Type One DiabetesPhase 1/2NCT01881958
The Safety and Efficacy of Administrating DiaPep277® Vaccination in Type 1 Diabetes Patients.
A Phase 1/2 study testing DiaPep277® in people with Type One Diabetes, run by Hadassah Medical Organization.
Trial summary
Type 1 diabetes is caused by an autoimmune process resulting in a selective destruction of the pancreatic insulin-secreting beta-cell. DiaPep277® is a small, lyophilized powder containing 24 Amino-acids. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Type One Diabetes
- What is being tested?
- DiaPep277®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2017
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fasting C-peptide levels >= 0.2nmol/L.
- Diagnosis of type 1 diabetes
- No pregnancies or planned pregnancies of female subjects
Who cannot join
- The subject has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the Investigator, are likely to affect the subject's response to treatment or the ability to complete the study.
- The subject has a history of any kind of malignant tumor (not including basal cell skin cancer).
- The subject has clinical evidence of any diabetes-related complication that in the opinion of the Investigator would interfere with the subject's participation in and/or completion of the study.
- Subject has history of endogenous allergic reactivity:
- Severe allergic reaction or severe exacerbation of allergic asthma within 12 months prior to the Screening-Ext Visit.
- Ongoing systemic asthma treatment.
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- Subjects with history of life threatening or severe allergy, re-occurrence of which cannot be ruled out based on the Investigator's judgment.
- The subject has known allergy to lipid emulsions.
- The subject has a known immune deficiency from any disease, or a condition associated with an immune deficiency.
- The subject is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy or any medication that in the opinion of the Investigator might interfere with the study.
- The subject has any of the following clinically significant laboratory abnormalities:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of the normal (ULN) at the Screening-Ext Visit.
- Total bilirubin greater than 1.3 times the ULN at the Screening-Ext Visit.
- Subjects with severe renal failure at the Screening-Ext visit (as defined by glomerular filtration rate < 30 mL/min/1.73 m2 by Cockroft und Gault calculation • Clinically significant laboratory abnormalities, confirmed by repeat measurement, which may interfere with the assessment of safety and / or efficacy of the study drug, other than hyperglycemia and glycosuria at the Screening-Ext Visit.
- Fasting triglycerides <1000 mg/dL (11.3 mmol/L) at the Screening-Ext Visit. Suitable medical therapy for treatment of hyperlipidemia is allowed.
- The subject is a known or suspected drug abuser.
- The subject is known to test positive for HIV antibodies.
- The subject has chronic hematologic disease.
- The subject has liver disease such as cirrhosis or chronic active hepatitis.
About this study
Type 1 diabetes is caused by an autoimmune process resulting in a selective destruction of the pancreatic insulin-secreting beta-cell. DiaPep277® is a small, lyophilized powder containing 24 Amino-acids. We have proved in former studies that DiaPep277® can slow down beta cells destruction in the pancreas and therefore decelerate the progress of Diabetes.
The objective of the study is to assess the efficacy and safety of administrating DiaPep277® in type 1 diabetes patients.
- Conditions
- Type One Diabetes
- Being tested
- DiaPep277®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaPep277®Drug
| Study group | Role | What they receive |
|---|---|---|
| DiaPep277® | Experimental | Not described Receives: Drug: DiaPep277® |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy will be measured by comparing Hemoglobin A1c
Measured: two years
Secondary outcomes (1)
Safety will be evaluated calculating number of Adverse Events.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJan 2015 (estimated)
- Primary completionJan 2016 (estimated)
- Study completionJan 2017 (estimated)
Why it stopped: the manufacturer decided to halt manufacturing the vaccine
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type One DiabetesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881958
- Sponsor's protocol ID
- 0224-13-HMO-CTIL
- Status last verified
- Mar 2018
- First submitted
- 18 Jun 2013
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Administrating DiaPep277® Vaccination in Type 1 Diabetes Patients.
- ClinicalTrials.gov ID
- NCT01881958
- Acronym / sponsor ID
- 0224-13-HMO-CTIL
- Conditions
- Type One Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the manufacturer decided to halt manufacturing the vaccine
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2015 (estimated)
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 20 Jun 2013 (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.
Type 1 diabetes is caused by an autoimmune process resulting in a selective destruction of the pancreatic insulin-secreting beta-cell. DiaPep277® is a small, lyophilized powder containing 24 Amino-acids. We have proved in former studies that DiaPep277® can slow down beta cells destruction in the pancreas and therefore decelerate the progress of Diabetes.
The objective of the study is to assess the efficacy and safety of administrating DiaPep277® in type 1 diabetes patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DiaPep277® | Experimental | Drug: DiaPep277® |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fasting C-peptide levels >= 0.2nmol/L.
- Diagnosis of type 1 diabetes
- No pregnancies or planned pregnancies of female subjects
Key exclusion criteria (19 listed)
- The subject has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the Investigator, are likely to affect the subject's response to treatment or the ability to complete the study.
- The subject has a history of any kind of malignant tumor (not including basal cell skin cancer).
- The subject has clinical evidence of any diabetes-related complication that in the opinion of the Investigator would interfere with the subject's participation in and/or completion of the study.
- Subject has history of endogenous allergic reactivity:
- The subject has known allergy to lipid emulsions.
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 |
|---|---|---|
| DiaPep277® | Drug | DiaPep277® |
Primary outcome
efficacy will be measured by comparing Hemoglobin A1c
Time frame: two years
1 secondary outcome
Safety will be evaluated calculating number of Adverse Events.
Time frame: two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DiaPep277® in people with Type One Diabetes, run by Hadassah Medical Organization.
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 3 inclusion and 19 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: withdrawn, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
efficacy will be measured by comparing Hemoglobin A1c (time frame: two 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 6 Mar 2018.