Phase 2 Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with Stage 3 Type 1 diabetes recently, following standard diagnostic guidelines, and who can be enrolled within 6 months of their diagnosis and within 37 days of their screening visit.
• People who have at least one positive diabetes-related autoantibody (a marker the immune system is attacking the pancreas).
• People whose pancreas still produces a measurable minimum amount of insulin, confirmed through a specific drink-based test done before enrolment.
• People aged 9 up to (but not including) 21 years old at the time of enrolment.
• People who weigh more than 30 kg (about 66 pounds).
• People whose Body Mass Index (BMI) is below the 95th percentile for their age and gender.
• People who are willing to follow an intensive diabetes management plan throughout the study.
• Female participants of childbearing potential who are not currently pregnant, are willing to avoid becoming pregnant or breastfeeding during the study, and are willing to take pregnancy tests before certain study visits.
• Female participants of childbearing potential who are willing to use an accepted form of contraception (such as oral or injectable contraceptives, patches, diaphragm, intrauterine device, condoms with spermicide, documented surgical sterilisation of themselves or their partner, or abstinence).
• Male participants who are willing to use abstinence or an accepted contraceptive method throughout the study, use a condom during the treatment period and for at least 90 days after the last dose, and agree not to donate sperm during that time.
• People (and their legal guardian, if applicable) who are willing and able to give informed consent, and in the case of children, provide assent as appropriate.
• People who have enough cognitive ability, as judged by the study investigator, to understand and consent to participation.
• People (and their legal guardian, if applicable) who can read and understand English or Spanish.
• People who are fully up to date with all vaccinations recommended for their age.
• People who have received a flu vaccine if the study is taking place during flu season.
• People who are willing to avoid receiving any live vaccines during the treatment period.
• People who are willing to stop taking (at least 30 days before screening) and avoid using any non-insulin blood sugar–lowering medications during the study (such as GLP-1 agonists, including those used for weight loss, as well as certain other diabetes or blood sugar medications).

Who may not be able to join:

• People who have previously been treated with ATG (anti-thymocyte globulin), or who have a known allergy to ATG or to products derived from rabbits.
• People whose blood test at screening shows low white blood cell counts, low neutrophil counts, or low lymphocyte counts (signs of a weakened immune system).
• People whose blood test shows a low platelet count or low haemoglobin (anaemia).
• People whose blood test shows an unusually high white blood cell count.
• People who have an ongoing infection, or who have recently been hospitalised or treated with intravenous antibiotics for a major infection within 30 days before enrolment.
• People who show active signs or symptoms of an acute infection at the time of enrolment.
• People who have evidence of a current or past tuberculosis infection, based on a specific immune test or a positive test for latent (inactive) tuberculosis.
• People who have evidence of current or past HIV, Hepatitis B, or current Hepatitis C infection.
• People with a history of serious bacterial, viral, fungal, or other opportunistic infections.
• People who have had active signs or symptoms of CMV (cytomegalovirus) or EBV (Epstein-Barr virus) illness lasting more than 7 days within 30 days of enrolment.
• People who have tested positive for CMV or EBV on a PCR test within 30 days before enrolment.
• People who have tested positive for COVID-19 on a rapid antigen test within 3 days of enrolment.
• People with a history of certain heart conditions (such as problems with heart muscle function, certain irregular heart rhythms, or abnormal ECG results that have not been cleared by a heart specialist).
• People whose blood pressure (top or bottom number) is below the 5th percentile for their age, gender, and height on two out of three measurements.
• People whose resting pulse is below the 2nd percentile for their age and gender on two out of three measurements.
• People with a history of fainting episodes related to low blood pressure.
• People with a history of cancer, other than certain skin cancers.
• People who are currently using or have previously used immune-modifying medications (including systemic steroids), or who participated in a research study involving immune-modifying treatment (participation in a placebo-only arm may be acceptable — confirm with trial site).
• People who have previously or are currently using Teplizumab.
• People who are currently using medications known to affect blood sugar or glucose tolerance (topical steroids are the only steroid type permitted).
• People who would need to use any of the following medications during the study: beta blockers, certain seizure medications (carbamazepine, phenobarbital, phenytoin), certain blood pressure medications, cholesterol-lowering medications (HMG-CoA reductase inhibitors), lithium, theophylline, clonidine.
• People who have received a live vaccine (such as chickenpox, MMR, certain flu nasal sprays, BCG, or smallpox vaccine) within the 90 days before enrolment.
• People with a known allergic reaction to any of the study medications or their components.
• People who are unable to swallow pills (this is tested with a practice tablet at the screening visit).
• People with a known significant allergy (such as anaphylaxis) to milk or soy proteins, as these are present in the Boost drink used during a required study test.
• People who currently use hydroxyurea or who cannot avoid using it during the study, as it interferes with the accuracy of the glucose monitoring device used in the study.
• People with a known allergy or severe reaction to adhesive or tape that would be required during the study.
• People currently participating in another research study involving diabetes treatment or immune system modification, unless they can confirm they were in a placebo-only arm.
• People with certain other medical conditions or medication use that the study doctor, chair, or medical monitor believes could affect study results or participant safety, including: alcohol or drug misuse; untreated or inadequately treated mental illness; liver disease or abnormal liver blood tests; kidney disease or abnormal kidney blood tests; autoimmune diseases other than stable, treated underactive thyroid, Graves' disease, or coeliac disease that is symptom-free on a gluten-free diet; certain nervous system disorders (including Guillain-Barré syndrome, multiple sclerosis, or progressive multifocal leukoencephalopathy); a history of multiple abdominal surgeries or increased risk of bowel obstruction; or any other condition or lab result the investigator believes would interfere with the study or participant safety.

Important: Always verify eligibility with the trial site directly before applying.