Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec when Switching from Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults with Type 2 Diabetes

Researchers are conducting a study to see if a new insulin that's taken once a week, called insulin icodec, is a good option for adults with type 2 diabetes. This new insulin is being compared to a common daily insulin treatment, Lantus. The main goal is to find out if the once-a-week insulin can control blood sugar as effectively as the daily one. The study will also look at how safe the new insulin is, how happy people are with their treatment, and how it affects their blood sugar levels throughout the day. This is an important step in developing new, potentially more convenient treatments for type 2 diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novo Nordisk A/S

Enrolment target

145

Start

26 Mar 2024

Type 2 Diabetes

What is this study about?

This study is all about finding a new way to manage type 2 diabetes. Many people with type 2 diabetes need to take insulin injections every day to keep their blood sugar levels healthy. This study is testing a new type of insulin that only needs to be taken once a week. It's called insulin icodec.

The researchers want to see if this new once-a-week insulin works as well as, or even better than, the daily insulin that many people currently use, such as Lantus. They'll be carefully checking blood sugar levels to see if the new insulin helps to keep them stable. They'll also be looking at how safe the new insulin is and if it causes any unwanted side effects, especially very low blood sugar.

Ultimately, this study aims to find out if a weekly insulin injection could be a convenient and effective option for people with type 2 diabetes, potentially making it easier to manage their condition.

Key takeaways

This study is testing a new once-a-week insulin for type 2 diabetes.
It aims to see if it's safe and as effective as daily insulin.
Blood sugar control and treatment satisfaction are key measures.
Participants will be adults with type 2 diabetes currently on daily insulin.

Who may be eligible?

This study is looking for adult volunteers of any gender who have type 2 diabetes. You need to be 18 years old or older to take part.

Currently, you should be taking daily long-acting (basal) insulin to manage your type 2 diabetes. This study will involve switching from your current daily insulin to either the new weekly insulin or another daily insulin for comparison.

There might be other specific health requirements or conditions that would make someone unsuitable for the study, but these would be discussed in detail with the study team.

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 currently taking a daily long-acting insulin?
Are you able to attend regular study visits?

Answer every question to see your result.

What does participation involve?

If you join this study, your participation will involve several visits to the study clinic over a period of about 6 months, plus some follow-up. You will be randomly assigned to receive either the new once-a-week insulin (insulin icodec) or a standard daily insulin (Lantus).

Throughout the study, you'll have regular check-ups, blood tests, and assessments of your blood sugar levels. You'll also be asked to keep track of your blood sugar at home and fill out questionnaires about how you feel about your treatment. The study team will provide all the medication and instructions you need.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving new treatments or close medical monitoring. However, there are also potential risks, including side effects from the medications, like low blood sugar (hypoglycaemia), or the possibility that the new treatment might not work as well for you. Your safety will be closely monitored by the study team. Remember, deciding whether or not to join is completely up to you, and you can withdraw from the study at any time without giving a reason.

Locations (4)

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
Spain
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Unverified
Bulgaria
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Unverified
Germany

Common questions

What is the new insulin being tested?

It's called insulin icodec, and it's designed to be taken once a week.

What is the main goal of this study?

To see if the once-a-week insulin is safe and works as well as daily insulin for controlling blood sugar in type 2 diabetes.

What does HbA1c mean?

HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of the treatments, and neither you nor the study team will know which one you are receiving.

How long will the study last?

The main part of the study where your blood sugar is checked will last for about 6 months, with some follow-up beyond that.