Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A single arm study investigating the glycaemic control and safety of adding semaglutide to insulin icodec in participants with type 2 diabetes qualifying for treatment intensification.

This study is investigating a new treatment approach for adults in the UK with type 2 diabetes, especially for those whose current treatment isn't quite managing their blood sugar levels. Researchers are combining two medicines, semaglutide and insulin icodec, to see if this mix can offer better control. The main goal is to find out if this combination effectively lowers blood sugar (measured by HbA1c) and to understand how it impacts daily blood sugar readings after meals and overall. Importantly, the study also focuses on safety, looking closely at how often people might experience very low blood sugar. This is a crucial step in understanding if this new combination could be a useful option for managing type 2 diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novo Nordisk A/S

Enrolment target

Start

31 Aug 2023

Diabetes Type 2

What is this study about?

This study is an important step in finding better ways to manage type 2 diabetes. As you may know, type 2 diabetes means your body either doesn't produce enough insulin or doesn't use it properly, leading to high blood sugar levels. Over time, high blood sugar can cause health problems.

For some people, their usual treatments might not be enough to control their blood sugar. This study is testing if adding a medication called semaglutide to a new type of long-acting insulin, called insulin icodec, can help more effectively. Semaglutide is a medicine that helps your body release more insulin when needed and reduces the amount of sugar your liver makes. Insulin icodec is a newer insulin designed to be taken once a week, potentially making it easier to manage.

The main aim of the study is to see how much this combination lowers blood sugar levels. They will measure this with a blood test called HbA1c (which gives an average blood sugar over a few months), and also by looking at daily blood sugar readings. The study is also very focused on safety, particularly checking for side effects like very low blood sugar, which is called hypoglycaemia. By understanding both the benefits and potential risks, researchers hope to see if this treatment combination could become a good option for people living with type 2 diabetes.

Key takeaways

This study evaluates a new combination of medicines for type 2 diabetes.
It aims to improve blood sugar control for those whose current treatments aren't enough.
The study checks both how well the treatment works and its safety, especially regarding low blood sugar.
Participation involves regular clinic visits, blood tests, and taking study medications.
You'll receive close medical attention throughout the study.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with type 2 diabetes. Both men and women can take part.

You might be a good fit if your doctor feels your current diabetes treatment isn't fully controlling your blood sugar levels, and they believe adding new medication is the next step.

There will be other detailed health requirements specific to the study, so your doctor or the study team will check these carefully to make sure the study is right for you and safe for you to participate in.

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?
Does your doctor feel your blood sugar control could be better with additional treatment?
Are you comfortable attending regular clinic appointments?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to a clinic over a set period. During these visits, you'd likely have blood tests, including checks for your HbA1c levels and other blood sugar measurements. You would receive the study medications, semaglutide and insulin icodec, and be taught how to take them. The team would also monitor any changes in your body weight and how much insulin you need. You'd be asked to keep track of your blood sugar levels at home, usually at specific times during the day, and report any symptoms, especially those related to low blood sugar. The study team will provide all necessary equipment and explain everything clearly. They will also be there to support you and answer any questions throughout the study.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as receiving close medical attention and potentially accessing new treatments before they are widely available. The combination of medicines might improve your blood sugar control. However, all medications can have side effects. You might experience low blood sugar (hypoglycaemia), or other common side effects linked to these types of drugs, such as nausea or digestive issues. The study team will continuously monitor you for any side effects. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Poland
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Unverified
Czechia

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, leading to high blood sugar levels.

What is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the past 2 to 3 months. It's a key measure for diabetes control.

What does 'glycaemic control' mean?

Glycaemic control simply means how well your blood sugar levels are being managed and kept within a healthy range.

What is hypoglycaemia?

Hypoglycaemia is when your blood sugar level drops too low. It can make you feel shaky, sweaty, dizzy, or confused.

What are 'clinical trials'?

Clinical trials are research studies that test new medical treatments or ways of using existing ones, to see if they are safe and effective for people.