A Trial to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR4 Compared with Insulin Degludec and Insulin Icodec in Participants with Type 2 Diabetes
Living with type 2 diabetes often involves managing blood sugar levels every day. Insulin injections are a common way to do this. This early-stage clinical trial is testing a new experimental insulin called GZR4. Researchers want to find out how GZR4 behaves inside the human body compared with two modern, long-acting insulins that are already in use: insulin degludec and insulin icodec. The study looks at how quickly the medicine enters the blood, how well it controls blood glucose, how long it stays active, and whether it causes any unwanted side effects. Taking part helps scientists understand if this new medicine could become a safe, effective option for people managing type 2 diabetes in the future. The trial is open to adults aged 18 and older with type 2 diabetes who meet specific health checks.
At a glance
What is this study about?
Type 2 diabetes is a condition where the body cannot properly control the amount of sugar in the blood. Over time, high blood sugar can cause damage to the heart, eyes, kidneys, and nerves. Many people need medicines, including insulin, to help keep their blood sugar in a healthy range. Scientists are always searching for newer insulins that are easier to use, work steadily over time, and cause fewer side effects.
This trial focuses on a new investigational insulin called GZR4. It is being tested against two existing long-acting insulins: insulin degludec (which is taken once a day) and insulin icodec (which is designed to be taken once a week). Researchers want to compare how these different insulins work in the body, a process doctors call pharmacokinetics and pharmacodynamics.
Because this is an early-stage study, the primary goal is safety. Doctors will closely track how the body processes GZR4, how well it lowers blood sugar levels, and how well volunteers tolerate it. The results from this trial will help researchers decide if GZR4 should be developed further as a future treatment option.
Key takeaways
- Tests a new experimental insulin called GZR4 for type 2 diabetes.
- Compares GZR4 against two approved insulins: degludec and icodec.
- Focuses on how the body handles the medicine and overall safety.
- Open to adults aged 18 and over with type 2 diabetes.
- Involves detailed blood tests, health checks, and clinic visits.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is designed for adults aged 18 and older who have been diagnosed with type 2 diabetes. Both men and women can join. Because this is an early-stage pharmacology study, the study doctors will check your overall health very carefully before you can take part.
To be eligible, your diabetes needs to be relatively stable, and you will need to meet specific health criteria set by the research team. This usually means having blood tests, heart checks, and a review of any other medical conditions you might have.
You might not be able to join if you have certain health complications, severe kidney or liver problems, or if you are taking specific medications that could interfere with the study. Women who are pregnant or breastfeeding are generally unable 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.
- I am aged 18 or older.
- I have been diagnosed with type 2 diabetes.
- I am able to attend clinic visits and possibly short overnight stays.
- I am willing to have regular blood tests and health monitoring.
- I am not currently pregnant or planning to become pregnant during the study.
What does participation involve?
Taking part in this study involves several clinic visits. Before anything begins, you will attend a screening appointment where the research team will explain the trial, take blood and urine samples, check your heart with an ECG, and review your medical history.
If you join, you will receive doses of the study insulins under close medical supervision. You may need to spend some time staying at the clinical research unit so the doctors can take regular blood samples over several hours or days. This allows them to see exactly how the insulin enters your bloodstream and lowers your blood sugar.
Throughout the study, your health will be carefully watched. You will have regular checks for side effects, including checks for low blood sugar (hypoglycaemia). The total duration of the trial will depend on the exact dosing schedule, which the study team will discuss with you in detail.
Potential risks and benefits
Locations (1)
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Common questions
What is the main goal of this trial?
The goal is to see how the new insulin GZR4 works in the body and how safe it is compared to two existing insulins, degludec and icodec.
Is GZR4 already an approved medicine?
No, GZR4 is an experimental medicine. This study is part of the early testing process to find out if it is safe and effective.
Will I have to pay for the study treatment?
No, all study medicines, tests, and medical checks are provided free of charge, and travel expenses are often reimbursed.
Can I leave the study if I change my mind?
Yes, you can leave the study at any point. Your decision will not affect your regular medical care or relationship with your doctor.
Will I still see my regular GP or diabetes specialist?
Yes, you will continue with your normal NHS care, and the study team will usually keep your GP updated about your participation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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