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Clinical Trial Details

Trial ID: L2638
Source ID: NCT02803892
Associated Drug: Rapamycin
Title: Monotherapy With Rapamycin in Long-standing Type 1 Diabetes
Acronym: MONORAPA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: rapamycin|DRUG: Vildagliptin|DRUG: Placebo 1|DRUG: Placebo 2
Outcome Measures: Primary: Change from Baseline C-peptide response in the MMTT, the proportion of participants with a positive response to the MMTT defined as C-peptide at 90 min \>0.6 ng/ml., week 4±1, week 12±2|Change from Baseline C-peptide after the MMTT, change in the area under the curve of C-peptide after the MMTT vs baseline, week 4±1, week 12±2 | Secondary: Change from Baseline insulin requirement, change in insulin requirement vs baseline, week 4±1, week 12±2|Change from Baseline fasting C-peptide, change in fasting C-peptide vs baseline, week 4±1, week 12±2|Change from Baseline HbA1c, change in HbA1c vs baseline, week 4±1, week 12±2|Adverse Events (AEs) related to the immunosuppression, the incidence and severity of Adverse Events (AEs) related to the immunosuppressive treatment, week 4±1, week 12±2|Adverse Events (AEs) and Serious Adverse Events (SAEs), Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs), week 4±1, week 12±2
Sponsor/Collaborators: Sponsor: Piemonti Lorenzo | Collaborators: Italian Diabetes Foundation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 55
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2016-05
Completion Date: 2019-03
Results First Posted:
Last Update Posted: 2020-11-04
Locations: IRCCS San Raffaele Scientific Institute, Milan, 20132, Italy
URL: https://clinicaltrials.gov/show/NCT02803892