Intranasal Insulin Trial (INIT II)
The INIT II trial is now recruiting in Australia and New Zealand! Visit the INIT II website at www.stopdiabetes.com.au/ to register.
Type 1 diabetes is a condition in which the immune system reacts against the insulin-producing beta cells in the pancreas, eventually destroying the beta cells and causing a lack of insulin. Without the hormone insulin, the cells of the body are unable to use glucose and the level of glucose in the blood increases and causes symptoms of diabetes.
The aim of the INIT II trial is to determine if exposure of the immune system in the mucus membranes to insulin, by treatment with intranasal insulin, will stop the immune reaction and further loss of beta cells. This could prevent diabetes and the need for insulin injections. The intranasal insulin acts only on the mucus membranes and is not absorbed into the body. Insulin given this way does not affect blood glucose and will not cause hypoglycaemia (“hypos”).
Research on mice that develop type 1 diabetes shows that exposure of the mucus membranes to insulin by treatment with intranasal insulin acts like a vaccine to induce protective immune cells that counteract the “bad” immune cells that damage the beta cells. In a recently-completed trial in children and young adults at risk type for type 1 diabetes, insulin given via a nasal spray was found to be safe and to cause immune changes similar to those in the mice that were protected from getting diabetes. It is now important to prove that along with these immune changes we can preserve beta-cell function and stop progression to diabetes.