Status:
NOT_YET_RECRUITING
Effects of Sitagliptin in Relatives of T1D Patients
Lead Sponsor:
University of Milan
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
10-45 years
Phase:
PHASE2
PHASE3
Brief Summary
Type 1 Diabetes (T1D) is a chronic autoimmune disease, with a genetic background, resulting from the immune-mediated destruction of beta cells of the pancreas. It can lead to fatal short-term and long...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05219409
Start Date
July 1 2023
End Date
December 1 2027
Last Update
May 10 2023
Active Locations (1)
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1
ASST FBF Sacco
Milan, Italy, 20157