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    The EU Clinical Trials Register currently displays   43855   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-002590-73
    Sponsor's Protocol Code Number:901
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-08
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-002590-73
    A.3Full title of the trial
    A PHASE III, MULTINATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE CLINICAL EFFICACY AND SAFETY OF DIAPEP277™ IN NEWLY DIAGNOSED TYPE 1 DIABETES PATIENTS
    A.3.2Name or abbreviated title of the trial where available
    DIA-AID
    A.4.1Sponsor's protocol code number901
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDIAPEP277™
    D.3.9.1CAS number 179822-83-4
    D.3.9.2Current sponsor codePO-102 Peptide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for suspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type I Diabetes
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10045228
    E.1.2Term Type I diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigate the effect of DiaPep277™ versus placebo in patients with Type 1 Diabetes Mellitus (T1D) on pancreatic beta-cell function as measured by glucagon stimulated C-peptide secretion.
    E.2.2Secondary objectives of the trial
    Key Secondary:
    • Assess the effect of DiaPep277® on metabolic control
    • Investigate the effect of DiaPep277® on MMTT-stimulated C-peptide secretion
    • Investigate the effect of DiaPep277® on basal, fasting C-peptide secretion
    Exploratory Secondary:
    • Assess the effect of DiaPep277® on glycemic excursions
    • Other parameters for Beta-cell function
    • Immunological response
    Safety:
    • Assess the safety and tolerability of DiaPep277®
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients meeting all of the following inclusion criteria at screening should be considered for admission to the study:
    1. The patient has a diagnosis of T1D mellitus according to the ADA/WHO for up to 3 months.
    2. Evidence of residual beta-cell function demonstrated by basal fasting C-peptide concentrations ≥ 0.22 nmol/L.
    3. Presence of 1 or more of the following criteria:
    • at least 1 diabetes-related autoantibody: IA-2, insulin or GAD at screening;
    • and/or: age at diagnosis < 20 years and ketonuria at diagnosis.
    4. The patient is on insulin treatment for diabetes since diagnosis.
    5. The patient is male or female, aged 16 to 45 years, inclusive.
    6. If a female of child-bearing potential, the patient is not pregnant or lactating, and will use oral hormonal contraception or other equally effective contraceptive methods throughout the study.
    7. Stable medical condition for diseases, other than diabetes, during 30 days before screening visit.
    8. Body mass index (BMI) equal to or greater than 17 kg/m2 and not greater than 28 kg/m2 at screening visit
    9. Signed informed consent to participate in the study
    10. Ability to comply with all study requirements.
    11. The patient is on intensive insulin therapy (basis/bolus insulin) or is willing to initiate intensive insulin therapy or is using an insulin pump.
    Patients meeting the following inclusion criteria at baseline visit (visit 1) are considered eligible for randomization:
    1. The patient has a diagnosis of T1D mellitus according to the ADA/WHO for up to 4 months.
    2. The patient has NOT
    • had mean blood glucose levels > 200 mg/dl during any 3 days within the week before baseline visit
    • ketoacidosis
    • Ketonuria on urine stix testing (+)
    E.4Principal exclusion criteria
    Patients meeting any of the following exclusion criteria at screening will not be enrolled in the study.
    1. The patient is treated with inhaled insulin.
    2. The patient has had unintentional/unplanned weight loss of ≥ 10 percent of body weight within the previous 6 months.
    3. The patient has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the Investigator, are likely to affect the patient's response to treatment or the ability to complete the study.
    4. The patient has a history of any kind of malignant tumor (not including basal cell skin cancer).
    5. The patient has clinical evidence of any diabetes-related complication that in the opinion of the Investigator would interfere with the patient's participation in and/or completion of the study.
    6. Patient has history of endogenous allergic reactivity:
    • Severe allergic reaction or severe exacerbation of allergic asthma within 12 months prior to screening visit.
    • Ongoing systemic asthma treatment.
    • Patients with history of life threatening or severe allergy, re-occurrence of which cannot be ruled out based on the Investigator’s judgment.
    7. The patient has known allergy to lipid emulsions.
    8. The patient has a known immune deficiency from any disease, or a condition associated with an immune deficiency.
    9. The patient is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy, or any medication that, in the opinion of the Investigator, might interfere with the study.
    10. The patient 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 visit.
    • Total bilirubin greater than 1.3 times the ULN at the screening visit.
    • Patients with severe renal failure at the screening visit (as defined by glomerular filtration rate < 30 mL/min/1.73 m2 by Cockroft und Gault calculation [13])
    • Clinically significant laboratory abnormalities, confirmed by repeat measurement, that may interfere with the assessment of safety and/or efficacy of the study drug, other than hyperglycemia and glycosuria at the screening visit.
    • Fasting triglycerides > 1000 mg/dL (11.3 mmol/L) at the screening visit. Suitable medical therapy for treatment of hyperlipidemia is allowed.
    11. The patient is a known or suspected drug abuser.
    12. The patient is known to test positive for HIV antibodies.
    13. The patient has chronic hematologic disease.
    14. The patient has liver disease such as cirrhosis or chronic active hepatitis.
    15. The patient has received any investigational drug within 3 months prior to
    Visit 1.
    16. The patient has already been treated with DiaPep277TM.
    17. The patient 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 8.2.
    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate the efficacy of add-on therapy with DiaPep277® on intensive insulin therapy in subjects with newly diagnosed T1D, by testing the hypothesis that pancreatic beta-cell function with DiaPep277® is superior to that with placebo after 24 months (9 administrations, 21 months treatment, 3 months follow up). Primary efficacy endpoint will be the difference in beta-cell function between Placebo and DiaPep277® treated, as determined by change from baseline in glucagon-stimulated C-peptide AUC secretion
    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 Information not present in EudraCT
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.2Adults (18-64 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-08. Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 500
    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 Decision2005-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-31
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