Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to test how insulin NNC0471-0119 H works in the body in participants with type 1 diabetes when given by an insulin pump.

This research is investigating a new insulin called NNC0471-0119 H. It's designed for adults with type 1 diabetes who use an insulin pump. The main goal of the study is to find out how this new insulin behaves once it's in the body. This includes understanding how quickly it starts working, how long its effects last, and how the body processes it. This type of study, often called an early-stage or 'Phase 1' study, is crucial for gathering basic information about new medicines. It helps scientists decide if the new insulin is promising enough to be tested in larger groups of people later on. Participants will receive the new insulin through their pump, and doctors will carefully monitor their bodies' responses.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novo Nordisk A/S

Enrolment target

Start

27 Nov 2024

Diabetes mellitus type 1

What is this study about?

This study is focused on a new insulin called NNC0471-0119 H, specifically for adults who have type 1 diabetes and use an insulin pump. When researchers develop new medications, they go through different stages of testing. This particular study is an early-stage one, sometimes called a 'Phase 1' study. At this point, the main aim isn't to see if the new insulin is better than existing ones, but rather to understand the basics of how it works in the human body.

Think of it like learning about a new car engine for the first time. You'd want to know how much fuel it uses, how fast it can go, and how it handles different conditions. Similarly, with this new insulin, doctors want to understand things like how effectively the body absorbs it, how long it stays active, and how the body breaks it down. This information is really important because it helps scientists figure out the right doses and whether the insulin is safe enough to study in more detail later on.

The findings from this study will be a stepping stone. If this new insulin shows promising results in this early stage, it could then move on to larger studies involving more people. Ultimately, the goal of such research is to hopefully develop better ways to manage type 1 diabetes in the future, providing more options for people living with the condition.

Key takeaways

This study is testing a new insulin (NNC0471-0119 H) for type 1 diabetes.
It's for adults (18+) who use an insulin pump.
The main goal is to understand how the new insulin works in the body.
This is an early-stage study (Phase 1) focused on safety and how the body handles the insulin.
Participation involves regular clinic visits and monitoring.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older, with type 1 diabetes. Both men and women can take part.

There might be other health requirements or medications you can or cannot be taking that would affect if you can participate. The study team will need to check your medical history to make sure the study is a good fit for you.

It's important to discuss the study with your doctor to understand all the requirements and confirm if you are eligible.

Quick self-check

Are you 18 years old or older?
Do you have type 1 diabetes?
Do you currently use an insulin pump?
Are you able to attend regular clinic visits?
Are you generally in good health apart from your diabetes?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you would receive the new insulin, NNC0471-0119 H, through your regular insulin pump. The researchers would need to closely monitor your body's response, which might involve regular blood tests to check your blood sugar levels and how the insulin is working. You would likely have several visits to the study clinic, where doctors and nurses would perform various assessments. These could include physical exams and other tests to keep track of your health. The total time you would be involved in the study, including all visits and any follow-up, would be explained in detail by the study team before you make any decisions.

Potential risks and benefits

Participating in a study like this could potentially offer benefits, such as gaining early access to a new experimental insulin that might eventually prove helpful for managing type 1 diabetes. However, like all medications, new insulins can have side effects that aren't yet fully known, and there might be risks involved in taking an experimental treatment. It's crucial to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Germany

Common questions

What is 'Phase 1' in a clinical trial?

Phase 1 is an early stage of testing a new medicine. It's mainly about understanding how the medicine works in the body and if it's safe, rather than how effective it is.

Will I stop my current insulin if I join?

The study involves using a new insulin with your pump. The study team will explain how this fits with your current diabetes management.

How long will the study last for me?

The total duration of your participation, including all visits and follow-up, will be clearly explained by the study team before you enroll.

What kind of tests will I have?

You'll likely have blood tests to check your blood sugar and how the new insulin is working, along with other health checks.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and it will not affect your usual medical care.