The effect of lixisenatide in type 1 diabetes
Managing blood sugar levels in type 1 diabetes can be challenging, especially after eating. This clinical trial looks at whether a medication called lixisenatide can help. Lixisenatide is already approved for type 2 diabetes to help smooth out blood sugar rises, but researchers want to see if it works for type 1 diabetes as well. The study is split into two stages. The first stage tests how to safely lower mealtime insulin doses to prevent low blood sugar episodes while using the new medicine. The second stage compares lixisenatide against a dummy injection (a placebo) over several weeks to see how it affects blood sugar after meals. The trial is based at the Churchill Hospital in Oxford and is open to adults aged 18 to 70 who have lived with type 1 diabetes for at least a year.
At a glance
What is this study about?
Type 1 diabetes is a lifelong condition where the body cannot make its own insulin. People living with the condition rely on regular insulin injections to keep their blood sugar levels within a healthy range. Even with modern insulin, blood sugar can spike quickly after meals, making day-to-day control tricky.
Lixisenatide is a medicine currently prescribed to people with type 2 diabetes. It works by slowing down how quickly food leaves the stomach and helping the body manage blood sugar spikes after eating. This trial aims to find out if adding a daily injection of lixisenatide to regular insulin treatment can give people with type 1 diabetes better control over their glucose levels.
Researchers also want to learn if the medicine works differently depending on how much natural insulin a person still makes. Many people with type 1 diabetes produce no insulin at all, while others still produce tiny amounts. By testing both groups, doctors hope to discover whether lixisenatide could become a helpful add-on therapy in the future.
Key takeaways
- Tests whether the type 2 diabetes drug lixisenatide helps blood sugar control in type 1 diabetes.
- Aimed at adults aged 18 to 70 who use a basal-bolus insulin routine.
- Split into a short dose-safety stage and a longer stage comparing the drug to a placebo.
- Requires regular clinic visits and phone check-ins at the Churchill Hospital in Oxford.
- Insulin doses will be carefully reduced and monitored to keep your blood sugar safe.
Who may be eligible?
You may be able to join this trial if you are between 18 and 70 years old and have had type 1 diabetes for at least one year. You should be using a standard basal-bolus insulin routine, which means taking long-acting background insulin along with fast-acting insulin at meal times.
Your blood sugar control, measured by an HbA1c test, should be between 7.0% and 10.0%, and your insulin doses need to have been fairly stable over the past three months. You also need to have a body mass index (BMI) under 35. Blood tests will check whether your body still produces trace amounts of insulin.
You will not be able to take part if you have type 2 diabetes or a genetic form of diabetes such as MODY. The research team will review your full medical history to ensure taking part is safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged between 18 and 70 years old.
- I have had type 1 diabetes for at least 12 months.
- I take background insulin plus mealtime insulin injections.
- My recent HbA1c level is between 7.0% and 10.0%.
- My insulin dose has been fairly steady for the last 3 months.
- I am able to travel to the Churchill Hospital in Oxford for visits.
What does participation involve?
Taking part involves visiting the Churchill Hospital in Oxford and having regular telephone check-ins. In Part A, you take lixisenatide for up to 4 days alongside your usual insulin to help doctors find a safe insulin dose. This part lasts about 8 days and involves up to 7 hospital visits and 5 phone calls.
Part B lasts around 16 weeks and involves up to 13 hospital visits and 6 phone calls. During this stage, you will receive lixisenatide daily for 4 weeks and a dummy injection (placebo) for 4 weeks, with a 4-week break in between where you only take your normal insulin. Neither you nor the doctors will know which injection you are receiving during each period. Throughout the trial, you will have blood tests and close health checks to monitor your blood sugar.
Potential risks and benefits
Locations (1)
- Churchill HospitalApproximateOxford, England
Common questions
Will I have to stop taking my usual insulin?
No. You will continue taking your normal insulin, though your doctor will reduce the dose slightly to lower the risk of low blood sugar.
What is a placebo?
A placebo is a dummy treatment designed to look just like the study medicine but containing no active drug. It helps researchers prove whether the real medicine actually works.
How is the study medicine taken?
Lixisenatide is given as a small injection under the skin once a day, similar to an insulin injection.
Where does the trial take place?
All study visits take place at the Churchill Hospital in Oxford, UK.
Can I leave the study early if I feel unwell?
Yes. You can withdraw from the study at any point, for any reason, without it affecting your standard medical care.
How to find out more
Irene Kennedy
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.