Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A 40-week study comparing the efficacy, safety and patient-reported outcomes of once weekly IcoSema and once or twice daily insulin degludec/insulin aspart 100 units/mL, both treatment arms with or without oral anti-diabetic drugs, in participants with type 2 diabetes inadequately controlled with daily pre-mixed insulin. COMBINE 5

If you have type 2 diabetes and your current pre-mixed insulin isn't keeping your blood sugar in check, this 40-week study might be of interest. It's comparing two different ways to manage your diabetes: a new once-weekly injection called IcoSema, and an existing daily or twice-daily insulin called Ryzodeg. The study wants to find out which of these treatments is better at controlling blood sugar (measured by something called HbA1c), how safe they are, and how they affect your quality of life and overall satisfaction with treatment. You might also be taking other diabetes medications during the study. This is a crucial step to understand more about these treatments and help people with type 2 diabetes live healthier lives.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novo Nordisk A/S

Enrolment target

Start

09 Dec 2025

Type 2 diabetes

What is this study about?

This research is looking for adults with type 2 diabetes whose blood sugar isn't well-managed, even though they're already taking daily pre-mixed insulin. The study aims to compare two different treatment approaches: one involves a once-weekly injection called IcoSema, and the other uses an existing insulin product called Ryzodeg, which is injected once or twice a day. Both groups might also be taking other diabetes medicines that come in pill form.

The main goal is to see how well each treatment helps to lower something called HbA1c, which is a blood test that shows your average blood sugar levels over the past few months. They will also be looking at other important things like how much you weigh, how many times people experience low blood sugar (hypoglycaemia), and how satisfied people are with their treatment and their overall quality of life.

This kind of study is called a 'Phase III' trial, which means it's a big step before a new treatment might become widely available. By carefully comparing these two treatments, researchers hope to find new and better ways to help people with type 2 diabetes manage their condition more effectively and safely.

Key takeaways

It's a 40-week study for adults with type 2 diabetes.
It compares a new once-weekly insulin (IcoSema) with an existing daily/twice-daily insulin (Ryzodeg).
The main goal is to see which treatment is better at controlling blood sugar.
Researchers also check for safety, side effects, and how patients feel about their treatment.
Participants may continue taking other diabetes tablets.

Who may be eligible?

This study is looking for adults aged 18 and over who have type 2 diabetes. Importantly, your diabetes should not be well-controlled with your current daily pre-mixed insulin treatment.

To be suitable for the study, you'll need to meet specific health criteria, which the study team will discuss with you. Both men and women can take part.

The research team will carry out a full assessment to make sure the study is a safe and appropriate option for you.

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?
Is your current daily pre-mixed insulin not keeping your blood sugar well-controlled?
Are you able to attend regular clinic visits for about 9-10 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will last for a period of 40 weeks, which is about 9-10 months. You will be given either the new once-weekly IcoSema injection or the existing daily/twice-daily Ryzodeg insulin to use, along with any other diabetes tablets you might already be taking.

You'll have regular visits to the clinic so the study team can monitor your health, check your blood sugar levels (including HbA1c), and see how you're responding to the treatment. They will also ask you questions about your overall health, how you're feeling, and your satisfaction with the treatment. You'll likely need to provide blood samples and have other routine health checks throughout the study period.

Potential risks and benefits

Taking part in this study might offer you access to new treatments and closer medical monitoring, which could lead to better management of your diabetes. However, like all medications, the treatments in this study could have side effects, and there's no guarantee that the treatment will work for you. You will be fully informed of all known potential risks before you decide to join. Remember, taking part is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Poland

Common questions

What is HbA1c?

HbA1c is a simple blood test that gives doctors an idea of your average blood sugar levels over the past 2-3 months.

What is 'hypoglycaemia'?

Hypoglycaemia, or a 'hypo', is when your blood sugar levels drop too low. It can make you feel shaky, sweaty, or dizzy.

Will I still take my other diabetes medicines?

Yes, some participants in the study will continue to take their oral (by mouth) diabetes medications alongside the study insulin.

How long will I be in the study?

The study treatment and monitoring period will last for 40 weeks, which is just over nine months.

What does 'Phase III' mean?

Phase III means it's a large study that compares new treatments with existing ones to confirm their benefits and safety before they can be widely used.