A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes
This study is investigating a medicine called Teplizumab for young people with Type 1 Diabetes. Participants, aged 1 to 25, who have been recently diagnosed with Stage 3 Type 1 Diabetes, will receive either Teplizumab or a dummy medicine (placebo) through a drip. The main aim is to see if Teplizumab helps improve blood sugar control and reduces the amount of insulin needed over 52 weeks. Researchers will closely monitor participants' health throughout the study, which lasts about 18 months, to understand both the benefits and any potential side effects. This research could help find new ways to manage Type 1 Diabetes better.
At a glance
What is this study about?
This study is focusing on Type 1 Diabetes, specifically for younger individuals aged 1 to 25 who have recently been diagnosed with what doctors call 'Stage 3' of the condition. Type 1 Diabetes is a lifelong condition where the body's immune system mistakenly attacks and destroys the cells in the pancreas that produce insulin. Insulin is a hormone essential for turning sugar from food into energy. Stage 3 means that insulin production has significantly decreased, leading to high blood sugar levels and usually requiring insulin injections.
The main goal of this research is to test a medicine called Teplizumab. We want to see if Teplizumab can help people manage their blood sugar levels more easily and potentially reduce how much insulin they need compared to a dummy medicine (called a placebo). Teplizumab works by targeting certain immune cells, and it's hoped that by doing so, it can help protect the remaining insulin-producing cells.
Participants will receive the study medicine through an intravenous (IV) infusion, which means it will be given directly into a vein. The study will closely follow participants for about 18 months to understand how well Teplizumab works and if it has any side effects. Finding new and better ways to manage Type 1 Diabetes is really important for improving the lives of individuals living with this condition.
Key takeaways
- This study is for young people (1-25 years old) with recently diagnosed Stage 3 Type 1 Diabetes.
- It tests a new medicine called Teplizumab against a dummy medicine (placebo).
- The goal is to improve blood sugar control and reduce insulin needs.
- Participation involves regular clinic visits and continues your standard insulin treatment.
- The study lasts about 18 months and carefully monitors your health.
- You won't know if you're getting the active medicine or the placebo.
Who may be eligible?
To be part of this study, you need to be aged between 1 and 25 years old at the time you agree to take part. You must also have been recently diagnosed with 'Stage 3' Type 1 Diabetes, specifically within 8 weeks (about two months) before the study treatment begins.
Doctors will also check your blood for certain 'autoantibodies' – these are special proteins the immune system makes that accidentally attack healthy cells in Type 1 Diabetes. You need to have at least one of these autoantibodies to be eligible. They will also check a measure called C-peptide to confirm that your body is still making a small amount of insulin.
Both males and females can join the study. If you are female and could become pregnant, you would need to use a highly effective birth control method during the study and for a period afterwards. If you are breastfeeding, you would need to stop and pump your milk, discarding it for a period during and after the study treatment.
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 between 1 and 25 years old?
- Have you been diagnosed with Stage 3 Type 1 Diabetes in the last 8 weeks?
- Are you able to get the study medicine through a drip?
- Are you willing to attend regular clinic visits for about 18 months?
- If you are female and could get pregnant, are you willing to use effective birth control?
What does participation involve?
If you decide to take part, the study will last for approximately 84 weeks, which is about 18 months. You will receive either Teplizumab or a placebo (a dummy medicine) through a drip, which is given into a vein. This study is 'double-blind,' meaning neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. You will also continue with your usual insulin treatment.
Throughout the 18 months, you will have regular visits to the clinic for medical check-ups, blood tests, and to assess your blood sugar control. The research team will monitor your health closely and record any changes or side effects. These visits are important for understanding how the medicine works and for keeping you safe. After the treatment period, there will be follow-up visits to see how you are doing.
Potential risks and benefits
Locations (153)
- Scottsdale Clinical Trials- Site Number : 8400044Verified postcodeScottsdale, United States· Recruiting
- Marvel Clinical Research- Site Number : 8400042Verified postcodeHuntington Beach, United States· Recruiting
- University of California San Francisco - Mission Bay- Site Number : 8400011Verified postcodeSan Francisco, United States· Recruiting
- Barbara Davis Center for Childhood Diabetes- Site Number : 8400031Verified postcodeAurora, United States· Recruiting
- Yale University School of Medicine- Site Number : 8400005Verified postcodeNew Haven, United States· Recruiting
- University of Florida College of Medicine- Site Number : 8400054Verified postcodeGainesville, United States· Recruiting
- Encore Medical Research - Hollywood- Site Number : 8400061Verified postcodeHollywood, United States· Recruiting
- University of South Florida- Site Number : 8400013Verified postcodeTampa, United States· Recruiting
- AdventHealth Winter Park- Site Number : 8400033Verified postcodeWinter Park, United States· Recruiting
- Atlanta Diabetes Associates- Site Number : 8400036Verified postcodeAtlanta, United States· Recruiting
- IACT Health - Columbus - Talbotton Road- Site Number : 8400003Verified postcodeColumbus, United States· Recruiting
- Institute of Endocrinology Diabetes, Health & Hormones- Site Number : 8400050Verified postcodeStockbridge, United States· Recruiting
Common questions
What is Stage 3 Type 1 Diabetes?
Stage 3 means you have symptoms of Type 1 Diabetes, like high blood sugar, and your body is producing very little insulin, requiring insulin shots.
What is Teplizumab?
Teplizumab is a new medicine that aims to protect the cells in your body that make insulin, potentially helping to manage Type 1 Diabetes.
What is a 'placebo'?
A placebo is a dummy medicine that looks exactly like the study drug but contains no active ingredients. It helps researchers fairly compare the new medicine's effects.
Will I still take my regular insulin?
Yes, all participants in this study will continue to take their standard insulin therapy as prescribed by their doctor.
How long will I be in the study?
Each participant will be in the study for about 18 months in total, including treatment and follow-up.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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