Diabetes Research Centre

Towards the prevention and cure of diabetes

WEHI

Diabetes Research Centre

Melbourne, Australia

Diabetes Research at the Walter + Eliza Hall Institute of Medical Research and the Royal Melbourne Hospital

RMH

 

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Clinical Trials

 

Click on one of the links below to view information on individual trials, or click on the star to see an overview of all trials currently being conducted by this Centre.

This area was last updated on May 29, 2009

Ongoing Trials

Completed Trials

 

INIT II (Intranasal Insulin) Trial

    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”).

    The INIT II trial is now recruiting in Australia and New Zealand! Visit the INIT II website at www.stopdiabetes.com.au/

    Read more about INIT II

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TrialNet Natural History Study

Type 1 diabetes is a life-long condition that can affect both children and adults. It occurs when the body attacks and destroys the cells in the pancreas that make insulin. The body needs insulin, a hormone, to turn food into energy. The goal of this study is to increase our understanding of how type 1 diabetes develops over time. Better understanding may help to prevent diabetes or develop a cure.

Read more about the TrialNet Natural History Study

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Lap-Band surgery versus lifestyle in type 2 diabetes

We know that diabetes improves dramatically when obese people lose around 20 kilos. Afterwards, most have normal blood sugar levels despite stopping medication. A recent study in people who were obese showed huge improvements for those with diabetes who had a lap band. We are trying to find out if lap banding is better than lifestyle approaches for people newly diagnosed with type 2 diabetes who are overweight.

Read more about Lap-Band surgery versus lifestyle in type 2 diabetes

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Vitamin D and Autoimmune Adult-Onset Diabetes

Vitamin D is a steroid hormone with anti-inflammatory properties. People with lower levels of vitamin D may be more susceptible to inflammatory diseases such as type 1 diabetes. The aim of this study is to determine whether vitamin D repletion will slow the progression of adult-onset autoimmune diabetes, possibly obviating the need for insulin injections.

*** This study is no longer recruiting ***

Read more about the Vitamin D study

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Type 1 Diabetes Genetics Consortium

    The Type 1 Diabetes Genetics Consortium is a group of diabetes researchers from around the world who have come together to collect samples and information from families with Type 1 diabetes.

    We are trying to discover how differences in the genes that we inherit from our parents contribute to the risk for development of Type 1 diabetes. Genes are the “blue prints” in our bodies that we get from our parents at birth. Genes decide our characteristics like the color of our hair, our eyes and the shape of our bodies. Some genes are also involved in whether you have diabetes or not. If we find out more about these genes, we may be able to prevent diabetes in the future.

    *** This study is no longer recruiting ***

    Read more about the Type 1 Diabetes Genetics Consortium

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Completed Trials

INIT III (LADA) Trial

    Up to one in ten adults with presumed type 2 diabetes have features of both forms of diabetes, ie 'type 1.5 diabetes', and they are at higher risk of rapidly progressing to insulin injection treatment, often within several years after diagnosis. Adults with type 1.5 diabetes have insulin resistance, but are also found to have antibodies responsible for beta-cell destruction. The presence of these antibodies gives type 1.5 diabetes its other name, 'latent autoimmune diabetes in adults' (LADA).

    The INIT III trial is a clinical trial involving an immune therapy in the form of insulin given as a nasal spray to determine whether it can delay or prevent the need for insulin injections.

    Read more about the INIT III Trial

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TrialNet MMTT-GST Research Study

When we conduct clinical research in people with type 1 diabetes, it is important for us to know how much insulin is still being produced by the pancreas. Currently, two tests, a Mixed Meal Tolerance Test (MMTT) and a Glucagon Stimulation Test (GST) have been used to measure insulin production. The aim of this study is to compare these two tests to find out which is a better measure of insulin secretion, and which test people tolerate better.

This test will help us develop a standardised way to test for insulin production in pre-clinical and clinical type 1 diabetes. A standardised test of this kind will be invaluable both for planning intervention and prevention studies in type 1 diabetes and for measureing their outcome.

Read more about the MMTT-GST Research Study

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Australian BabyDiab Study

As you may know, type 1 diabetes (also known as insulin-dependent or juvenile diabetes) is known to run in families. If a child's mother, father, brother or sister have insulin dependent diabetes, his or her risk of developing diabetes in increased. In studies of families in which one or more members have diabetes we have found it is possible to use a blood test for antibodies to the pancreas (called islet autoantibodies) to identify other family members at risk for diabetes. There is evidence that these antibodies to the pancreas develop within the first six years of life.

This study will identify those at increased risk for type 1 diabetes and observe them over time. It will also aid in the recruitment and assessment of those who might qualify for future diabetes prevention trials. Eligible participants would be offered participation in prevention trials as these become available.

Read more about the Australian BabyDiab Study

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INIT I Trial

The ability to use self-antigens as tools to induce protective immunity, free from the side-effects of conventional non-specific immunosuppressive agents, is the 'Holy Grail' of autoimmune disease therapy. Administration via 'tolerogenic' mucosal routes in animal models has provided proof-of-concept for such antigen-specific therapy. For example, we have shown that regulatory T cells that prevent diabetes can be induced by administering insulin to the naso-respiratory tract of diabetes-prone mice.

On this background, we conducted a trial of intranasal insulin in 38 humans (median age 10.8 years) at risk for type 1 diabetes to determine the effect of intranasal insulin on immune and metabolic markers and to ensure that this potentially immunoprotective strategy was safe. The intranasal insulin trial (INIT) was randomized, placebo-controlled and double-masked, with a crossover at six months. A separate cohort of 13 subjects (median age 13.0 years), was followed to symptomatic diabetes over 1.0-7.7 years up to the time the trial commenced.

Read more about the INIT I Trial

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Diabetes Research Centre

Last updated 7 August 2009. For further information about this website, please contact Catherine McLean