A Study to See the Effect of NNC0194-0499 Alone or in Combination With Semaglutide on Blood Sugar Control in People Living With Type 1 Diabetes
This study aims to understand how a new medicine, NNC0194-0499, works for people living with type 1 diabetes. We want to see if it helps control blood sugar levels, either by itself or when combined with another medicine called semaglutide. Everyone taking part will continue with their regular insulin treatment. The new medicine is still being tested, which means it hasn't been approved for widespread use yet. The study will last for about 36 weeks. We hope this research will help us find better ways to manage type 1 diabetes.
At a glance
What is this study about?
Imagine you have type 1 diabetes, and you're always trying to keep your blood sugar just right. This study is looking into a new medicine, currently called NNC0194-0499, that might help. Scientists want to see how this new medicine works, either on its own or when given with semaglutide, another treatment. All participants will keep using their usual insulin, which is still the main treatment for type 1 diabetes.
The main goal is to find out if NNC0194-0499 can positively affect blood sugar levels in people with type 1 diabetes. We need to do these studies to make sure new medicines are safe and actually work well. By understanding how this new medicine behaves, we can learn if it could become a helpful option for managing type 1 diabetes in the future.
This kind of research is very important because it helps improve treatments for long-term conditions like type 1 diabetes. Every new finding helps doctors and patients have more options and better ways to stay healthy. This particular study is in an early stage, which means we are carefully checking how the medicine works in people for the first time.
Key takeaways
- This study is testing a new medicine for type 1 diabetes.
- It aims to improve blood sugar control.
- Participants will continue their usual insulin treatment.
- The study lasts about 36 weeks.
- Careful monitoring and regular check-ups are part of the study.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be between 18 and 64 years old. You must have been diagnosed with type 1 diabetes at least a year ago and be using multiple daily insulin injections, with your insulin dose stable for over 90 days.
Your body mass index (BMI) needs to be between 22 and 35. You should also be generally healthy, apart from your type 1 diabetes, and your doctor will decide if you meet this. You must be using a Continuous Glucose Monitor (CGM) regularly for at least six months and be willing to use a CGM provided by the study, stopping your own during the study.
There are also some reasons why you might not be able to join. For example, if you've recently used certain diabetes medicines called GLP-1 RAs, or if you have certain heart conditions. The study team will review your full medical history to check if it's safe for you to participate.
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.
- Are you between 18 and 64 years old?
- Have you had type 1 diabetes for at least a year?
- Do you use multiple daily insulin injections and has your dose been stable for over 3 months?
- Do you regularly use a Continuous Glucose Monitor (CGM) for at least 6 months?
- Are you generally healthy, aside from your type 1 diabetes?
- Do you have a Body Mass Index (BMI) between 22 and 35?
What does participation involve?
If you decide to take part, the study will last for about 36 weeks, which is roughly 9 months. During this time, you will receive the study medicine, which could be NNC0194-0499, semaglutide in combination with NNC0194-0499, or a placebo (a dummy medicine with no active ingredients). This is decided randomly, like drawing lots.
You'll continue using your regular insulin as prescribed by your doctor. You'll need to attend regular appointments at the study clinic for check-ups, blood tests, and to make sure the medicine is working safely. You will also use a Continuous Glucose Monitor (CGM) provided by the study throughout the trial to help track your blood sugar levels.
The study team will explain everything in detail, including how often you'll need to visit and what each visit involves. There will be careful monitoring of your health and any effects of the medicines. After the treatment period, there will be follow-up appointments to ensure your health remains good.
Potential risks and benefits
Locations (1)
- Profil Institut für Stoffwechselforschung GmbHVerified postcodeNeuss, Germany
Common questions
What is NNC0194-0499?
It's a new medicine being tested to see if it can help control blood sugar in people with type 1 diabetes.
Will I stop taking my insulin if I join?
No, all participants will continue to take their regular insulin treatment throughout the study.
What is a 'placebo'?
A placebo is a dummy medicine that looks like the real treatment but contains no active ingredients. It helps researchers see if the real medicine is truly effective.
How long does the study last?
The study will last for about 36 weeks, which is roughly 9 months.
What kind of monitoring will there be?
You'll have regular clinic visits, blood tests, and will use a Continuous Glucose Monitor (CGM) provided by the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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