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 expected to be completed by April 2011. 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, helena.larsson [at] med.lu.se
Research nurse: Caroline Nilsson, Caroline_N.Nilsson [at] med.lu.se, 040-391181
The study is conducted in collaboration with Professor Åke Lernmark, Professor Sten Ivarsson and the following pediatricians in Skåne: Docent Annelie Carlsson, Lund; MD Elisabeth Cedervall, Ängelholm; Docent Corrado Cilio, Lund; MD Björn Jönsson, Ystad; MD Karin Larsson, Kristianstad; and MD Jan Neiderud Helsingborg.
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.