

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ABOUT THE DIAGNODE-3 TRIAL

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.
Interview with former trial participant and Prof. Ludvigsson - DIAGNODE-3

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.

Participation is voluntary, free of charge and the participant may discontinue participation at any time.

The study investigates how the treatment affects the body’s production of insulin

Participants are given an injection of Diamyd® or placebo into a lymph node

Newly diagnosed type 1 diabetes patients have more of their own insulin production left to preserve

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The trial sponsor Diamyd Medical has obtained approval from the competent authorities for conducting the Phase III trial DIAGNODE-3. This patient information is approved by the national Ethics Committees in the countries concerned.

EudraCT Number: 2021-002731-32

NCT number: NCT05018585  

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Partially funded by Breakthrough T1D (formerly JDRF).