| Trial ID: | L3076 |
| Source ID: | NCT02586831
|
| Associated Drug: |
Anti-Thymocyte Globulin (Atg)
|
| Title: |
Diabetes Islet Preservation Immune Treatment
|
| Acronym: |
DIPIT
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1|Hypoglycemia|Autoimmune Diseases|Diabetes Mellitus
|
| Interventions: |
DRUG: Anti-Thymocyte Globulin (ATG)|DRUG: Interleukin 2|DRUG: Exenatide|DRUG: Adalimumab|OTHER: ATG Placebo|OTHER: IL-2 Placebo|OTHER: Adalimumab Placebo|OTHER: Exenatide Placebo
|
| Outcome Measures: |
Primary: Simulated C-peptide AUC, Endogenous insulin secretion as measured as stimulated C-peptide section Area Under the Curve (AUC) during a 4 hour mixed meal tolerance test (MMTT), 1 Year Visit|Proportion of regulatory T cells, As measured from blood samples, 1 Year Visit | Secondary: Hemoglobin A1c (HbA1c) levels, Measure of glycemic control as evaluated by HbA1c levels from blood samples, Up to 18 months|Insulin dose, Measure of glycemic control as evaluated by insulin dose, Up to 18 months|Mean daily plasma glucose levels, Measure of glycemic control as evaluated by the mean daily plasma glucose levels from blood samples, Up to 18 months|Incidence of immune response adverse events, Incidence of immune response adverse events as assessed by treating physician, Up to 18 months
|
| Sponsor/Collaborators: |
Sponsor: Camillo Ricordi and Jay Skyler | Collaborators: Diabetes Research Institute Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2025-01
|
| Completion Date: |
2029-12
|
| Results First Posted: |
|
| Last Update Posted: |
2024-06-06
|
| Locations: |
Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, Florida, 33136, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02586831
|
