Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase I Randomized, Single-center, Double-blind, Two-period Crossover Trial to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR4 Compared with Insulin Icodec in Participants with Type 2 Diabetes.

This early-stage study is looking at a new insulin treatment, Insulin GZR4, for adults with type 2 diabetes. We're comparing it to another insulin, Insulin Icodec. The main aim is to understand how these insulins behave in the body, including how much medicine gets absorbed, how long it lasts, and its effects. We also want to check if they are safe to use and if people have any side effects. This is a "Phase I" study, meaning it's one of the first times this new insulin is being tested in humans. Studies like this help us learn more about potential new treatments for diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Gan & Lee Pharmaceuticals USA Corp.

Enrolment target

Start

19 Mar 2025

Type 2 Diabetes Mellitus

What is this study about?

This study is about exploring a new type of insulin for people who have type 2 diabetes. Insulin is a hormone that helps your body use sugar for energy, and people with type 2 diabetes often need extra help managing their blood sugar levels. In this study, we're testing a new insulin called Insulin GZR4. We're comparing it to another insulin called Insulin Icodec, which is also designed to help manage blood sugar.

The main goal is to understand how Insulin GZR4 works inside the human body. This includes seeing how much of the medicine gets into your system, how long it stays there, and how it affects your body. We'll also be carefully checking for any side effects and how well people tolerate the new insulin compared to the other one.

This is a 'Phase I' study, which means it’s one of the very first times this specific new insulin is being tested in people. These early studies are really important because they help us find out if a new treatment is safe and if it works as expected before it can be studied in more people.

Key takeaways

This study is testing a new insulin, Insulin GZR4, for type 2 diabetes.
It's an early-stage (Phase I) study focusing on safety and how the insulin works.
Adults aged 18 and over with type 2 diabetes can potentially join.
You would receive both test insulins at different times over the study period.
Your health would be closely monitored by a medical team.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.

Because this is a very early study, there will likely be other health requirements too. For example, you might need to have a specific type of type 2 diabetes or be on certain medications already. Also, some health conditions might mean you can't join.

The research team will carefully check your medical history and current health to see if this study is right for you. They will explain all the details clearly.

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 willing to potentially receive two different types of insulin during the study?
Are you able to attend regular clinic visits?
Are you willing to have blood tests and other health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either Insulin GZR4 or Insulin Icodec at different times during the study. This is called a 'crossover' design, meaning everyone gets both treatments at some point, but not at the same time. You will have regular visits to the study clinic where doctors and nurses will monitor your health, take blood and urine samples, and check your blood sugar levels. You'll be asked about any side effects you might experience. The total duration of your involvement, including all visits and follow-up, will be clearly explained to you before you agree to join.

Potential risks and benefits

Taking part in a study like this might offer a chance to try a new insulin treatment. While the study aims to understand the safety of the new insulin, there's always a possibility of unknown side effects, or that the treatment might not work for you. The medical team will monitor you closely for any issues, and you are free to leave 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
Germany

Common questions

What is 'Phase I' of a clinical trial?

Phase I is the earliest stage of human testing for a new medicine. It mainly checks if the treatment is safe and how it behaves in the body, usually in a small group of people.

What is the difference between Insulin GZR4 and Insulin Icodec?

Insulin GZR4 is a new type of insulin being tested. Insulin Icodec is another insulin used for comparison to see how GZR4 performs.

Will I know which insulin I'm getting?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which insulin you are receiving at any given time. This helps ensure fair results.

What does 'crossover trial' mean?

In a crossover trial, you will receive both treatments being tested (Insulin GZR4 and Insulin Icodec) at different points in the study, with a break in between. Everyone gets a chance to try both.

Will my regular diabetes care be affected?

The study team will discuss how your participation might affect your current diabetes management. You should always discuss any study participation with your regular doctor.