Investigating How NNC0487-0111 Regulates Insulin of Adults With Type 2 Diabetes
This study is investigating a new medicine called NNC0487-0111, for adults living with Type 2 diabetes. The main goal is to understand how this potential new treatment affects how your body uses insulin – the hormone that helps manage your blood sugar levels. Researchers also want to see how it impacts the work of your pancreas, the organ that produces insulin. Some participants will receive NNC0487-0111, while others will get a placebo, which looks the same but contains no active medicine. The choice of treatment is made by chance. This is an early stage study, designed to assess the medicine's effects in a small group of people.
At a glance
What is this study about?
This research study is looking into a new medicine, called NNC0487-0111, for people who have Type 2 diabetes. Diabetes is a condition where your body struggles to use insulin properly, or doesn't make enough of it, leading to high blood sugar levels. Insulin is a really important hormone that helps sugar get from your blood into your cells to be used for energy.
The main purpose of this study is to find out exactly how NNC0487-0111 affects how your body uses insulin and how well your pancreas, the organ that makes insulin, is working. By understanding this, doctors hope to learn more about how this new medicine could help manage blood sugar in people with Type 2 diabetes.
This is an early stage study, meaning it's one of the first times this medicine is being tested in people. Early studies help researchers learn important information about new medicines, such as how they work and if they are safe, before they can be tested in larger groups.
Key takeaways
- This study is testing a new medicine (NNC0487-0111) for Type 2 diabetes.
- It aims to understand how the medicine affects insulin and pancreas function.
- You might receive the new medicine or a 'dummy' treatment (placebo).
- Your health will be closely monitored by a specialist team.
- You can stop participating in the study at any time if you wish.
- This is an early-stage study to gather important information.
Who may be eligible?
To join this study, you need to be an adult between 18 and 75 years old and have been diagnosed with Type 2 diabetes for at least 6 months. You should be taking metformin at a stable dose, or metformin alongside another diabetes medicine called an SGLT2i, and these doses should have been consistent for at least three months.
Your blood sugar control, measured by a test called HbA1c, needs to be within a specific range. For example, if you're only on metformin, your HbA1c should be between 6.5% and 9.5%. If you're on metformin with an SGLT2i, it should be between 6.0% and 9.0%.
You cannot join if you are pregnant, breastfeeding, or planning to become pregnant without using effective contraception. You also can't participate if you have Type 1 diabetes, have had significant weight changes or been on a strict diet recently, or have certain eye conditions related to diabetes that have needed recent treatment or are expected to need it soon. Taking certain other diabetes medicines or weight management drugs also means you can't take part.
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 75 years old?
- Have you had Type 2 diabetes for at least 6 months?
- Are you currently taking metformin, or metformin with an SGLT2i, at a stable dose for at least 3 months?
- Are you not pregnant, breastfeeding, or planning to get pregnant without effective contraception?
- Do you not have Type 1 diabetes?
- Have you not had recent significant weight changes (5% or more in 3 months) or been on a strict diet?
What does participation involve?
This study involves receiving either the new medicine, NNC0487-0111, or a placebo, which looks identical but has no active ingredients. You won't know which one you're getting, as this is decided randomly, like flipping a coin. This helps ensure the results are fair and unbiased. The study will involve regular visits to the clinic where you'll have various tests, such as blood samples, to see how your body is responding to the treatment. The overall duration of the study, including the number of visits and follow-up, will be fully explained by the study team if you are suitable to take part.
Potential risks and benefits
Locations (1)
- Profil Institut für Stoffwechselforschung GmbHVerified postcodeNeuss, Germany· Recruiting
Common questions
What is Type 2 diabetes?
Type 2 diabetes is a condition where your body struggles to use insulin properly or doesn't make enough of it, leading to high blood sugar levels.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used in studies to compare against the new medicine.
Will I know if I'm getting the new medicine or the placebo?
No, you won't know directly. This is decided by chance to ensure the study results are fair and accurate.
How long will I be in the study?
The full length of the study, including visits and follow-up, will be clearly explained if you are a suitable participant.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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