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Type 1 DiabetesPhase 3NCT01460251

OPen Label Study to Evaluate Long Term Treatment Effect of DiaPep277

A Phase 3 study testing DiaPep277 in people with Type 1 Diabetes, run by Rabin Medical Center at 2 sites in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study is an open-label extension study, offering patients who participated and completed previous studies 901 and 910 (an extension to 901) to continue treatment with DiaPep277 and clinical follow-up, for up to 3 additional years.The aim of the study is to collect safety and efficacy data of long term treatment… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
DiaPep277
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
2 sitesIsrael
Study dates
Jan 2012to Feb 2015
Phase
Phase 3
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • A patient that participated in Study 901 and received all doses of study medication, per protocol or Study 910 and received all doses of study medication, per protocol.
  • Evidence of clinically significant residual beta-cell function demonstrated by MMTT stimulated C-peptide concentrations ≥ 0.20 nmol/L.
  • If a female is of childbearing potential, the subject is not pregnant or lactating, and will use oral hormonal contraception or other equally effective contraceptive methods throughout the study.
  • Stable medical condition for diseases, other than diabetes, during 30 days before the Screening Ext Visit.
  • Signed informed consent to participate in the study
  • The subject is on intensive insulin therapy (basis / bolus insulin) or is willing to initiate intensive insulin therapy, or is using an insulin pump. Patients on conventional insulin regime that had HbA1c<7% over the last 6 months can be recruited without switching to intensive insulin regime.

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
  • 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.
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  • 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 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.
  • The subject has received any investigational drug within 3 months prior to Visit 12, other than DiaPep277 that was administered during study 901 or 910.
  • The subject has had a severe blood loss within 2 months before the first dose of the study medication.

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

  • Hadassah Medical Center

    Jerusalem, 91120

  • Schneider Children's Medical Center

    Petah Tikva, 49202

Other trials in Israel

About this study

Official title: OPen Label Study to Evaluate Long Term Treatment Effect of DiaPep277 in Patients Who Have Completed Study 901 and Study 910 (Extension to 901 Phase III Study

The study is an open-label extension study, offering patients who participated and completed previous studies 901 and 910 (an extension to 901) to continue treatment with DiaPep277 and clinical follow-up, for up to 3 additional years.The aim of the study is to collect safety and efficacy data of long term treatment effect of Diapep277.Only patients who completed studies 901 or 910 and still have stimulated C-peptide level equal to or above 0.2 nmol/L will be eligible for this extension study

Read the detailed description

The study is an open-label extension study, offering patients who participated and completed previous studies 901 and 910 (an extension to 901) to continue treatment with DiaPep277 and clinical follow-up, for up to 2 additional years.The aim of the study is to collect safety and efficacy data of long term treatment effect of Diapep277.Only patients who completed studies 901 or 910 and still have stimulated C-peptide level equal to or above 0.2 nmol/L will be eligible for this extension study. The optimal dose and dosing regimen for this study will be the same as applied in the phase 3 study (901) and its extension study protocol (910), namely 1.0 mg DiaPep277® administered every 3 months. These conditions were determined as optimal based on the outcome of the phase 2 studies. For patients who just completed the 2-year 901 study, a 3-year extended treatment will be offered with 13 administrations; patients who completed the 2-year 910 extension study will be offered a 3rd year of treatment with 5 additional administrations.

Conditions
Type 1 Diabetes
Being tested
DiaPep277
Keywords
type 1 diabetes, beta cell, immunomodulation, immunointervention
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiaPep277Drug

    1.0 mg DiaPep277® administered every 3 months.For patients who just completed the 2-year 901 study, a 3-year extended treatment will be offered with 13 administrations; patients who completed the 2-year 910 extension study will be offered a 3rd year of treatment with 5 additional administrations.

Study groups in NCT01460251
Study groupRoleWhat they receive
Drug:Diapep277Experimental1.0 mg DiaPep277® administered every 3 months.For patients who just completed the 2-year 901 study, a 3-year extended treatment will be offered with 13 administrations; patients who completed the 2-year 910 extension study will be offered a 3rd year of treatment with 5 additional administrations.
Receives: Drug: DiaPep277

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Measured: month 38

  2. DiaPep277-specific antibodies

    Measured: month 38

Secondary outcomes (4)

  1. Beta cell function-AUC of stimulated C-peptide from stimulated MMTT measured by radioimmunoassay

    Measured: month 38

  2. Percentage of patients that maintain stimulated C-peptide >/= 0.2nmol/L

    Measured: month 38

  3. percentage of patients that achieve glycemic target of HbA1c</=7%

    Measured: month 38

  4. Daily insulin dose adjusted to body weight at study end

    Measured: month 38

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2014
  4. Study completionFeb 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01460251
Sponsor's protocol ID
rmc006492ctil
Status last verified
Jul 2014
First submitted
6 Oct 2011
Last updated
19 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DiaPep277 in people with Type 1 Diabetes, run by Rabin Medical Center at 2 sites in Israel.

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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 stopped early. Results are not available in the source record.

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?

Adverse events (time frame: month 38). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01460251.

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 19 Mar 2015.

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