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TerminatedNCT01460251Updated Mar 19, 2015

OPen Label Study to Evaluate Long Term Treatment Effect of DiaPep277

A Phase 3 interventional study of DiaPep277 in Type 1 Diabetes, sponsored by Rabin Medical Center. Terminated at 2 sites in Israel. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-03-19.

Sponsored by Rabin Medical Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • type 1 diabetes
  • beta cell
  • immunomodulation
  • immunointervention
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 11 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Drug:Diapep277

    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.

    Drug: DiaPep277

Interventions

  • 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.

06

What researchers measure

Primary outcomes

  1. Adverse events

    Time frame: month 38

  2. DiaPep277-specific antibodies

    Time frame: month 38

Secondary outcomes

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

    Time frame: month 38

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

    Time frame: month 38

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

    Time frame: month 38

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

    Time frame: month 38

07

Study locations

2 sites
  • Hadassah Medical Center
    Jerusalem, 91120, Israel
  • Schneider Children's Medical Center
    Petah Tikva, 49202, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01460251
Responsible party
Sponsor
First posted
Oct 26, 2011
Start date
Jan 2012
Primary completion
Dec 2014
Completion
Feb 2015
Last update
Mar 19, 2015

Study contacts

Liat de Vries, Dr
principal investigator · Rabin Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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