Type 1 DiabetesPhase 1/2MonoPepT1DeNCT01536431
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
A Phase 1/2 study testing Pro insulin peptide and Saline in people with Type 1 Diabetes, run by Cardiff University at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Pro insulin peptide and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Jan 2012to Feb 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 17Show fewer
- 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)).
- Peak insulin C-peptide >200 pmol/L (at any time point after stimulation with Mixed Meal Tolerance Test).
- Written and witnessed informed consent to participate.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Bristol Royal Infirmary
Bristol
University Hospital of Wales
Cardiff
Countess of Chester
Chester, England, CH2 1UL
Guy's Hospital
London
Royal Victoria Hospital
Newcastle
About this study
Official title: Phase 1b Study of Proinsulin (PI) Peptide Immunotherapy in New-Onset Type 1 Diabetes
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.
Read the detailed description
Type 1 Diabetes (also known as insulin-dependent diabetes) is caused by destruction of the insulin producing cells (Beta Cells) in the pancreas. Our group is interested in how this destruction could be stopped or reversed, as this may lead to development of a new generation of diabetes treatments which can prevent or slow down the damage, reducing or possibly even removing there need for insulin injections.
In a previous study we examined the safety of our novel approach to this problem, proinsulin (PI) peptide immunotherapy, in longstanding diabetes patients (diagnosed more than 5 years before), and found it to be well tolerated and free of major hypersensitivity reactions. However, it remains theoretically possible that this form of immunotherapy could make the immune reaction to the insulin making cells worse rather than better.
This cannot be studied directly in longstanding patients as they have no or almost no insulin making cells left.
So,the principle objective of the current 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Pro insulin peptide, Saline
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro insulin peptideDrug
Patients will receive 10 micro gr of the peptide every 2 weeks (12 doses).
Pro insulin peptideDrug
Patients 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).
SalineDrug
Patients will receive 0 micro gr of peptide, but have saline injections every 2 weeks (controls).
| Study group | Role | What they receive |
|---|---|---|
| Pro insulin peptide | Experimental | Patients will receive 10 micro gr of the peptide every 2 weeks (12 doses). Receives: Drug: Pro insulin peptide |
| Pro insulin peptide & saline | Active comparator | Patients 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). Receives: Drug: Pro insulin peptide |
| Saline | Placebo comparator | Patients will receive 0 micro gr of peptide, but have saline injections every 2 weeks (controls) Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Vaccine Development Centre, Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Professor Colin Dayan, Cardiff University
- Investigators
- Mark Peakman, MBBS BSc MSc PhD FRCP, Study director, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536431
- Sponsor's protocol ID
- SPON817-10
- Other IDs
- 2007-003759-35, 66760879
- Acronym
- MonoPepT1De
- Status last verified
- Jul 2015
- First submitted
- 14 Feb 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study of Proinsulin (PI) Peptide Immunotherapy in New-Onset Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01536431
- Acronym / sponsor ID
- MonoPepT1De / SPON817-10
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Collaborators
- Diabetes Vaccine Development Centre, Juvenile Diabetes Research Foundation
- Study start
- Jan 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 1 Diabetes (also known as insulin-dependent diabetes) is caused by destruction of the insulin producing cells (Beta Cells) in the pancreas. Our group is interested in how this destruction could be stopped or reversed, as this may lead to development of a new generation of diabetes treatments which can prevent or slow down the damage, reducing or possibly even removing there need for insulin injections.
In a previous study we examined the safety of our novel approach to this problem, proinsulin (PI) peptide immunotherapy, in longstanding diabetes patients (diagnosed more than 5 years before), and found it to be well tolerated and free of major hypersensitivity reactions. However, it remains theoretically possible that this form of immunotherapy could make the immune reaction to the insulin making cells worse rather than better.
This cannot be studied directly in longstanding patients as they have no or almost no insulin making cells left.
So,the principle objective of the current 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pro insulin peptide | Experimental | Drug: Pro insulin peptidePatients will receive 10 micro gr of the peptide every 2 weeks (12 doses). |
| Pro insulin peptide & saline | Active comparator | Drug: Pro insulin peptidePatients 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 comparator | Drug: SalinePatients will receive 0 micro gr of peptide, but have saline injections every 2 weeks (controls) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Age 18-40 years.
- If female, must be (as documented in patient notes):
- If male, must be:
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pro insulin peptidePatients will receive 10 micro gr of the peptide every 2 weeks (12 doses). | Drug | Pro insulin peptide |
| Pro insulin peptidePatients 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). | Drug | Pro insulin peptide & saline |
| SalinePatients will receive 0 micro gr of peptide, but have saline injections every 2 weeks (controls). | Drug | Saline |
Primary outcome
Safety
Time frame: 3 years
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.
4 secondary outcomes
Allergy and hypersensitivity
Time frame: 3 years
Safety of frequent dosing
Time frame: 3 years
Protective effects of insulin preservation
Time frame: 3 years
T cell (immune) response to islet cell antigens
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Peakman, MBBS BSc MSc PhD FRCP study director
King's College Hospital NHS Trust
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pro insulin peptide and Saline in people with Type 1 Diabetes, run by Cardiff University at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.