Hydroxychloroquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At-Risk for Type 1 Diabetes Mellitus

HUMAN CLINCAL TRIAL The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo-controlled clinical trial. All participants will receive close monitoring for progression of T1D. Participants will receive hydroxychloroquine or placebo and close monitoring for progression to Stage 2 (abnormal glucose tolerance) or Stage 3 (clinically overt) T1D. Objective To assess the efficacy, safety and mode of action of hydroxychloroquine to prevent progression from Stage 1 to Stage 2 or Stage 3 of T1D. Primary Outcome The primary objective is to determine whether intervention with hydroxychloroquine will prevent or delay the progression from Stage 1 (normal glucose tolerance) to Stage 2 (abnormal glucose tolerance) or Stage 3 (clinically overt) T1D.