Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus
This study is investigating a new medication, Rezpegaldesleukin, for individuals who have recently been diagnosed with Type 1 Diabetes (within 100 days). The main goal is to explore whether this medicine can help the body's own cells continue to produce insulin. Participants aged 8 to 45 will be randomly assigned to receive either the new medicine or a placebo (a dummy treatment, like a sugar pill, that contains no active medicine). Neither the patient, their doctors, nor the researchers will know who is receiving which treatment. The medicine or placebo will be given by injection every two weeks for six months, followed by another six months of observation. This is a Phase 2 study, meaning it's still in the early stages of testing. All care and monitoring will be provided in a supportive environment.
En un coup d'œil
De quoi parle cette étude ?
This research study is about a new medicine called Rezpegaldesleukin for people who have recently been told they have Type 1 Diabetes. When someone has Type 1 Diabetes, their body's immune system mistakenly attacks and destroys the cells in the pancreas that make insulin. Insulin is a vital hormone that helps turn sugar from food into energy for the body. Without enough insulin, blood sugar levels can become too high, which can lead to serious health problems.
The researchers want to see if Rezpegaldesleukin can help protect these insulin-making cells, allowing the body to keep making some of its own insulin for longer. This could potentially make managing Type 1 Diabetes easier in the future. It's important to remember that this is a research study, and we're still learning about this new medicine. Studies like this are how we find better ways to treat medical conditions.
In this study, participants will be randomly chosen to receive either the new medicine or a placebo. A placebo looks just like the real medicine but doesn't contain any active ingredients. This helps researchers fairly compare how well the new medicine works. Neither you, your doctors, nor the study team will know which treatment you are receiving until after the study is over. This is called a "double-masked" study and it's a standard practice in medical research to ensure the results are as accurate as possible.
Points clés
- This study is testing a new medicine for people recently diagnosed with Type 1 Diabetes.
- The aim is to see if the medicine can help the body keep making its own insulin.
- Participants will receive the new medicine or a dummy treatment (placebo) by injection.
- The study involves regular clinic visits for injections and health checks over about a year.
- Taking part helps researchers learn and improve treatments for Type 1 Diabetes.
- You can stop participating at any time without affecting your medical care.
Qui peut être éligible ?
To join this study, you must be between 8 and 45 years old. A key requirement is that you must have been diagnosed with Type 1 Diabetes within the last 100 days. Also, blood tests must show specific markers that confirm your immune system has recently attacked your insulin-producing cells, and you still have some insulin-producing ability.
You also need to be at a healthy weight for your age and be willing to actively manage your diabetes. There are also specific requirements about having certain vaccinations and being free from certain viral infections before starting the study. For younger participants, a parent or guardian will need to give permission.
It's important to discuss all your health conditions and medications with the study team to ensure this study is safe and right for you. They will review all criteria carefully to see if you are a good fit.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Are you between 8 and 45 years old?
- Were you diagnosed with Type 1 Diabetes within the last 100 days?
- Do blood tests show your immune system has recently attacked your insulin cells?
- Do you still have some ability to make your own insulin?
- Are you willing to actively manage your diabetes with your healthcare team?
- Are you able to attend all clinic visits for about a year?
En quoi consiste la participation ?
If you decide to participate, you will receive either the study medicine or a placebo injection under the skin every two weeks for about six months (26 weeks). These injections will be given at the study clinic. You'll need to visit the clinic regularly for these injections and for important medical tests. These tests include blood tests to measure your insulin levels and check your general health, particularly at the beginning of the study, and then at 3, 6, and 12 months. After the six months of treatment, you will continue to have follow-up visits for another six months, bringing the total time you’re involved in the study to about a year. During this time, you'll continue to manage your diabetes as you normally would, with support from the study team.
Risques et avantages potentiels
Emplacements (3)
- University of PittsburghCode postal vérifiéPittsburgh, United States· Recrutement
- Vanderbilt UniversityCode postal vérifiéNashville, United States· Pas encore en recrutement
- University of British ColumbiaCode postal vérifiéVancouver, Canada· Pas encore en recrutement
Questions fréquentes
What is a 'Phase 2 study'?
Phase 2 means this is an early stage of testing. The treatment has been found safe in a small number of people and now more information on its safety and effectiveness is being gathered in a larger group.
Qu'est-ce qu'un placebo ?
A placebo is a dummy treatment. It looks exactly like the real medicine but doesn't contain any active ingredients. This helps researchers compare the real medicine's effects fairly.
Saurai-je si je reçois le médicament ou le placebo ?
No, this is a 'double-masked' study, meaning neither you, your doctor, nor the researchers will know who is receiving which treatment until the study is complete. This helps keep the results unbiased.
Combien de temps serai-je impliqué dans l'étude ?
You will receive treatment or placebo injections for about six months (26 weeks). After that, you'll have follow-up visits for another six months, making your total participation about one year.
Puis-je arrêter de participer à l'étude si je change d'avis ?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.
Comment en savoir plus
Jessica Conaty
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Intéressé à participer ?
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