The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Patients With Existing Type 1 Diabetes

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

September 30, 2014

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions
Type 1 Diabetes
Interventions
DRUG

Oral Cyclosporine and Oral Lansoprazole

Oral Cyclosporine A dosed at 7.5 mg/kg/day and Oral Lansoprazole dosed at 30 mg in two divided dosages to subjects ages 8-15 and 60 60 mg in divided dosages to subjects ages 16-60. The Cyclosporine A and Lansoprazole may be given as an oral tablet/capsule or oral suspension.

DRUG

Placebos

Two oral placebos are given at breakfast and dinner. The placebos may be given as an oral tablets/capsules or oral suspensions.

Sponsors
All Listed Sponsors
lead

Perle Bioscience, Inc.

INDUSTRY