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
MonoPepT1De
Phase 1b Study of Proinsulin (PI) Peptide Immunotherapy in New-Onset Type 1 Diabetes
3 other identifiers
interventional
27
1 country
5
Brief Summary
The purpose of this study is 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2012
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 14, 2012
CompletedFirst Posted
Study publicly available on registry
February 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJuly 28, 2015
July 1, 2015
3.1 years
February 14, 2012
July 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Allergy and hypersensitivity
3 years
Safety of frequent dosing
3 years
Protective effects of insulin preservation
3 years
T cell (immune) response to islet cell antigens
3 years
Study Arms (3)
Pro insulin peptide
EXPERIMENTALPatients will receive 10 micro gr of the peptide every 2 weeks (12 doses).
Pro insulin peptide & saline
ACTIVE COMPARATORPatients will receive 10 micro gr of the peptide monthly (ever 4 weeks, 6 doses) and saline injections monthly alternating with the peptide (2 weeks interval between the drug and saline).
Saline
PLACEBO COMPARATORPatients will receive 0 micro gr of peptide, but have saline injections every 2 weeks (controls)
Interventions
Patients will receive 10 micro gr of the peptide every 2 weeks (12 doses).
Patients will receive 0 micro gr of peptide, but have saline injections every 2 weeks (controls).
Eligibility Criteria
You may qualify if:
- Age 18-40 years.
- If female, must be (as documented in patient notes):
- postmenopausal (at least 1 year without spontaneous menses)
- surgically sterile (tubal ligation or hysterectomy at least 6 months prior to enrolment)
- using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception) at least 3 months prior to enrolment
- have a sexual partner with non-reversed vasectomy (with confirmed azoospermia)
- be using 1 barrier method with the use of a spermicide(e.g., condom, diaphragm or cap)
- have placement of a intra-uterine device
- If male, must be:
- using a barrier method of contraception (condom) with the use of a spermicide
- have a sexual partner using one of the methods in point 2 above or
- have a non-reversed vasectomy (with confirmed azoospermia),
- Diagnosis of Type 1 diabetes within the last 100 days (dated from the first insulin injection).
- Possession of \*0401 allele at the HLA-DRB1 gene locus
- At least one positive islet cell autoantibody (ie anti-GAD65, antibodies to insulinoma-associated antigen-2 (IA-2) or zinc transporter 8 (ZnT8)).
- +2 more criteria
You may not qualify if:
- Females who are pregnant, breast-feeding or not using adequate forms of contraception.
- Use of immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to randomisation and any monoclonal antibody therapy given for any indication.
- Any other medical condition which, in the opinion of investigators, could affect the safety of the subject's participation.
- Recent subject's involvement in other research studies which, in the opinion of investigators, may adversely affect the safety of the subjects or the results of the study.
- Subjects should not have had immunisations with live or killed vaccines or allergic desensitisation procedures less than 1 month prior to their first treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardiff Universitylead
- Diabetes Vaccine Development Centrecollaborator
- Juvenile Diabetes Research Foundationcollaborator
Study Sites (5)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Peakman, MBBS BSc MSc PhD FRCP
King's College Hospital NHS Trust
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 14, 2012
First Posted
February 22, 2012
Study Start
January 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
July 28, 2015
Record last verified: 2015-07