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.
एक नजर में
यह अध्ययन किस बारे में है?
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.
मुख्य निष्कर्ष
- 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.
- आप किसी भी समय भाग लेना बंद कर सकते हैं बिना आपकी चिकित्सा देखभाल पर प्रभाव डाले।.
कौन पात्र हो सकता है?
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.
क्या यह अध्ययन आपके लिए उपयुक्त हो सकता है?
यह देखने के लिए इन त्वरित प्रश्नों का उत्तर दें कि क्या आप पात्र हो सकते हैं। यह केवल एक मार्गदर्शिका है — अंतिम निर्णय शोध टीम द्वारा लिया जाता है।.
- 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?
भागीदारी में क्या शामिल है?
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.
संभावित जोखिम और लाभ
स्थान (3)
- University of Pittsburghसत्यापित पोस्टकोडPittsburgh, United States· भर्ती
- Vanderbilt Universityसत्यापित पोस्टकोडनैशविल, संयुक्त राज्य अमेरिका· अभी भर्ती नहीं हो रही है
- ब्रिटिश कोलंबिया विश्वविद्यालयसत्यापित पोस्टकोडवैंकूवर, कनाडा· अभी भर्ती नहीं हो रही है
सामान्य प्रश्न
'फेज 2 अध्ययन' क्या है?
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.
प्लेसबो क्या है?
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.
Will I know if I'm getting the medicine or the 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.
मैं इस अध्ययन में कितने समय तक शामिल रहूँगा?
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.
अगर मैं अपना मन बदल लूँ तो क्या मैं अध्ययन में भाग लेना बंद कर सकता हूँ?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.
और अधिक जानने के लिए कैसे पता करें
Jessica Conaty
किसी अध्ययन में भाग लेने का निर्णय लेने से पहले हमेशा अपने जीपी या विशेषज्ञ से बात करें।.
भाग लेने में रुचि रखते हैं?
चर्चा
समुदाय चर्चा
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