• Hikers downhill

    Recently diagnosed with type 1 diabetes ?

    Consider taking part in the DIAGNODE-3 trial


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

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The DIAGNODE-3 trial will investigate whether an investigational drug called Diamyd® (rhGAD65) is able to preserve the body’s own insulin-producing capacity by halting or delaying the autoimmune attack on the insulin-producing cells (beta cells) in the pancreas. Sustained beta cell function is associated with better blood sugar balance and a lower risk of low blood sugars (hypoglycaemia), ketoacidosis and chronic complications.

We are recruiting patients recently diagnosed with type 1 diabetes who have the HLA haplotype DR3-DQ2, a certain genetic risk for type 1 diabetes. Participants will be initially screened to see if they carry this HLA genotype and can therefore take part in the study.

Qualified participants will enter a 2-month treatment period and be assigned at random. The study drug Diamyd® or placebo (a treatment without the active ingredient), will be given through an injection into a lymph node in the groin during ultrasound imaging by an experienced specialist 3 times during the 2 months. The treatment will be determined at random and neither the study participant nor the study doctors know which treatment is given.

Participants receiving these 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 shot under the skin. The study will include a 22-month follow-up period. During this time the study team will monitor the participants’ health closely.

Diamyd® has been studied for over 20 years in 15 clinical trials with over 1500 patients. 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