A double-blind, randomized investigator-initiated study to determine the safety and the
effect of Diamyd® on the progression to type 1 diabetes in children with multiple islet cell
autoantibodies
Eligible children are 4 years or older, have positive GAD-antibodies and at least one
additional autoantibody and not yet diabetes.
Objectives:
DiAPREV-IT is the first prevention study with Diamyd®, where the drug is given before onset
of type 1 diabetes.
The primary objective is to demonstrate that Diamyd® is safe in children at risk for type 1
diabetes.
The secondary objective is to evaluate if Diamyd® may delay or stop the autoimmune process
leading to clinical type 1 diabetes in children with ongoing persistent beta-cell
autoimmunity as indicated by multiple positive islet cell autoantibodies.