Study design
diabetes
TOLERANCE, DIABETES
DIAGNODE-2 study was a two-arm, multicenter, randomized, double-blind, placebo-controlled trial (NCT03345004) performed at 18 diabetes clinics in the Czech Republic, the Netherlands, Spain, and Sweden as described before (Three intralymphatic injection with 4 μg GAD-alum (Diamyd Medical, Stockholm, Sweden) on days 30, 60, and 90 and 2,000 IE oral vitamin D daily from day 1 to 120.Three intralymphatic injection of placebo on days 30, 60, and 90 and oral placebo for vitamin D daily from day 1 to 120.Patients received 3 injections (1 month apart) of GAD-alum or Placebo into an inguinal lymph node administrated by using ultrasound needle guide, and in addition vitamin D or placebo if serum level of vitamin D was <100 nmol/L (40 ng/mL) at screening.All patients were evaluated on day 1 (baseline), 1, 2, 3, 6 and 15 months with clinical examination and blood samples. Mixed Meal Tolerance Test (MMTT) (HLA genotyping for all patient was included as an amendment to the original clinical study protocol ahead of treatment unblinding. Individuals genotyping for HLA DR3DQ2 (defined as DRB1 * 03, DQB1 * 02: 01) haplotype at screening were performed centrally by Synlab Pharma Institute (Munich, Germany), using a sequence-specific oligonucleotides kit (One Lambda) (The study was approved by the relevant regulatory authorities and research ethics boards of the participating sites and countries. All participants and their parents/caregivers gave their consent after oral and written information.