| Trial ID: | L2084 |
| Source ID: | NCT01536431
|
| Associated Drug: |
Pro Insulin Peptide
|
| Title: |
Safety Study to Assess Whether Proinsulin Peptide Injections Can Slow or Stop the Body Damaging Its Own Insulin-making Cells in the Pancreas in Patients Newly Diagnosed With Type 1 Diabetes
|
| Acronym: |
MonoPepT1De
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Pro insulin peptide|DRUG: Pro insulin peptide|DRUG: Saline
|
| Outcome Measures: |
Primary: Safety, To address the safety issue of whether, in patients with newly-diagnosed diabetes who still make some insulin, proinsulin peptide therapy adversely affects the rate of damage to the insulin making cells., 3 years | Secondary: Allergy and hypersensitivity, To confirm that PI peptide treatment does not induce allergy or hypersensitivity and has a good safety profile in new-onset type 1 diabetes patients., 3 years|Safety of frequent dosing, To explore the safety of extending peptide treatment to more frequent dosing (2-weekly) and for a longer time period (6 months), 3 years|Protective effects of insulin preservation, To provide preliminary data on any protective effect on preservation of insulin production after 1 year of treatment, 3 years|T cell (immune) response to islet cell antigens, To provide preliminary data on changes in the T cell (immune) response to islet cell antigens in newly-diagnosed patients following PI peptide treatment., 3 years
|
| Sponsor/Collaborators: |
Sponsor: Cardiff University | Collaborators: Diabetes Vaccine Development Centre|Juvenile Diabetes Research Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
27
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-01
|
| Completion Date: |
2015-02
|
| Results First Posted: |
|
| Last Update Posted: |
2015-07-28
|
| Locations: |
Countess of Chester, Chester, England, CH2 1UL, United Kingdom|Bristol Royal Infirmary, Bristol, United Kingdom|University Hospital of Wales, Cardiff, United Kingdom|Guy's Hospital, London, United Kingdom|Royal Victoria Hospital, Newcastle, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT01536431
|
