DiAPREV-IT is the first prevention trial with DiamydTM, the alum formulated GAD65 “vaccine”, in children with positive islet cell autoantibodies but not yet diabetes. In the investigator initiated, placebo controlled, and double blind study, children from 4 years of age with positive GAD65-antibodies and at least one more positive islet cell autoantibody will participate. The children are recruited from the DiPiS and TEDDY studies as well as from TrialNet.
DiAPREV-IT started in April 2009 and the enrollment is now completed. Of a total of 50 children, half (n=25) will receive two doses of DiamydTM and half (n=25) will receive two doses of placebo. The children are followed for 5 years with repeated glucose tolerance tests (IvGTT and OGTT) and physical examinations. All visits are located at the CRC, SUS Malmö. Placebo children developing diabetes will receive active drug at the onset of diabetes.
Principal investigator: Helena Elding Larsson, MD, PhD, firstname.lastname@example.org
Research nurse: Caroline Nilsson, Caroline.N.Nilsson@, 040-391181 skane.se
DiAPREV-IT is supported by The Skåne County Council for Research & Development, The Swedish Diabetes Association, The Childhood Diabetes Foundation and The UMAS Funds. We also collaborate with Diamyd Medical AB.
Last updated: February 6, 2017
Website contact: LUDC webteam