| Trial ID: | L2714 |
| Source ID: | NCT01762644
|
| Associated Drug: |
Oral Cyclosporine And Oral Omeprazole
|
| Title: |
The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Omeprazole for Insulin Independence Among Recent Onset Type 1 Diabetes Patients
|
| Acronym: |
IIT
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Oral Cyclosporine and Oral Omeprazole|DRUG: Oral Omeprazole
|
| Outcome Measures: |
Primary: Insulin Independence and Hemoglobin A1c (A1C) < 6.5%, 24 weeks | Secondary: Safety and tolerability, 24 weeks|Pancreatic beta cell function measured by glucagon stimulated C-peptide response, 24 weeks|Proportion of participants achieving insulin independence, 24 weeks|Blood glucose control measured by A1C, 24 weeks|Average daily insulin requirement per week, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Perle Bioscience, Inc. | Collaborators: Syreon Corporation
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-08
|
| Completion Date: |
2016-08
|
| Results First Posted: |
|
| Last Update Posted: |
2016-04-18
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01762644
|
