Extrait

Background and study aims Type 1 diabetes (insulin-dependent diabetes) is caused by the body's own white blood cells damaging the insulin producing cells in the pancreas. Our aim is to develop a treatment that can slow or stop this process by switching off the white blood cells causing the damage. At present we are at quite an early stage in this research. In a previous study we were able to show in people who had had diabetes a long time that giving 3 injections of a small part of one of the molecules in the beta cells, proinsulin, appeared safe and may begin to switch off the white blood cells that are causing the damage. In this study, we are looking to see if this is also true in people who have newly-diagnosed diabetes. We will also be testing whether giving more than three injections is more effective, and whether this treatment can slow or stop the loss of insulin from the pancreas in the year after people are diagnosed. Who can participate? To take part you need to be aged 18-40, diagnosed with type 1 diabetes and have received your first insulin injection within 100 days of entering the trial. What does the study involve? If you take part, first of all, you will be asked to give a small sample of blood to test your tissue type and the antibodies to the pancreas in your blood. This sample will be taken in the same way as any standard blood test. Only around one half of people with type 1 diabetes have the right tissue type to respond to the particular fragment of proinsulin we are testing. If the first test shows you have antibodies to the pancreas and the right tissue type for the study, you will be asked to come to your local research centre for a general examination and further blood tests including a test of the amount of insulin your body still makes in the 2 hours after a standard liquid meal. If you still have some insulin response after the meal (80-90% of people do within the first year after diagnosis) you will be contacted by the research team to arrange the first injection treatment of the study. The treatments involve a very tiny, almost painless injection under the skin of the arm given in a very similar way to vaccination injections. Everyone in the trial will receive injections every 2 weeks for 24 weeks and then check-ups for another 24 weeks. People in the trial will be in one of three groups. Group A will receive only salt water injections (placebo). Group B will receive peptide injections every 4 weeks with saline injections in between. Group C will receive peptide injections every 2 weeks. Neither you nor the person giving you the injections will know until the end of the study which group you are in and which injections you are receiving. Also no one can chose which group you go into: this is done randomly by a computer programme so that everyone has an equal chance of being in any particular group. During the treatment, you will be asked to provide blood samples to test the response of your body's immune system and to pick up any side effects and on 3 occasions we will do the mixed meal tolerance test again to see how much insulin your body is making. The amounts of blood taken will be larger than usual to allow special laboratory tests to be performed. At the end of this test we will ask you for a urine sample to send to the research lab. You will not be told the results of the tests until the end of the trial unless any of the results are not normal and need treatment. The total blood volume taken from you whilst you are on the trial will be within the guidelines of the National Institute of Health, USA. Every 2 weeks you will be contacted by a nurse or doctor with training in diabetes to discuss your insulin treatment and blood sugar levels and help make sure your insulin treatment is keeping your sugar levels in a good range. What are the possible benefits and risks of participating? During the research project your diabetes will be very closely monitored, you will receive regular input from a nurse to help with your diabetes as well as regular check-ups including routine blood testing. If you are in the group that receives the 'active' peptide injection, it is possible that it will help keep your pancreas making insulin for longer but we cannot say this for certain until we have completed this and further research studies. There may be bruising and discomfort at the site of the blood test as with any blood test. The amounts of blood we are taking are small enough that they should not make you feel fatigue or cause anaemia. There may be local red reactions at the site of the injections. It is possible that you might have a severe reaction to the injection requiring treatment. However, we have not seen any severe reactions in the 37 people who have received this injection so far. All injections will be given with trained staff and equipment on hand if you should have any problems. If you do have a severe reaction, no further injections will be given. It is theoretically possible that if you are in the group that receives injections of 'active' peptide that they might weaken the insulin production from your pancreas. This has not been seen in previous studies and we will be testing you for insulin production every 12 weeks. Where is the study run from? It is being organised by Cardiff University and King's College London. There are four hospitals participating: 1. University Hospital of Wales, Cardiff 2. Guys Hospital, London 3. Bristol Royal Infirmary, Bristol 4. Royal Victoria Infirmary, Newcastle. When is the study starting and how long is it expected to run for? From July 2011 to February 2015. Who is funding the study? This study is being funded by the Diabetes Vaccine Development Centre in collaboration with the Juvenile Diabetes Research Foundation International. Who is the main contact? Rachel Stenson [email protected]

Critère d'inclusion

• Newly diagnosed type 1 diabetes

Liens

• isrctn
• ictrp