Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Investigating how CagriSema, semaglutide and cagrilintide regulate insulin effects in the body of people with type 2 diabetes.

This research study is for people living with type 2 diabetes. Its main goal is to understand how two experimental medicines, CagriSema, semaglutide, and cagrilintide, affect important body processes, especially those related to insulin and blood sugar. Insulin helps your body use sugar for energy, and in type 2 diabetes, this process doesn't work as well as it should. This is an early-stage study, which means researchers are carefully checking how these medicines work in humans for the first time. The findings from this study could help scientists develop better ways to manage type 2 diabetes in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novo Nordisk A/S

Enrolment target

150

Start

03 Apr 2024

Type 2 diabetes

What is this study about?

This research is focused on people who have type 2 diabetes. We want to understand more about how new medicines, called CagriSema, semaglutide, and cagrilintide, work in the body. Think of insulin as a key that unlocks your body's cells to let sugar in for energy. In type 2 diabetes, this 'key' doesn't work properly, or you don't have enough of it, leading to high blood sugar.

Researchers in this study are looking closely at how these new medicines might affect this process. They want to see if these medicines can help your body use insulin more effectively or help manage your blood sugar levels. This is a very early stage of research, so it's about learning the basic ways these medicines interact with the human body, rather than testing if they are a new treatment yet.

Understanding these basic effects is really important. The information gathered from studies like this helps scientists develop new and improved ways to help people with type 2 diabetes. It's a crucial step in discovering potential new treatments that could make a difference to people's health.

Key takeaways

This study is testing new medicines for type 2 diabetes.
It's an early-stage study to understand how medicines work in the body.
Participants must be 18 or older with type 2 diabetes.
The study aims to improve future diabetes treatments.
Participants will receive close medical monitoring.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, so people of all adult ages can take part. You also need to have been diagnosed with type 2 diabetes.

Anyone, whether male or female, can be part of this research. The study needs to include a variety of people to make sure the findings are useful for everyone affected by type 2 diabetes.

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 18 years old or older?
Have you been diagnosed with type 2 diabetes?
Are you able to attend regular clinic appointments?
Are you comfortable with receiving experimental medication?
Are you generally in good health other than your diabetes condition?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be one of the first people to take these new medicines, CagriSema, semaglutide, or cagrilintide. This type of early study often involves several visits to a clinic over a period of time. During these visits, the research team will do various checks, like measuring your blood sugar, taking blood samples, and checking your general health.

You will receive the study medicine, likely as an injection, and the research team will carefully monitor how your body reacts to it. There will be regular follow-up appointments to ensure your safety and to gather important information about the medicine's effects. The total time you'd spend in the study will be explained in full by the research team.

Potential risks and benefits

Taking part in a research study has potential benefits and potential risks. A possible benefit is that you would be contributing to scientific understanding that could lead to new treatments for type 2 diabetes in the future. You will also receive close medical attention from the study team. However, because these are new medicines, there might be side effects that are not yet fully known. There is also no guarantee that the medicine will help your diabetes. You will be told about all known risks before you agree to participate, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Germany

Common questions

What does 'Phase I' mean?

It means this is a very early study. Researchers are carefully checking how the medicines work and if they are safe in a small number of people, rather than whether they are effective as a treatment yet.

Are CagriSema, semaglutide, and cagrilintide already available medicines?

No, these are experimental medicines being studied. They are not yet approved for general use.

Will this study cure my type 2 diabetes?

No, this study is not designed to cure diabetes. Its purpose is to understand how these new medicines work in the body.

Will I have to pay to join the study?

Research studies generally cover the costs related to the study medicine and visits. Any expenses you might incur will be fully explained.

How long will I be in the study for?

The exact length of time will be explained by the study team, but early-stage studies often involve multiple visits over several weeks or months.