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    Summary
    EudraCT Number:2013-002775-17
    Sponsor's Protocol Code Number:1010
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-08-20
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2013-002775-17
    A.3Full title of the trial
    OPEN-LABEL STUDY TO EVALUATE LONG TERM SAFETY AND TREATMENT EFFECT OF DIAPEP277® IN SUBJECTS WHO HAVE COMPLETED STUDY 1001
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study in patients who have completed study 1001, to look at the long term effect and safety of DiaPep277.
    A.4.1Sponsor's protocol code number1010
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01898286
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAndromeda Biotech Ltd
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAndromeda Biotech Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationinVentiv Health Clinical Spain, S.L.
    B.5.2Functional name of contact pointEleana Spanidis
    B.5.3 Address:
    B.5.3.1Street AddressPlaza de la Independencia nº2, 1 Dcha
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28001
    B.5.3.4CountrySpain
    B.5.4Telephone number+34928 351 053
    B.5.5Fax number+34914 314 495
    B.5.6E-maileleana.spanidis@inventivhealth.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDiaPep277
    D.3.2Product code DiaPep277
    D.3.4Pharmaceutical form Lyophilisate and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPO-102
    D.3.9.1CAS number 179822-83-4
    D.3.9.2Current sponsor codePO-102 Peptide
    D.3.9.3Other descriptive nameDIAPEP 277
    D.3.9.4EV Substance CodeSUB33381
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeImmunomodulatory agent - synthetic peptide
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type I diabetes
    E.1.1.1Medical condition in easily understood language
    Type1 diabetes: disorder of human immune system so that body can't produce insulin. Without insulin, the body can't convert sugar from food into nutrients for cells, later resulting in organ damage.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10045228
    E.1.2Term Type I diabetes mellitus
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Long term effect of DiaPep277® : long term safety and tolerability of quarterly treatment, and long term effect on clinical outcome and on preservation of beta-cell function in subjects with up to 4 years of total treatment.
    Major Criteria:
    • Assess the safety and tolerability of DiaPep277®
    • Assess the effect of DiaPep277® on glycemic control
    • Assess the effect of DiaPep277® on daily insulin dose/body weight at study end
    • Assess the effect of DiaPep277® on hypoglycemic events
    • Assess the effect of DiaPep277® on maintenance of partial remission
    • Assess the effect of DiaPep277® treatment on pancreatic beta-cell function as measured by stimulated C-peptide secretion after I.V. glucagon- stimulated test (GST) or a mixed-meal tolerance test (MMTT), and by fasting C-peptide level.
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy endpoints will be:
    • Assess the effect of DiaPep277® on glycemic control - HbA1c level: the percentage of patients with HbA1c ≤7%
    • Assess the effect of DiaPep277® on daily insulin dose/body weight at study end and the percentage of patients with a daily insulin dose/body weight ≤0.5 IU/day.
    • Assess the percentage of subjects with HbA1c ≤7% AND a daily insulin dose/body weight ≤0.5 IU/day (partial remission).
    • Assess the percentage of subjects in partial remission defined as IDAA1c≤9 (insulin dose-adjusted haemoglobin A1c). IDAA1c = %HbA1c + 4x daily insulin dose.
    • Assess the effect of DiaPep277® on the number of hypoglycemic events and the event rate.
    • Assess the effect of DiaPep277® on mean amplitude of glucose excursions.
    • Investigate the long term treatment effect on beta-cell function, as determined by change from Baseline-Ext in stimulated C-peptide AUC0-20 min and Cmax secretion during the Glucagon stimulation test (GST), and the AUC0-120 min and Cmax secretion during the mixed-meal test (MMTT).
    • Investigate the long term treatment effect on beta-cell function, as determined by change from Baseline-Ext in basal, fasting C-peptide secretion.
    • Assess the percentage of subjects with a maximal stimulated C-peptide level ≥ 0.2 nmol/l at each time point • Assess the percent of subjects who maintain a basal, fasting C-peptide level ≥ 0.22 nmol/l at each time point
    • Lowering the mean amplitude of post-prandial glucose excursions in subjects in the DiaPep277® group compared to the placebo group, as recorded by CGMS
    • Lowering the event rate and duration of hypoglycemic events and on the glucose AUC0-24 hours in subjects in the DiaPep277® group compared to the placebo group, as recorded by CGMS.

    Safety Endpoints
    • To determine clinical safety and tolerability of DiaPep277® during the study.
    • To determine the effect of DiaPep277® on DiaPep277®-specific antibodies during the study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Glycemic control - HbA1c level: each visit (0,3,6,9,12,15,18,21 and 24 months)
    • Daily insulin dose: every 6 months (0,6,12,18 and 24 months)
    • Glucose profile: each visit (0,3,6,9,12,15,18,21 and 24 months)
    • C-peptide secretion during GST: every 12 months (0,12 and 24 months)
    • C-peptide secretion during the MMTT: twice (at extra visits at 12 and 24 months)
    • Basal, fasting C-peptide secretion: every 6 months (0,6,12,18 and 24 months)
    Safety relevant measurements at each visit, like hematology and chemistry, dermal hypersensitivity test, or every 6 months like fasting chemistry and plasma glucose. ECG (12 and 24 months) and others as indicated in the protocol. DiaPep277 specific antibodies at 0, 12 and 24 months
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belarus
    Czech Republic
    Germany
    Hungary
    Israel
    Italy
    Lithuania
    Poland
    Russian Federation
    Serbia
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 281
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 119
    F.4.2.2In the whole clinical trial 281
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At this stage there are no formal plans for treatment or care after the subject has completed the study. The Sponsor may decide to extend treatment and follow-up of efficacy and safety beyond the original protocol of 24 months.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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