Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to test how insulin NNC0471-0119 works in the body in participants with type 2 diabetes when given by an insulin pump.

Researchers are conducting an early-stage study to learn more about a new insulin called NNC0471-0119. This study specifically involves individuals living with type 2 diabetes. The main goal is to understand how this new insulin behaves and is processed within the body when it's delivered using an insulin pump. This type of research is an important first step in developing new treatments. It helps scientists gather essential information about how the new insulin affects people, which is crucial before it can be studied in larger groups. Participants will be carefully monitored to see how their bodies react to the insulin and to ensure their safety throughout the study.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novo Nordisk A/S

Enrolment target

Start

23 May 2025

Diabetes mellitus type 2

What is this study about?

This study is about a new type of insulin, which has a scientific name: NNC0471-0119. If you have type 2 diabetes, your body either doesn't make enough insulin or doesn't use the insulin it makes very well. Insulin is a hormone that helps your body use sugar for energy. People with type 2 diabetes often need to take extra insulin to manage their blood sugar levels.

In this study, researchers want to see how this new insulin works inside the body when it's given using an insulin pump. An insulin pump is a small device that delivers insulin continuously through a tiny tube placed under the skin. This study is in its very early stages, sometimes called a Phase I study. This means it's one of the first times this new insulin is being tested in people. The main aim is to understand how the body handles the insulin, how much of it gets into the blood, and how long it stays there.

The information gathered from this study is really important. It helps scientists decide if this new insulin is promising enough to be tested in more people and in further studies. This could eventually lead to new and better ways to manage type 2 diabetes in the future.

Key takeaways

It's an early-stage study (Phase I) for a new insulin.
The study is for adults with type 2 diabetes.
It aims to understand how a new insulin works with a pump.
Both men and women can participate.
It's a step towards potentially new diabetes treatments.
Safety and how the body handles the insulin are key focus areas.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning people of any adult age can potentially join.

Both men and women are welcome to take part in this research. The study does not exclude anyone based on their gender.

Crucially, you must have type 2 diabetes to be considered for this study. The researchers will have other specific health requirements, for example, about certain aspects of your diabetes and overall health, to make sure the study is safe and appropriate for you. A medical team will check all these details carefully if you are interested.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of type 2 diabetes?
Are you able to attend study visits regularly?
Are you generally in good health, apart from your diabetes (as assessed by the study doctor)?
Are you comfortable potentially using an insulin pump if you don't already?

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

What does participation involve?

Taking part in this study would involve a series of visits to a clinic or research centre. During these visits, you would receive the new insulin (NNC0471-0119) through an insulin pump. The medical team would closely monitor your health, take blood and urine samples, and record how your body reacts to the insulin. You would also have regular health checks and discussions about your well-being. The total duration of your participation, including any follow-up appointments, would be explained in detail before you decide to join.

Potential risks and benefits

Potential benefits of taking part could include contributing to medical science and helping to develop new treatments for type 2 diabetes, which might benefit many people in the future. You would also receive careful medical monitoring throughout the study. However, there might be potential risks, such as side effects from the new insulin, discomfort from blood tests or the insulin pump, or inconvenience from clinic visits. 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 an insulin pump?

An insulin pump is a small device that delivers insulin continuously through a thin tube placed under your skin, helping to keep blood sugar levels stable.

Why is this study only for people with type 2 diabetes?

This study specifically focuses on how this new insulin works in individuals whose bodies have type 2 diabetes, which is different from type 1 diabetes.

Will I get paid to participate?

The study information available does not specify payment, but compensation for time and travel is common in clinical trials and would be discussed by the research team.

What is 'Phase I' of a clinical trial?

Phase I is an early stage where a new medicine is tested in a small group of people for the first time to check its safety and how it works in the body.

Will this new insulin definitely be available for everyone soon?

No, this is an early study. Many more studies are needed, and there's no guarantee the insulin will be approved for general use. This study is just one step in that process.