Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Safety and efficacy of once-weekly subcutaneous and once-daily oral NNC0487-0111 in participants with type 2 diabetes – a dose finding study

This research is a Phase II study investigating a new medicine called NNC0487-0111 for individuals living with type 2 diabetes. The main goal is to find the right dose and see how safe and effective this new treatment is when given either as a once-weekly injection under the skin or as a once-daily tablet. Researchers will primarily be checking how well it helps manage blood sugar levels (measured by HbA1c). They will also look at other important health markers like body weight, blood pressure, and cholesterol. Some participants will receive a placebo (a dummy medicine) to compare the effects of the new treatment. This will help doctors understand if NNC0487-0111 could be a helpful new option for managing type 2 diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Novo Nordisk A/S

Enrolment target

339

Start

11 Jul 2024

Type 2 Diabetes

What is this study about?

This study is a Phase II clinical trial, which means it's an early stage of research to see if a new medicine works and is safe. The medicine being tested is called NNC0487-0111, and it's for people who have type 2 diabetes. The main purpose of this study is to look at different ways to give this medicine – some people will get it as a shot under the skin once a week, and others will take a pill once a day. The researchers want to find the best dose and method of delivery.

The main thing the doctors will be measuring is how well the medicine helps control blood sugar levels over time. This is often checked with a test called HbA1c. They will also be looking at how the medicine affects other important health factors for people with type 2 diabetes, such as body weight, blood pressure, and cholesterol levels. They'll also check for any side effects to understand the safety of the new medicine.

By comparing the new medicine to a placebo (a treatment with no active medicine) and sometimes to existing diabetes medicines like metformin or dapagliflozin, the researchers hope to understand if NNC0487-0111 could be a valuable new option for managing type 2 diabetes. This study is crucial for learning more about this potential new treatment and bringing new possibilities to people living with this condition.

Key takeaways

This study is testing a new medicine (NNC0487-0111) for type 2 diabetes.
It aims to find the best dose for once-weekly injections or once-daily pills.
Researchers will check its effect on blood sugar (HbA1c), weight, blood pressure, and more.
Some participants will receive a placebo for comparison.
It's a Phase II study, looking at safety and how well the treatment works.

Who may be eligible?

To join this study, you need to be at least 18 years old. There's no upper age limit, so adults of many ages can take part.

Both men and women are welcome to participate in this research. The study aims to include a wide range of people to understand how the new medicine works in different individuals.

The research team will have specific medical criteria to make sure the study is right for you and that taking part is safe. This will include details about your type 2 diabetes and any other health conditions you might have. You'll discuss all these details with the study doctor to see if you're a good fit.

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?
Do you have type 2 diabetes?
Are you able to attend regular clinic visits?
Are you willing to potentially receive an injection or take a daily pill?
Are you comfortable with the possibility of receiving a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll have regular visits to the clinic over a period of time. During these visits, the research team will perform various health checks, such as blood tests (including HbA1c, cholesterol, and kidney function), measure your weight, blood pressure, and waist size. You might also wear a continuous glucose monitor (CGM) to track your blood sugar throughout the day.

You will be given either the new medicine (NNC0487-0111) as a weekly injection or a daily pill, or a placebo (a dummy medicine), or in some cases, your existing diabetes medication will be used for comparison. The study is designed to compare these different treatments. You will receive clear instructions on how to take your assigned medication.

Throughout the study, the research team will keep a close eye on your health and any side effects you might experience. They will be there to answer your questions and support you. The total duration of your participation, including the number of visits and follow-up, will be fully explained to you before you commit.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical monitoring. However, there are also potential risks, including side effects from the study medicine, or that the treatment might not work for you. Some people may also experience discomfort from blood tests or other procedures. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

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

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Unverified
Romania
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Unverified
Spain
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Unverified
Poland
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Unverified
Slovakia
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Unverified
Hungary
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Unverified
Croatia
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Unverified
Germany
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Unverified
Bulgaria
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Unverified
Greece

Common questions

What is HbA1c and why is it important?

HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months. It's important because it gives a good overall picture of how well your diabetes is being managed.

What does 'Phase II' mean for a clinical trial?

Phase II means this is an early stage of research. The main goals are to see if the new medicine works, to find the best dose, and to check for any side effects before it can be tested in larger groups of people.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real treatment but contains no active ingredients. It's used to compare against the new medicine to see if the real medicine has a true effect.

Will I know if I'm getting the new medicine or the placebo?

In many studies like this, you won't know if you're receiving the active medicine or the placebo. This helps ensure the results are unbiased. The research team will explain how this works in more detail.

What if I have side effects during the study?

The research team will carefully monitor you for any side effects. If you experience anything unusual, it's very important to tell them right away so they can provide support and adjust your care if needed.