Urgent appeal to save diabetes trial

First published in Mojo October 2012

Professor Len Harrison of the Walter and Eliza Hall Institute of Medical Research leads the investigation into a nasal vaccine for Type 1 diabetes. Picture supplied by WEHI

Professor Len Harrison of the Walter and Eliza Hall Institute of Medical Research leads the investigation into a nasal vaccine for Type 1 diabetes. Picture supplied by WEHI

SPECIALISTS developing a vaccine to prevent diabetes fear their funding could be cut due to slow participation in a medical trial.

Unless 6000 new participants can be found, the intra nasal vaccine trial (INIT II) may be at risk.

Researchers have made an urgent nationwide call for relatives of people with type 1 diabetes to come forward for a blood test – the first step towards taking part.

The vaccine is aimed at preventing the onset of diabetes in people aged four to 30. It costs around $5000 a year to treat a type 1 diabetes sufferer. With 130,000 Australians affected, that means an annual minimum cost of $600 million.

Professor Len Harrison of the Walter and Eliza Hall Institute of Medical Research (WEHI) in Melbourne said he needed another 6000 participants on top of the 7500 people screened so far.

“There are literally thousands, probably 400,000 people (relatives of people with type 1 diabetes) in Australia who could participate in this trial.”

“We need them tomorrow because the people who are paying for this trial are screaming,” Professor Harrison said.

“We are looking for people whose risk of getting diabetes is roughly 40-50 per cent over five years because our statistics are based on that.”

In the first phase of the trial, blood is tested for the presence of immune antibodies that kill insulin-producing cells in the pancreas, affecting the body’s ability to process sugar.

“More importantly they have tests of their ability to make insulin,” Professor Harrison said.

Two per cent – 70 people – of the 7500 already screened showed a high risk of developing type 1 diabetes and have been offered a place in the second stage. A further 60 participants, who test positive to the immune antibodies and fit the trial’s risk category, are required by the end of 2013.

These participants will be randomly divided into an active arm and placebo arm of treatment and take a nasal spray vaccine once a week for 12 months.

A third party outside the trial and the pharmacy department who dispense the treatment are the only people who know which participants receive the active vaccine.

“We don’t want to be biased in the way we treat them,” Professor Harrison said.

For the treatment to be statistically significant, the trial must show the risk of acquiring type 1 diabetes has been more than halved.

Professor Harrison is hopeful. He said: “We can offer them the possibility that they could never get diabetes by taking the vaccine.”

The increasing incidence of type 1 diabetes is recognised in a study by the Australian Institute of Health and Welfare. Professor Harrison agrees that up to 4000 people are diagnosed with type 1 diabetes annually. He also notes that 5-10 per cent of people over the age of 30 presenting with symptoms of type 2 diabetes actually have a “slightly progressive type 1 diabetes” called Latent Autoimmune Diabetes in Adults (LADA) where the symptoms are slow to develop.

The INIT II trial began in 2006 and is jointly funded by the National Health and Medical Research Council (NHMRC) and the Juvenile Diabetes Research Foundation (JDRF).

In March this year, the Federal Minister for Health, Tanya Plibersek and the Minister for Science and Research, Senator Chris Evans, jointly announced in a statement an allocation of $2.9 million in funding to the NHMRC to help boost access to clinical trials of new drugs, treatments and medical procedures. Ms Plibersek said the funding would support the administration of the NHMRC Clinical Trials Centre and the expansion of the centre’s Australia New Zealand Clinical Trial Registry (ANZCTR) with the intention of increasing trial participation rates.

However, no specific funding has been made available for continued research into the prevention of the INIT II trial in the 2012-13 Health and Ageing budget.

On-line registration for the type 1 diabetes prevention trial is available at http://www.stopdiabetes.com.au or telephone 1300 138 712. Details of interstate trial partners are listed on the website.

A type 1 diabetic’s story

Kim Henshaw with daughter Aspen 6 and son Jarrah 1

Kim Henshaw with daughter Aspen 6 and son Jarrah 1

Kim Henshaw was rushed to hospital two days after celebrating her eighth birthday. She was close to falling into a diabetic coma. At the time, her parents attributed her flu-like symptoms to exhaustion following a weekend of celebrations. That was twenty-five years ago.

“I got very sick very quickly between 12 and 24 hours,” she said. “Mum took me to the GP and he sent me straight to the Royal Children’s Hospital.”

“I had lost a bit of weight as well in a week or two weeks leading up to being diagnosed” she said. “The onset of type 1 diabetes was very quick.”

Fear and the need to cope with the news that their daughter had a chronic and life-threatening health issue, led Ms Henshaw’s parents to find as much information about it as they could. They quickly became experts in the management of their daughter’s diabetes.

That meant multiple daily doses of insulin injections and finger prick blood testing to test her blood sugar levels, a strict diet based on mealtimes set at 5.30pm every day, and the traffic light guide to eating.

Red: foods to be avoided, like sweet biscuits and ice cream. Amber: foods to be eaten only occasionally. Green: everyday foods, like fresh fruit and veggies, grains and pastas.

“Every single bit of food I ate was counted and accounted for.”

Type 1 diabetes, also known as juvenile diabetes, affects around 130,000 Australians. It is an autoimmune disease that causes the body’s immune system to destroy beta cells within the pancreas that produce the insulin hormone, which affects the body’s ability to process sugar. The insulin-producing cells are unable to maintain blood glucose at levels that are required to keep the body healthy.

Since Ms Henshaw was diagnosed, experts have developed a second option for administering insulin. The insulin pump is the size of a pager and is attached to the body to deliver regular doses of insulin to keep blood glucose levels within the normal range. This method allows for a more flexible lifestyle – and avoids the need to inject.

Type 1 diabetes can affect children with no family history of the disease, as in the case of Ms Henshaw. It can also be genetic.

Ms Henshaw, her parents and sister, and at times extended family members, have regularly participated in clinical trials. But Ms Henshaw struggled with the decision to allow her daughter Aspen, six, to take part in the nasal insulin vaccine trial.

Aspen tested antibody negative and she will be retested in the next 12 months. Ms Henshaw’s son Jarrah, one, will have a blood test at the age of four.

“If either of my kids were to be tested as positive, I know after the initial test there is often another two blood tests that need to be performed to drill down on what the antibodies exactly are testing positive to,” Ms Henshaw said.

In the event of a positive test, Henshaw and her husband would explain to their children that the intranasal spray is a medicine.

But this is one of the reasons for her initial hesitation in registering Aspen for the trial. She said children expected medicine to cure illness. “But what if it doesn’t?”

The nasal vaccine trial does not guarantee that taking part will prevent the onset of symptoms, and some parents have chosen not to register their “at risk” children, preferring to wait to see whether symptoms arise.

Ms Henshaw believes that those parents “don’t want to know until they have to deal with it…it is quite a sensitive topic”.

She said: “I was brought up to learn that if you were living with a chronic illness you have a certain level of responsibility to contribute to research.”

Meanwhile Ms Henshaw, who works for Diabetes Australia, is developing a program to support children with type 1 diabetes and their families.

“There is so much to be done; we just need to prioritise it and take it step by step.”

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