DIAGNODE-3 Trial

The elements presented on this page are not an exhaustive list of information relating to the clinical trial. The inclusion and exclusion criteria have been simplified and should be interpreted by a physician. For more information, please visit: CTIS website for Diagnode-3

• Official Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype (DIAGNODE-3) 
• Study Type: Interventional  (Clinical Trial)
• Estimated Enrollment: 330 participants
• Allocation: Randomized
• Description and Purpose: 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.
  
  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. 
• Duration of Participation: 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. 

Recruitment for this study is only open to people who meet these criteria.

Highlighted Inclusion: 

• Participants who were diagnosed with type 1 diabetes within the last 6 months
• Age: 12 to <29

Highlighted Exclusion: 

• Exclusion criteria will be evaluated by the principal investigator at the study center

The primary objective is to evaluate the effect of three doses of Diamyd compared to placebo in terms of (1) beta cell function; and (2) glycemic control in adolescents and adults recently diagnosed with T1D, who carry the HLA DR3-DQ2 haplotype and have antibodies against glutamic acid decarboxylase.

Interested in more Information? Reach out! 

• Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic
  Principal Investigator: MUDr. Zuzana Vlasakova
  Contact: zuvl@ikem.cz

• University Hospital in Motol, Prague, Czech Republic
  Principal Investigator: Prof. Zdenek Sumnik
  Contact: Lukas.plachy@fnmotol.cz

• Diabeter Nederland, Rotterdam, Netherlands
  Principal Investigator: Dr. Theo Sas
  Contact: onderzoek@diabeter.nl

• Hospital Universitario Cruces, Barakaldo, Spain
  Principal Investigator: Dr. Itxaso Rica Echevarria
  Contact: itxaso.ricaechevarria@osakidetza.eus

• Hospital Universitario Ramón y Cajal, Madrid, Spain
  Principal Investigator: Dr. María Nattero Chávez
  Contact: marialia.nattero@salud.madrid.org

• Hospital Universitario Virgen Macarena, Sevilla, Spain
  Principal Investigator: Dr. María Asunción Martínez Brocca
  Contact: mlgg.investigacionmacarena@hotmail.com

• Skåne University Hospital Malmö, VO Paediatrics, Malmö, Sweden
  Principal Investigator: Dr. Annelie Carlsson
  Contact: anette.sjoberg@med.lu.se

This does not mean that all INNODIA Clinical Trial Sites will participate in this specific study.
Some additional sites that are not part of the INNODIA Network may run this study too.
A complete list of participating sites can be found on CTIS website.

Sponsors and Collaborators

Diamyd Medical