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

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Description

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

Details
Age

Child to Adult

Eligibility

- 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

Locations

Barbara Davis Center
Childrens Hospital Colorado

Principal Investigator
Photograph of Taylor Triolo

Taylor Triolo

Study ID

Protocol Number: 21-4544

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