Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence study of a proposed biosimilar insulin glargine U300 with Toujeo®

This important study is looking at a new type of insulin called an 'biosimilar' for adults living with Type 1 diabetes. The main goal is to figure out if this new insulin acts the same way in the body as Toujeo®, a well-known insulin already used by many. This is a very early stage of testing, often called a Phase 1 study, which focuses on how the new medicine behaves in humans. It's about checking for similarities in how the insulin gets into the body and does its job, rather than testing its long-term effects. This step is crucial before a new medicine can be considered for wider use.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Biocon Sdn. Bhd.

Enrolment target

Start

20 Jun 2023

Type 1 Diabetes Mellitus

What is this study about?

This study is focused on people who have Type 1 diabetes. You might already be familiar with insulin, which is a medicine that helps your body control blood sugar levels when you have diabetes. This particular study is looking at a new version of an insulin called insulin glargine U300, which is currently available as a medicine called Toujeo®.

The researchers want to see if this new, similar version, often called a 'biosimilar', works in exactly the same way as Toujeo®. Think of it like comparing two different brands of a common household product – they both do the same job, even if they're made by different companies. For medicines, it's really important to prove they are alike before they can be used.

This is a very early study, known as a Phase 1 or 'bioequivalence' study. This means it's not looking at how well the medicine treats your diabetes over a long time, but rather whether the new insulin gets absorbed and acts in your body in the same way as Toujeo®. This step is essential to make sure any new insulin is as safe and effective as the original one.

Key takeaways

Tests a new insulin for Type 1 diabetes.
Compares it to existing insulin, Toujeo®.
Aims to check if they work the same way in the body.
For adults aged 18 and over.
Important for future insulin options.

Who may be eligible?

This study is open to adults aged 18 and over. It doesn't matter if you are male or female, as long as you meet the other requirements. People with Type 1 diabetes are invited to take part.

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 1 diabetes?
Are you able to visit the clinic for appointments?
Are you comfortable with blood tests and medical checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new insulin or Toujeo®, and doctors will carefully monitor how it works in your body. This will involve several visits to the clinic, where you might have blood samples taken and other health checks. The study team will explain everything in detail, including how long each visit might take and the total time you'd be involved. All medication and assessments related to the study will be provided by the study team.

Potential risks and benefits

Taking part in any study has potential benefits, such as contributing to medical knowledge and potentially getting access to new treatments. However, there are also potential risks involved, like side effects from the medication or discomfort from tests. The study team will explain all known risks. Remember, you can always change your mind and leave the study at any point, without having to give a reason, and it won't affect your future 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
Germany

Common questions

What is Type 1 diabetes?

Type 1 diabetes is a condition where your body can't make insulin, a hormone needed to turn sugar into energy.

What is a 'biosimilar' insulin?

A biosimilar insulin is a new version of an existing insulin that works the same way and has the same safety and effectiveness.

What is Toujeo®?

Toujeo® is a brand of insulin glargine U300, a long-acting insulin used by people with diabetes.

Why is this study important?

This study helps find out if new, potentially more affordable, versions of insulin are just as good as existing ones.

Will taking part affect my usual diabetes care?

The study team will discuss how your participation might affect your current diabetes routine and ensure your care is maintained.