INIT II: Vaccination against type 1 diabetes - International study of children and adolescents with high risk of type 1 diabetes
The primary aim of the INIT II trial (intranasal insulin trial) is to prevent type 1 diabetes in children and young adults with a high risk of diabetes with insulin, administered via a nasal spray.
In March 2003 the Diabetes Vaccine Development Centre (DVDC) was founded with the goal of developing a vaccine against type 1 diabetes. In late 2006 DVDC initiated the placebo-controlled study INIT II based on promising predecessor studies in which it was shown to be safe and to induce immune effects.
Nasal insulin works like a vaccine to stimulate a protective type of immune response to insulin. This has been shown to suppress the immune attack on the pancreatic beta cells which causes type 1 diabetes.
The international study is being conducted by the research group of Prof. Dr. Anette-Gabriele Ziegler in Germany. After an initial examination in our study center in Munich the participants will self-administer a nasal spray containing insulin or a placebo each morning for one week and then once a week for 12 months. Check-up visits will take place in Munich every three months during the treatment year, then every six months for a further maximum of ten years.
Anyone who is aged between four and 30, has type 1 diabetes in his or her family and at least two positive islet autoantibodies, but not yet afflicted with diabetes, can potentially participate in the INIT II Trial.
Contact person: Dr. med. Minna Harsunen
Tel. 089 / 3187 - 4796
E-Mail: mailto:minna.harsunen@lrz.tu-muenchen.de