Monotherapy With Rapamycin in Long-standing Type 1 Diabetes
Status:
Completed
Trial end date:
2019-03-01
Target enrollment:
Participant gender:
Summary
This study is a phase 2, single-center, prospective, randomized, double-blind,
placebo-controlled, 3-arm parallel group (1:1:1) intervention trial to determine the efficacy
of 4 weeks rapamycin treatment and 4 weeks rapamycin treatment plus 3 months vildagliptin
treatment versus placebo in increasing endogenous insulin production and correcting glycemic
lability. It will involve 60 patients with long standing type 1 diabetes (T1D). Patients will
receive for one month placebo (Group 1), rapamycin plus placebo (Group 2), or rapamycin plus
Vildagliptin (Group 3). Rapamycin will be administered at an initial dose 0.2 mg/kg orally on
day 0 followed by 0.1 mg/kg/die (target trough levels: 8-10 ng/ml). Vildagliptin will be
administered at a dose of 50 mg x2/die starting from day 0. After 4 weeks of treatment
(period A), patients will discontinue rapamycin or relevant placebo treatment, but continue
Vildagliptin or placebo for a further 8 weeks and be monitored over this period (period B).
Phase:
Phase 2
Details
Lead Sponsor:
Piemonti Lorenzo
Collaborators:
Fondazione Italiana Diabete Onlus Italian Diabetes Foundation
Treatments:
Dipeptidyl-Peptidase IV Inhibitors Everolimus Sirolimus Vildagliptin