Clinical study in patients who have completed study 1001, to look at the long term effect and safety of DiaPep277.

Conditions: Type I diabetes
MedDRA version: 16.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2013-002775-17-ES

Lead Sponsor: Andromeda Biotech Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 281

Inclusion Criteria

1. A patient who completed the 1001 study. Subjects who have completed 1001 study with a minimum of 80% compliance to the drug injections (8 study drug injections) may be selected. Female patients who interrupted the study drug injections because of a pregnancy, but were otherwise compliant to all the study requirements, or male subjects who may have missed a visit and/or an administration of study drug, may be considered for inclusion on a case by case basis, at the discretion of the investigator.
2. Evidence of clinically significant residual beta-cell function demonstrated by GST stimulated C-peptide concentrations ? 0.20nmol/l.
3. If a female is of childbearing potential, the subject must not be pregnant or lactating, and must agree to use oral hormonal contraception or other equally effective contraceptive methods throughout the study.
4. Stable medical condition for diseases, other than diabetes, during 30 days before the Screening-Ext Visit.
5. Signed informed consent to participate in the study
6. Ability to comply with all study requirements.
7. The subject is compliant to the implementation of intensive insulin therapy (basal / bolus insulin) in the opinion of the investigator or is willing to initiate intensive insulin therapy, or is using an insulin pump. Patients on conventional insulin regime who maintained HbA1c ?7% over the last 6 months can be recruited without switching to intensive insulin regime.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 281
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The subject has any significant ongoing 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 their ability to complete the study.
2. The subject has a history of any kind of malignant tumor (not including basal cell skin cancer or adequately treated in situ carcinoma of the cervix).
3. 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.
4. Subject has history of endogenous allergic reactivity:
a. Severe allergic reaction or severe exacerbation of allergic asthma within 12 months prior to the Screening-Ext Visit.
b. Ongoing systemic parenteral or oral steroids for asthma treatment.
c. 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.
5. The subject has a known immune deficiency from any disease, or a condition associated with an immune deficiency.
6. 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.
7. The subject has any of the following clinically significant laboratory abnormalities:
a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of the normal (ULN) at the Screening-Ext Visit.
b. Total bilirubin greater than 1.3 times the ULN at the Screening-Ext Visit.
c. Subjects with severe renal failure at the Screening-Ext visit (as defined by glomerular filtration rate < 30 mL/min/1.73 m2 by Cockroft and Gault calculation (13) or by Kidney Disease Epidemiology Collaboration (CKD-EPI) calculation (14))
d. 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.
e. Fasting triglycerides >1000 mg/dl (11.3 mmol/l) at the Screening-Ext Visit. Suitable medical therapy for treatment of hyperlipidemia is allowed.
8. The subject is a known or suspected drug abuser.
9. The subject is known to test positive for HIV antibodies.
10. The subject has chronic hematologic disease.
11. The subject has liver disease such as cirrhosis or chronic active hepatitis.
12. The subject has received any investigational drug within 3 months prior to Visit 12, other than DiaPep277 and/or placebo which were administered during study 1001.
13. The subject has had a severe blood loss (? 400 ml, e.g., blood donation) within 2 months before the first dose of the study medication.
For forbidden prior and concomitant medications/treatments please refer to section 7.2. of the protocol