Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Trial to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR33 Compared with Insulin Degludec at steady state in participants with Type 1 Diabetes

This study is looking at a new type of insulin, called GZR33, and comparing it to an insulin that's already available, called Degludec. It involves adult volunteers who have type 1 diabetes. The main goals are to understand how the new insulin behaves in the body (pharmacodynamics and pharmacokinetics) and to check its safety and how well people tolerate it. This is a very early stage of research, sometimes called Phase I, which means it's one of the first times the new insulin is being tested in humans. The researchers hope to gather important information about this potential new treatment for type 1 diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Gan & Lee Pharmaceuticals USA Corp.

Enrolment target

Start

15 Oct 2025

Type 1 diabetes Mellitus

What is this study about?

This study is designed to explore a new insulin treatment called GZR33. If you have type 1 diabetes, you know how important insulin is for managing your blood sugar. Scientists are always working to find new and improved ways to help people with diabetes live healthier lives. This particular study is comparing the new insulin GZR33 with an insulin that many people already use, called Degludec.

The main aim is to understand two key things about these insulins. Firstly, how they work inside your body to control blood sugar (this is called pharmacodynamics). Secondly, how your body processes the insulin – how quickly it's absorbed, how long it stays in your system, and how it's eventually removed (this is called pharmacokinetics). The study will also be carefully monitoring how safe the new insulin is and if people can take it without too many side effects.

This kind of research is very important because it helps us understand if a new medicine might be a good option for future treatment. Because it's an early-stage study (sometimes called Phase I), it's about gathering initial information to help guide further research. The information learned from studies like this helps doctors and researchers decide if a new treatment is promising enough to be tested in larger groups of people.

Key takeaways

This study is comparing a new insulin (GZR33) with an existing one (Degludec).
It's for adults with type 1 diabetes.
The main aims are to check safety and how the insulins work in the body.
This is an early-stage (Phase I) study.
Participation involves close monitoring at a clinic.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, and there is no upper age limit. Both men and women are welcome to take part in this research.

Importantly, you must have type 1 diabetes to be considered for this study. The researchers will be looking for specific medical details about your diabetes and overall health to make sure you're a good fit and that it's safe for you to participate.

There might be other health conditions or medications that would prevent you from joining, so the study team will ask you questions about your medical history to check if you meet all the requirements.

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 attend study visits as required?
Are you willing to follow all study procedures?
Are you happy to discuss your full medical history with the study team?

Answer every question to see your result.

What does participation involve?

The detailed plan for taking part isn't provided, but generally for this type of early insulin study, it might involve a screening visit to check if you're suitable. If you qualify, you would likely spend some time at a special clinic or hospital unit. This often involves staying overnight or for a few days so that researchers can closely monitor your blood sugar and how the insulins are working.

You would receive either the new insulin GZR33 or the existing insulin Degludec. There would be regular blood tests to check insulin levels and blood sugar, and other tests to monitor how your body is responding. You would also be asked about any side effects you might experience. After this main period, there might be follow-up visits or phone calls to check on your health. The total time you would be involved in the study would be explained to you before you agree to take part.

Potential risks and benefits

Potential benefits of taking part could include contributing to medical knowledge about new diabetes treatments, and you would receive careful medical attention throughout the study. However, there's no guarantee the new insulin will benefit your health directly. Potential risks might include side effects from the insulin, such as low blood sugar (hypoglycaemia), or discomfort from blood draws. Like all medical studies, there's a chance of unexpected side effects. You have the right 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
Germany

Common questions

What is type 1 diabetes?

Type 1 diabetes is a condition where your body's immune system mistakenly attacks and destroys the cells in the pancreas that make insulin. This means your body can't produce its own insulin, which is essential to control blood sugar.

What is insulin GZR33?

Insulin GZR33 is a new insulin treatment that scientists are investigating. This study is one of the first steps to understand how it works and if it's safe for people with type 1 diabetes.

What is insulin Degludec?

Insulin Degludec is a long-acting insulin that is already approved and used by many people with diabetes to help manage their blood sugar levels.

What does 'Phase I' mean for a study?

Phase I means this is a very early stage of testing a new medicine in humans. The main goals are to check its safety, how well people tolerate it, and how it behaves in the body, rather than how effective it is over a long time.

Will I get paid to participate?

The information provided doesn't say if you will be paid. Clinical studies sometimes offer payment for time and travel, but this varies and should be discussed with the research team.