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 type 1 diabetes (T1D), who carry the human leukocyte antigen (HLA) DR3-DQ2 haplotype and have antibodies against GAD65.
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
- Ages >12 and <29 years old - Possess the HLA DR3-DQ2 haplotype - Diagnosed with T1D = 6 months at screening - Ages >12 and <29 years old - Possess the HLA DR3-DQ2 haplotype - Diagnosed with T1D = 6 months at screening - Capable of providing informed consent - Fasting C-peptide >/= 0.12 & = 1.5 nmol/L - Females of childbearing potential (FOCBP) must agree to avoid pregnancy and have a negative pregnancy test - Possess detectable circulating GAD65 antibodies
Principal Investigator