Extrait

Background and study aims Lixisenatide has been developed as an drug for diabetes and has been shown to improve blood sugar control in people with type 2 diabetes. This study aims to find out whether a daily injection of lixisenatide, along with prescribed insulin treatment, can improve blood sugar control in people with type 1 diabetes. The study will also find out if there is a difference between participants who have low insulin production from the pancreas and those who do not have insulin production from the pancreas. Part A of this study aims to find out a safe dose of insulin when given with lixisenatide, so that the participants do not experience a higher than normal frequency of low blood sugar events. The Part B is aiming to see whether there is an effect on blood sugar levels, especially after meals, when a daily injection of lixisenatide is added to a participant’s usual insulin treatment. Who can participate? People aged 18-70 years who have had type 1 diabetes for at least 12 months and use insulin injections to control their disease can take part. What does the study involve? The Part A study will last about 8 days for each participant and will involve a maximum of 7 Churchill Hospital visits and 5 telephone calls from our research team. Each participant will receive lixisenatide daily for up to 4 days alongside their usual insulin medication. The Part B study will last about 16 weeks for each participant and will involve a maximum of 13 Churchill hospital visits and 6 telephone calls from our research team. There will be two different treatment periods each lasting for 4 weeks with an additional 4 weeks in between when each participant will take insulin alone (the ‘washout’ period). Participants will receive lixisenatide for 4 weeks and a matching ‘dummy’ or placebo drug for the other 4 weeks. Neither the study team nor the participants will know which is which. What are the possible benefits and risks of participating? There are no direct benefits to the participant for taking part in this exploratory study. However, the results may help researchers find the correct dose for the meal-time insulin when used with lixisenatide for the next part of the study. This study may lead to future large-scale studies and lixisenatide may become an additional treatment for patients with type 1 diabetes. Reported side effects of lixisenatide include nausea and vomiting, loss of appetite and weight loss. Most side effects settle within days of starting the medication. When lixisenatide is used with insulin there may be a small risk of low blood sugar. The participant’s insulin dose will be reduced while they take the study drug to minimise this risk. The dose used in the daily injection is the same as used in type 2 diabetes. The participant’s health will be monitored closely during the study and the study medication would be stopped should there be any cause for concern. Where is the study run from? Churchill Hospital, Oxford, UK. When is the study starting and how long is it expected to run for? May 2014 to June 2016 Who is funding the study? Sanofi Aventis (UK). Who is the main contact? Dr Chitrabhanu Ballav (Principal Investigator)

Critère d'inclusion

• Topic: Diabetes; Subtopic: Type 1 ; Disease: Diabetic Control

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