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

Primary Objective

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.

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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 12 and <29 years old - Possess the HLA DR3-DQ2 haplotype - Diagnosed with T1D /= 0.12 &
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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