| Trial ID: | L2983 |
| Source ID: | NCT03624062
|
| Associated Drug: |
Mas-1 Adjuvanted Insulin B-Chain
|
| Title: |
MER3101: MAS-1 Adjuvanted Antigen-specific Immunotherapeutic for Prevention and Treatment of Type 1 Diabetes
|
| Acronym: |
MER3101
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: MAS-1 adjuvanted Insulin B-chain
|
| Outcome Measures: |
Primary: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Number of participants with Treatment-Related Adverse Events, and the frequency of Adverse Events, as Assessed by CTCAE v4.0. The rates of severe hypoglycemic and adverse events will be computed (total number of events divided by total patient years of follow-up) and the rates compared using a Poisson regression model., 43 months|Immunologic Analysis, T cell assays looking for IL-4, IL-5, IL-10, IL-13, TGFβ production and shift towards Treg and iNKT cell population., 43 months | Secondary: Mean C-peptide AUC value, The area under the stimulated C-peptide curve (AUC) over the first 2 hours of a mixed meal glucose tolerance test. The AUC is computed using the trapezoidal rule that is a weighted sum of the C-peptide values over the 120 minutes., 43 months|HbA1c value, The mean HbA1c over all follow-up values will be compared between the control and placebo group using a normal errors longitudinal analysis., 43 months|Insulin Use, The mean insulin dose (units/kg) over all follow-up values will be compared between the control and placebo group using a normal errors longitudinal analysis., 43 months
|
| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver | Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust|Nova Immunotherapeutics Limited
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
28
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-08-31
|
| Completion Date: |
2025-12-10
|
| Results First Posted: |
|
| Last Update Posted: |
2024-10-01
|
| Locations: |
University of Colorado, Denver, Aurora, Colorado, 80045, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03624062
|
