SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes
This study is looking into a new treatment called SAB-142 for people who have recently been diagnosed with Type 1 Diabetes. The main goal is to find out if this treatment can help slow down the progression of the disease and if it is safe to use. Researchers are comparing different doses of SAB-142 with a 'dummy' drug (placebo) to see their effects. Participants will be between 5 and 40 years old and will have been diagnosed with Type 1 Diabetes within the last 100 days. This is a 'Phase 2' study, meaning scientists are still testing the drug to see how well it works and if it has any side effects before it can be widely available.
At a glance
What is this study about?
This research study is focused on a new medication called SAB-142, and it's for people who have recently been diagnosed with Type 1 Diabetes. You might know that in Type 1 Diabetes, the body's immune system mistakenly attacks the cells in the pancreas that make insulin. This study aims to see if SAB-142 can help protect these insulin-producing cells from being destroyed, potentially slowing down the disease.
The study is designed to answer important questions about SAB-142: Does it work? How well does it work? And is it safe for people to take? To do this, some participants will receive a high dose of SAB-142, some a lower dose, and others will receive a 'placebo.' A placebo looks just like the study drug but contains no active medicine. This helps researchers fairly compare the effects of the actual drug.
Finding new ways to manage Type 1 Diabetes is very important. While this study is still in an earlier stage (Phase 2), the information collected will help doctors understand if SAB-142 could be a valuable treatment option in the future. All participants and the research team won't know who is getting which treatment until the end of the study, to ensure the results are unbiased.
Key takeaways
- A study testing a new drug, SAB-142, for recently diagnosed Type 1 Diabetes.
- Aims to see if it can slow down the disease and is safe.
- Participants receive high dose, low dose, or a dummy drug (placebo).
- Ages 5-40, diagnosed with Type 1 Diabetes within 100 days.
- Participation includes regular clinic visits and health checks.
- Voluntary, with the right to withdraw at any time.
Who may be eligible?
This study is for people who have recently been diagnosed with Type 1 Diabetes. To be considered, you should be between 5 and 40 years old and have received your diagnosis no more than 100 days before the study starts. If you were initially told you had Type 2 Diabetes but were later diagnosed with Type 1, the 100-day limit still applies from that first diagnosis date.
You also need to meet certain health requirements. For example, your body must still be making a certain level of natural insulin, which will be checked through a blood test. Doctors will also need to confirm your Type 1 Diabetes diagnosis using specific markers in your blood.
It's important that you, or your legal guardian if you're under 18, understand everything about the study and agree to participate. Female participants must be unable to become pregnant (for example, if they have undergone certain medical procedures or are past menopause), or be prepubescent.
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 5 and 40 years old?
- Have you been diagnosed with Type 1 Diabetes in the last 100 days?
- Is your body still making some natural insulin (as determined by a blood test)?
- Have you tested positive for specific Type 1 Diabetes markers in your blood?
- If female, are you unable to become pregnant or are you prepubescent?
What does participation involve?
If you decide to take part, you'll be assigned to one of three groups by chance: a high dose of SAB-142, a low dose of SAB-142, or a placebo (a dummy drug). You, or your child, will receive the study treatment, and the study team will ask you to visit the clinic regularly. During these visits, doctors will perform various checks, including blood tests and other assessments, to see how the treatment is affecting you and to monitor your overall health.
Throughout the study, you'll be closely monitored for any side effects or changes in your health. The duration of your participation will involve these regular visits and follow-up appointments. More details on the exact number and timing of visits would be provided by the study team, along with information about how long you'd be receiving the study medication and how long the follow-up period would be.
Potential risks and benefits
Locations (71)
- University of California San Francisco Benioff Children's HospitalVerified postcodeSan Francisco, United States· Recruiting
- San Jose Clinical Trials, LLCVerified postcodeSan Jose, United States· Recruiting
- University of Colorado - Barbara Davis Center for DiabetesVerified postcodeAurora, United States· Recruiting
- University of Florida College of MedicineVerified postcodeGainesville, United States· Recruiting
- University of Miami - Gables One TowerVerified postcodeMiami, United States· Recruiting
- Children's Healthcare of Atlanta (CHOA) - Center for Advanced PediatricsVerified postcodeAtlanta, United States· Recruiting
- IUH - Riley Hospital for Children - Riley Outpatient Center - Pediatric Diabetes & EndocrinologyVerified postcodeIndianapolis, United States· Not yet recruiting
- Harvard Medical School - Joslin Diabetes Center and Joslin Clinical (JDS)Verified postcodeBoston, United States· Not yet recruiting
- Children's Mercy Hospital Kansas City - Pediatric Care ClinicVerified postcodeKansas City, United States· Recruiting
- University of New Mexico HospitalVerified postcodeAlbuquerque, United States· Not yet recruiting
- University at Buffalo MD Physicians GroupVerified postcodeBuffalo, United States· Not yet recruiting
- Asheville Clinical ResearchVerified postcodeAsheville, United States· Recruiting
Common questions
What is Type 1 Diabetes?
Type 1 Diabetes is a condition where your body's immune system mistakenly attacks the cells in your pancreas that produce insulin, a hormone needed to turn food into energy.
What is a 'Phase 2' study?
A Phase 2 study is an early stage of clinical research where scientists test a new drug in a small group of people to see if it works and if it's safe, before wider testing.
Will I know if I'm getting the real drug or a dummy drug?
No, neither you nor the study team will know whether you are receiving the active drug (SAB-142) or the placebo (dummy drug) until the study is over. This helps ensure fair results.
What is a 'placebo'?
A placebo is a substance or treatment that looks exactly like the study drug but does not contain any active medicine. It helps researchers compare the true effects of the study drug.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any point, for any reason. Your decision will not affect your usual medical care.
How to find out more
Senior Manager Clinical Operations
Always speak to your GP or specialist before deciding to take part in a study.
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