Clinical Research Directory

Inclusion Criteria: * Age of the subject between 10 and 45 years * Subject (or legal guardian in the case of a minor) is able to provide informed consent * If a first degree relative of the proband with T1D must be between 6 and 45 years old (brother, sister, parent, child) * If a relative of the proband with T1D is second degree, he must be between 6 and 20 years old (nephew, uncle, aunt, grandfather, grandmother, cousin) * Presence of at least two autoantibodies associated with diabetes * Impaired glucose tolerance on the OGTT test (fasting glucose greater than 110 mg/dl but less than 126 mg/dl or 2-hour glucose greater than or equal to 140 mg/dl but less than 200 mg/dl or 'OGTT at 30', 60 ', 90' greater than or equal to 200 mg/dl) * If the subject is a female with reproductive potential, she must have a negative pregnancy test at the enrollment visit and must agree not to seek pregnancy for at least one year from randomization * If the subject is male, he must agree not to seek pregnancies with any partner for at least one year from the randomization * The subject must agree to renounce other types of trials during this study * Weight at the time of recruitment of at least 26 kg * It must be favorable and clinically acceptable to postpone vaccinations with live and attenuated agents for at least one year after treatment Exclusion Criteria: * Type 1 Diabetes Mellitus previously diagnosed or diagnosed during screening investigations * Serological evidence of current or past HIV, Hepatitis C, Hepatitis B * Changes in blood counts, INR or liver enzymes * Being pregnant or breastfeeding * Evidence of pancreatic changes in the laboratory * Having undergone a previous experimental treatment for Type 1 Diabetes Mellitus * Chronic Renal Failure stage IIIa onwards (eGFR \<45 ml / min / 1.7 m2) * History of previous pancreatitis * Lymphopenia (\<1000 lymphocytes / µL) * Neutropenia (\<1500 PMN / µL) * Thrombocytopenia (\<150,000 platelets / µL) * Anemia (Hgb \<10 grams / deciliter \[g / dL\]) * AST or ALT\> 1.5 x ULN * Total bilirubin\> 1.5 x upper limit of normal (ULN) with the exception of subjects diagnosed with Gilbert's syndrome who may be eligible provided they have no other cause leading to hyperbilirubinemia * INR\> 0.1 above the upper limit of the norm at the laboratory of the participating center * Alterations of Amylase and Lipase due to the pancreas * Chronic active infection other than localized skin infections * A positive PPD test * Vaccination with a live virus within 8 weeks of randomization * Vaccination with a killed virus within 4 weeks of randomization * Laboratory or clinical evidence of acute EBV or CMV infection * Serological evidence of current or past HIV, hepatitis B or hepatitis C infection * Being currently pregnant or breastfeeding, or planning to become pregnant * Chronic use of steroids or other immunosuppressive agents * A history of asthma or atopic disease that requires chronic treatment * Untreated hypothyroidism or active Graves' disease at randomization * Current use of non-insulin drugs that affect glycemic control * Previous OKT®3 or other anti-CD3 treatment * Administration of a monoclonal antibody within the year prior to randomization * Participation in any type of clinical trial of therapeutic drugs or vaccines in the 12 weeks prior to randomization * Any conditions that, in the opinion of the investigator, could interfere with the conduct of the study or with the safety of the subject.