Monotherapy With Rapamycin in Long-standing Type 1 Diabetes

PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

December 31, 2018

Study Completion Date

March 31, 2019

Conditions
Diabetes Mellitus, Type 1
Interventions
DRUG

rapamycin

Rapamycin will be administered at an initial dose 0.2 mg/kg on day 0, followed by 0.1 mg/kg/die. The daily dose will be adjusted to the whole blood 24-hr trough to target, as tolerated, 8-10 ng/mL

DRUG

Vildagliptin

Vildagliptin will be administered at a dose of 50 mg x2/die starting from day 0.

DRUG

Placebo 1

Placebo 1 will be titrated according to a random schedule alternating plausible doses of placebo. After 4 weeks of treatment patients will discontinue placebo 1

DRUG

Placebo 2

Placebo 2 will be administered BID starting from day 0. After 8 weeks of treatment patients will discontinue placebo 2

Trial Locations (1)

20132

IRCCS San Raffaele Scientific Institute, Milan

All Listed Sponsors
collaborator

Italian Diabetes Foundation

OTHER

lead

Piemonti Lorenzo

OTHER

NCT02803892 - Monotherapy With Rapamycin in Long-standing Type 1 Diabetes | Biotech Hunter | Biotech Hunter