Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A 40-week study comparing the efficacy and safety of once weekly IcoSema and daily insulin glargine 100 units/mL in participants with type 2 diabetes inadequately controlled on oral anti diabetic drugs. COMBINE 4

This 40-week study, called COMBINE 4, is for people with type 2 diabetes whose blood sugar levels are still too high, even with their usual medications. Researchers want to compare a new once-a-week insulin treatment called IcoSema with an older, daily insulin called glargine. The main goal is to see how well each treatment lowers blood sugar (measured by HbA1c) and if there are any differences in safety, like the risk of very low blood sugar. They will also look at how treatments affect body weight, time spent with healthy blood sugar levels, and how satisfied people are with their treatment. This is a crucial step in developing new and potentially easier ways to manage type 2 diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novo Nordisk A/S

Enrolment target

136

Start

03 Oct 2023

Type 2 diabetes

What is this study about?

This study, known as COMBINE 4, is looking into new ways to help people living with type 2 diabetes. Sometimes, even with regular medications, blood sugar levels can be difficult to manage. This trial is hoping to find a better solution for those who are struggling to get their blood sugar under control.

The main idea is to compare two types of insulin treatments. One is a new treatment called IcoSema, which is designed to be taken just once a week. The other is a daily insulin called glargine, which is often used already. Researchers want to see which one works better at lowering blood sugar levels over 40 weeks, and if the new weekly treatment is as safe as the daily one. They are especially interested in reducing the risk of very low blood sugar, which can be a concern with insulin.

Beyond simply lowering blood sugar, the study will also look at other important aspects of living with diabetes. For example, they'll check if the treatments affect body weight, how much time people spend with their blood sugar in a healthy range, and how happy people are with their treatment overall. This detailed look helps scientists understand the full picture of how these treatments might impact someone's daily life.

Key takeaways

This study compares a new weekly insulin (IcoSema) with standard daily insulin (glargine) for type 2 diabetes.
It's for adults whose blood sugar isn't well controlled with current oral medicines.
The main goal is to see which treatment better lowers blood sugar (HbA1c) and is safer.
It also checks effects on body weight, time with healthy blood sugar, and patient satisfaction.
Participation involves clinic visits, blood tests, wearing a blood sugar monitor, and questionnaires over about 40 weeks.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or older. Both men and women can join.

The study is specifically looking for people who have type 2 diabetes. Importantly, your diabetes should not be fully controlled by the medications you're currently taking by mouth. This means your blood sugar levels are still higher than they should be, even with your current treatment plan.

If you fit these general descriptions, the study team will then look at more detailed medical information to make sure it's safe and appropriate for you to participate.

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 your current diabetes medications taken by mouth, but your blood sugar is still too high?
Are you willing and able to attend regular clinic appointments and use a blood sugar monitor?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it would last for about 40 weeks, which is roughly 9 to 10 months, plus a short follow-up period. You would receive either the new weekly insulin (IcoSema) or the daily insulin (glargine), along with some other common diabetes medications you might already be taking, such as dapagliflozin, metformin, or pioglitazone. All medications would be provided.

You would need to attend several visits to the clinic for check-ups, blood tests (including a measure called HbA1c), and to monitor your blood sugar control. You would also use a continuous glucose monitoring (CGM) system, like the Dexcom G6, for parts of the study to get a detailed picture of your blood sugar levels throughout the day and night. This involves wearing a small sensor on your skin. You'd also be asked to fill out questionnaires about how you feel about your treatment. The study team would carefully explain what each visit involves and when they are scheduled.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as receiving close medical care and access to a new treatment that might improve your blood sugar control. However, there are also potential risks, like with any medication, including the possibility of low blood sugar (hypoglycemia) or other side effects. All participants will be closely monitored by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Greece
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Unverified
Italy
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Unverified
Poland

Common questions

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 how well diabetes is being managed.

What does 'inadequately controlled' mean?

It means that despite taking your usual diabetes medications by mouth, your blood sugar levels are still higher than your doctor would like them to be.

What is continuous glucose monitoring (CGM)?

CGM is a way to track your blood sugar levels throughout the day and night using a small sensor placed on your skin. It gives a more complete picture than just finger-prick tests.

Is this a new medication?

The study is looking at IcoSema, which is a new type of insulin treatment designed to be taken once a week. It’s being compared to a daily insulin that is already widely used.

What is the difference between Level 2 and Level 3 hypoglycaemia?

Level 2 means your blood sugar is low enough to cause symptoms and needs treatment (below 3.0 mmol/L). Level 3, or severe hypoglycaemia, means your blood sugar is so low you need help from another person to recover.