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In March 2003, the National Health and Medical Research Council (NHMRC) jointly funded the Diabetes Vaccine Development Centre (DVDC) in collaboration with the New York-based Juvenile Diabetes Research Foundation (JDRF).
This centre was a $10 million dollar initiative and has been part of a coordinated global effort to develop a vaccine for type 1 diabetes.
In late 2006, the DVDC commenced an exciting clinical trial of a new preventive treatment for type 1 diabetes for young people at risk of developing this condition. This is called the Type 1 Diabetes Prevention Trial (previously known as the intranasal insulin trial, INIT II).
If successful, it could prevent diabetes and the need for daily insulin injections.
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Type 1 Diabetes
A brief summary
Type 1 diabetes, previously known as juvenile or early onset diabetes, is an autoimmune disease in which the body's own immune system destroys the cells that produce insulin. Located in the pancreas, these cells are known as beta cells.
Although rarer than type 2 diabetes, type 1 is more severe, and accounts for approximately 10 - 15 per cent of cases worldwide. That means globally, there are about 20 million people living with it.
There is currently no cure or preventative measure for type 1 diabetes. Patients are dependent for the rest of their lives on regular injections of insulin to control their blood sugar levels. Combined with some conservative lifestyle choices, insulin lets people manage their diabetes, but the control of blood sugar is never perfect.
Patients run the risk of going “high” or “low”, both of which can have serious consequences, including death.
As well as this acute danger, poorly controlled blood sugar levels can be damaging to a number of organs in the long term. Kidney problems (diabetic nephropathy), blindness (diabetic retinopathy), and nerve damage (diabetic neuropathy) are not uncommon.
The main reason for these problems is damage to the small blood vessels. Larger vessels can be damaged too, leading to coronary artery disease (which causes angina or myocardial infarction; "heart attack"), stroke, and peripheral vascular disease. The International Diabetes Foundation estimates that diabetes will cause 3.8 million deaths worldwide in 2007. It is particularly hard for people in poorer countries, who often have to pay the full cost of the insulin they depend on to survive.
Research is ongoing to discover the exact cause of type 1 diabetes, which remains unknown. However, exciting research findings during the past few years have provided new evidence that it may be possible to prevent or delay the onset of type 1 diabetes.
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The Type 1 Diabetes Prevention Study
Key Facts
Rationale for the Study
The first step towards developing type 1 diabetes is the development of an immune response to the beta cells of the pancreas. Once the immune system has antibodies against these cells, it begins to destroy them, until eventually the pancreas can no longer produce insulin.
Initial research showed that inhalation of an insulin solution can prevent the immune system from switching into attack mode, even if it has started producing the antibodies.
The safety of inhaled insulin was tested and proven in a previous human trial, called INIT I (Intranasal Insulin Trial I). The current trial is attempting to prevent the development of type 1 diabetes in people who already have at least two of the telltale antibodies in their blood.
The people being recruited for the study are relatives of people with type 1 diabetes, because they are at most at risk of developing type 1 diabetes themselves.
Key Facts about the Study
The study is referred to as the Type 1 Diabetes Prevention Study. It is a randomised, double-blind, placebo-controlled trial of intranasal insulin in children and young adults at risk of type 1 diabetes.
Key Objectives of the Study
To determine whether intranasal administration of insulin to children and young adults at risk of type 1 diabetes will:
- reduce their rate of development of diabetes;
- prevent expected loss of pancreatic β-cell function;
- improve insulin action;
- stimulate immune responses consistent with the induction of immune tolerance to insulin.
The Type 1 Diabetes Prevention Study
Participation in the Study
Do you have Type 1 Diabetes in the Family?
Anyone that has type 1 diabetes in his or her family can potentially participate in this pivotal study.
If YOU are between the ages of 4 to 30 years and have a relative with type 1 diabetes a simple blood test can determine the likelihood of you also developing type 1 diabetes.
If the test shows that you’re at high risk (i.e. have the critical antibodies), you may be eligible to participate in the study. ONLY 1 in 50 will be eligible to participate, that is why ALL RELATIVES aged between 4 and 30 are urged to have a blood test.
Importantly you could play a crucial role in helping to prevent type 1 diabetes in your children or grandchildren.
Only about two percent of family members who have the blood test will have sufficiently high levels of antibodies that will enable them to participate – this is why it is so critical to encourage as many family members as possible to at least undertake the simple blood test.
In summary, any person aged between 4 and 30 years, is encouraged to register their interest if they have a first-degree (mother, father, brother, sister, son, daughter) or second-degree (grandmother, grandfather, aunt, uncle, niece, nephew, half-sister, half-brother) relative with type 1 diabetes.
The Type 1 Diabetes Prevention Study
The Process
What Do YOU Have To Do To Participate?
Call 1300 138 712 and register for a blood test.
This can be done at any local pathology clinic (close to home) or your local GP.
If the blood test is positive, you will be one of the rare people who can contribute towards this exciting, groundbreaking research. Every individual is critical to ensure that the study can be completed successfully.
Study participants will self–administer the insulin solution or placebo using a nasal spray every morning for one week (7 consecutive days) and then once a week for 12 months. They will then be followed up for a further four years.
The study is taking place at a number of sites across Australia and New Zealand:
- Mater Children’s Hospital, Brisbane
- Women’s and Children’s Hospital, Adelaide
- Princess Margaret Hospital, Perth
- Royal Melbourne Hospital and Royal Children’s Hospital, Melbourne
- Royal North Shore Hospital and Westmead Hospital, Sydney
- Canberra Hospital, Canberra
- Liggins Institute, Auckland
- Christchurch Hospital, Christchurch
The Principal Investigators (specialist doctors) conducting this study are Professor Leonard C. Harrison and Associate Professor Peter Colman, Royal Melbourne Hospital, Melbourne.
This trial has received Ethics Committee approval and will be conducted in conjunction with your usual doctor and should not interfere with any other treatment. All study-specific questions can be addressed at the site or on the telephone.
Study participants travelling to the site will be reimbursed for travel expenses they may incur. Frequent travel to the study site is not required.
Type 1 Diabetes Prevention Study
Frequently Asked Questions
What is a Clinical Trial?
Answer: A clinical trial is conducted in a group of participants under controlled conditions to help us find the most effective therapies to treat different medical conditions.
What is a Placebo?
Answer: A placebo is a non-active treatment, which is made to look like the real medication. In this study the treatment medication is compared to the placebo.
What is the purpose of this study?
Answer: The primary objective of this study is to determine if Type 1 diabetes can be prevented. Study participants need to be at high risk of developing Type 1 diabetes but have no symptoms at present. In these people it may be possible that a nasal spray could prevent or delay the need for daily insulin injections.
Who is the sponsor for this trial?
Answer: Melbourne Health is the trial sponsor
Who is funding the trial?
Answer: The trial is being funded through the Diabetes Vaccine Development Centre (DVDC).
What is the name of the new treatment being used in the study?
Answer: It is intranasal insulin that is delivered via a nasal spray. The site will provide further information.
How is the treatment given?
Answer: Via a nasal spray.
Has it been tested before?
Answer: Yes, the intranasal insulin treatment has been tested previously in an earlier clinical study.
Did the study medication initially get tested on animals?
Answer: Yes, it is a legal requirement that every medication is tested on animals before it is approved for use in humans. There are very strict guidelines however to ensure that all animals involved in scientific testing are treated humanely.
How many people will participate in the study?
Answer: Approximately 16,500 people across Australia and New Zealand that have Type 1 diabetes in their families will participate with the initial blood test. However only approximately 2 percent (1 in 50 or 2 on 100) will actually be eligible to participate because these people will have the antibodies present in their blood, which indicate that they are at high risk of developing Type 1 diabetes.
Where is the study being conducted?
Answer: The study is being conducted at a number of major hospitals throughout Australia and New Zealand.
Who can participate?
Answer: Anyone aged between 4-30 years who has a family member diagnosed with Type 1 diabetes can potentially participate in this study: any relative of someone with Type 1 diabetes is urged to participate by having a simple blood test to determine if they have the antibodies present that indicate that they are also at high risk of developing Type 1 diabetes.
What will I have to do in the study?
Answer: If eligible, study participants will self-administer the insulin solution or placebo using a nasal spray every morning for one week (7 consecutive days) and then once a week for 12 months. They will then be followed up for a further four years with an appointment every 6 months.
Why do I have to have a blood test?
Answer: Study participants need to be at high risk of developing Type 1 diabetes but have no symptoms at present to be eligible. A simple blood test can measure the antibodies and determine whether or not they may be eligible.
How long is the study?
Answer: The treatment phase for the study is 1 year. After this, participants are then followed up for a further four years with an appointment every 6 months.
Will I be paid to participate?
Answer: No, you will not be paid for your participation in this trial.
Will it cost me anything?
Answer: There will be no charge to you for the consultations and examinations related to the study, including the blood test.
Will my travel costs be reimbursed?
Answer: Reasonable travel expenses to the study site will be reimbursed (e.g. taxi fare / reimbursement for using own car). Study participants travelling to the site will not incur expenses.
What are the possible benefits of the study?
Answer: There are several excellent reasons to encourage you or your children to participate:
If you are related to someone with Type 1 Diabetes you are in a unique position to contribute towards the future prevention of Type 1 Diabetes. Hopefully people will no longer have to use daily insulin injections to control the symptoms of Type 1 Diabetes.
If you’re at risk of Type 1 Diabetes then it is beneficial for you to check for the antibodies that may indicate that the disease has started. You can then decide to participate in the study or alternatively be aware of symptoms progressing.
What are the possible risks of the study?
Answer: As with all medications, there is a small possibility that you may experience side effects but they are usually very minor and transient. Your study doctor will be able to discuss this in more detail.
Will I be compensated if something goes wrong?
Answer: In the unlikely event that you suffer an injury as a result of participating in this research study, hospital care and treatment will be provided by the public health service at no extra cost to you. Your study doctor will explain this further to you.
What are the side effects and what if I get them?
Answer: As with all medications, there is a small possibility that you may experience side effects but they are usually minor and transient. Your study doctor will be able to discuss this in more detail.
Can I drop out at any time?
Answer: Yes, if you wish to stop taking part in the study, you may do so at any time. You are under no obligation to finish the study, but we hope you will. If you decide not to complete the study, your decision will not affect your future medical care in any way.
Why do you need all my personal details?
Answer: We only need to take details to help us establish if you may be eligible to take part in the study and to send you the consent form. If you meet the initial criteria with the result of the blood test, the appropriate research site can call you back to discuss the study in more detail and organise an initial visit.
When you send me information, does that mean I am taking part?
Answer: No, this is a pre-screening stage to establish if you may be eligible to take part in the study.
ONLY about two percent of people who have the blood test will have sufficiently high levels of antibodies that will enable them to be eligible to take the study treatment – this is why it is so critical to encourage as many family members as possible to have a simple blood test.
Can my mother, father, partner, friend take part?
Answer: If your mother, father, partner or friend is aged between 4 and 30 and has a relative with Type 1 diabetes, then they can participate in the study.
Why can't I take part?
Answer: The study has strict inclusion and exclusion criteria and you need to meet these criteria in order to take part. In order to participate it is essential that you have Type 1 diabetes in the family but do not have Type 1 diabetes yourself (unless it is your child that you are enquiring about). Your family member with Type 1 Diabetes needs to have been diagnosed before the age of 40. If your family member with Type 1 diabetes is your grandmother, grandfather, aunt, uncle, niece, nephew, half-sister or half-brother ie a second degree relative, you will need to be aged between 4-20 years old to participate.
If you’re concerned about your condition please contact your GP.
The Type 1 Diabetes Prevention Study
Register your interest
To establish your eligibility or learn more about the trial:
Register Online:
Type 1 Diabetes Prevention Trial (INIT II) Clinical Trial Registration Site
Download a copy of the Participant Information and Consent Form or arrange to have one mailed to you.
Signed consent forms should be sent to:
Intranasal Insulin Trial II
Reply Paid 84486
Darlinghurst NSW 2010
Enquire by Phone:
To speak with the Type 1 Diabetes Prevention Trial (INIT II) Call Centre:
1300 138 712
Further enquiries...
Please contact dvdc@dvdc.org.au for any further enquiries.
Please include your name and contact details in the email.
Links
You can also find the following sites via Google -
- Diabetes Australia - VIC
- Diabetes Australia - ACT
- Diabetes Australia - NSW
- Diabetes Australia - QLD
- Diabetes Australia - WA
- Diabetes Australia - SA
