Effects of Sitagliptin in Relatives of T1D Patients (SITA-one)

This is an interventional prevention trial for Type 1 Diabetes focused on measuring Sitagliptin Read More

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.