| Trial ID: | L6191 |
| Source ID: | NCT05219409
|
| Associated Drug: |
Sitagliptin
|
| Title: |
Effects of Sitagliptin in Relatives of T1D Patients
|
| Acronym: |
SITA-one
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Sitagliptin|DEVICE: Professional CGM
|
| Outcome Measures: |
Primary: Rate of new diagnoses of Type 1 Diabetes Mellitus per year, 3 years | Secondary: Number of participants with adverse effects on Sitagliptin, 3 years | Other: To study the effects of Sitagliptin on metabolic markers (C-peptide, OGTT, Insulin) over time up to the diagnosis of diabetes, 3 years|To study the prevalence of T1D, T1D-related Auto-antibodies and Dysglycemia in relatives of T1D patients, 3 years|Monitor Stage 2 patients with a CGM system (continuous blood glucose detection), 3 years
|
| Sponsor/Collaborators: |
Sponsor: University of Milan
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
70
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2023-07
|
| Completion Date: |
2027-12
|
| Results First Posted: |
|
| Last Update Posted: |
2023-05-10
|
| Locations: |
ASST FBF Sacco, Milan, 20157, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT05219409
|
