Phase 2 Type 2 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 are Japanese (born in Japan, or of Japanese ethnicity born outside Japan with all four grandparents being ethnic Japanese born in Japan), aged 1 to 34 years old at the time of signing the consent form
• People who have been diagnosed with Stage 2 Type 1 Diabetes, which means testing positive for two or more specific diabetes-related antibodies in the blood
• People whose blood sugar results from a glucose tolerance test or HbA1c blood test show early blood sugar problems, but not yet full diabetes
• People who are otherwise in good general health, as confirmed by a medical check-up including physical examination, blood tests, and a heart tracing (ECG)
• People who are up to date with their routine vaccinations for their age group before joining the trial
• Female participants who are either unable to become pregnant, or who agree to use reliable contraception or remain abstinent from the time of signing the consent form until at least 3 months and 2 weeks after being assigned to a treatment group, and who also agree not to donate or freeze eggs during this period
• Female participants who are capable of becoming pregnant must have a negative pregnancy test within 48 hours before receiving the study treatment

Who may not be able to join:

• People with significant health conditions affecting the heart, lungs, digestive system, skin, liver, kidneys, blood, nerves, muscles, joints, mental health, eyes, or with signs of an active illness (other than Stage 2 Type 1 Diabetes)
• People who have had COVID-19 symptoms or a confirmed COVID-19 infection in the past 4 weeks, or who were previously hospitalised or placed on a breathing machine due to severe COVID-19
• People who have recently donated blood (timing restrictions vary by age, volume, and donation type — confirm with trial site) or received a blood transfusion within 2 months before joining
• People with a known allergy or sensitivity to any biological medicine, or to teplizumab (the study drug) or any of its ingredients
• People with a current or past history of tuberculosis (TB), or a positive TB screening test result
• People who show signs of an active Epstein-Barr virus (EBV) infection, or who had glandular fever within 3 months before enrolling
• People who show signs of an active cytomegalovirus (CMV) infection at the time of screening
• People with a history of serious internal infections such as histoplasmosis, candidiasis, aspergillosis, or similar conditions, even if they recovered
• People with other autoimmune diseases, except for stable autoimmune thyroid disease or coeliac disease
• People who have had a cancer diagnosis within the past 5 years (with some limited exceptions for certain treated skin cancers or cervical changes — confirm with trial site)
• People who have had a fever within 48 hours before joining, or who have ongoing or recurring infections requiring antibiotic, antiviral, or antifungal treatment within the past 4 weeks
• Female participants who are pregnant or breastfeeding
• People who have received a live vaccine within 8 weeks before joining, or who plan to receive one within 54 weeks after joining; or who have had a non-live vaccine within 2 weeks before joining, or plan to receive one within 8 weeks after joining
• People currently taking or who have recently taken (within 30 days) medications known to significantly affect the immune system or the course of Type 1 Diabetes, including high-dose or systemic steroids
• People currently taking or who have recently taken (within 30 days) medications known to significantly affect blood sugar levels, such as anti-diabetic drugs or certain other medicines
• People who have previously received any anti-CD3 antibody treatment, including teplizumab
• People who have received any biological therapy within 6 months before joining, or within five half-lives of that therapy (whichever is longer), or who plan to receive biological therapy within 6 weeks after joining
• People who are currently in an exclusion period from another clinical trial or who have recently received an experimental drug (within 4 months, or 3 months for an approved drug)
• People whose blood test results before joining show low levels of certain blood cells (lymphocytes, neutrophils, or platelets) or low haemoglobin (confirm specific thresholds with trial site)
• People whose liver function blood tests show results significantly above the normal range before joining (confirm specific thresholds with trial site)
• People who test positive for hepatitis B, hepatitis C, HIV, or SARS-CoV-2
• People who are allergic to or cannot take both anti-inflammatory pain medicines (NSAIDs) and paracetamol, as well as antihistamines
• People the trial doctor considers unsuitable for any medical or other reason

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