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    Summary
    EudraCT Number:2009-015929-37
    Sponsor's Protocol Code Number:1001
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-08
    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 ConcernedAustria - BASG
    A.2EudraCT number2009-015929-37
    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 SUBJECTS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study in patients who just developed type 1 diabetes, to look at the benefit and safety of DiaPep277 compared to placebo (control).
    A.3.2Name or abbreviated title of the trial where available
    DIA-AID 2
    A.4.1Sponsor's protocol code number1001
    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+34928351053
    B.5.5Fax number+34914314495
    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 Powder and solvent for solution 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 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
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for solution 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
    E.1.1.1Medical condition in easily understood language
    Type 1 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
    Assess the effect of DiaPep277® versus placebo in subjects with Type 1 Diabetes Mellitus (T1D) on endogenous insulin secretion or pancreatic beta cell function as measured by AUC0-20mins calculated from C-peptide concentration vs. time curve of glucagon-stimulated test (GST).
    E.2.2Secondary objectives of the trial
    1. Major Clinical Endpoints:
    -Assess effect of DiaPep on % of subjects that achieve HbA1c≤7%
    -Assess effect of DiaPep on % of subjects who require a daily insulin dose ≤ 0.5 IU/kg body weight
    -Assess effect of DiaPep on hypoglycemic events and event rate
    2. Additional Clinical Endpoints:
    -Assess effect of DiaPep on glycemic control (%HbA1c) at study end
    -Assess effect of DiaPep on daily insulin dose per body weight at study end
    -Assess effect of DiaPep on glycemic control according to MAGE calculated from 7 point glucose profile and CGMS data
    3. Beta-cell function Endpoints - Assess effect of DiaPep on other measurements of endogenous insulin secretion:
    -AUC0-120 calculated from concentration vs. time curve of mixed-meal tolerance test (MMTT) C-peptide secretion
    -GST and MMTT peak C-peptide concentration Cmax
    -Percent of subjects with Cmax >= 0.2 nmol/L at end of study for GST and MMTT
    -Fasting C-peptide
    4. Assess the safety and tolerability of DiaPep

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject can be randomized within no more than 6 months following the diagnosis of T1D mellitus according to the ADA/WHO criteria (2010 update of ADA recommendations). To achieve this, subject should be screened up to 5 months after diagnosis. Any period of misdiagnosis with T2D or unspecified type should be included in the calculation, although the initial misdiagnosis itself is not basis for exclusion.
    2. Evidence of residual beta-cell function demonstrated by basal fasting C-peptide concentrations ≥ 0.22 nmol/L, but not more than 0.8 nmol/L.
    3. The subject is positive for at least 1 diabetes-related autoantibody: IA-2A, IAA or GADA at screening. Subjects with only IAA must be no more than 1 month on insulin therapy.
    4. The subject has been on insulin treatment for diabetes within 1 month since diagnosis of T1D mellitus.
    5. The subject is male or female, aged 20 to 45 years, inclusive.
    6. If a female of child-bearing potential, the subject 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 the Screening Visit.
    8. Body mass index (BMI) equal to or greater than 17 kg/m2 and not greater than 30 kg/m2 at the Screening Visit.
    9. Signed informed consent to participate in the study
    10. Ability to comply with all study requirements.
    11. The subject is willing to initiate intensive insulin therapy (basis and bolus insulin) at study entry, or is using an insulin pump
    E.4Principal exclusion criteria
    1 The subject has a diagnosis of latent autoimmune diabetes in adults (LADA) (Pozzilli and Di Mario 2001).
    2 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.
    3 The subject has a prior history of any kind of malignant tumor excluding adequately treated basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix.
    4 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.
    5 Subject has history of endogenous allergic reactivity:
    a. Severe allergic reaction or severe exacerbation of allergic asthma within 12 months prior to the Screening 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.
    d. The subject has known allergy to lipid emulsions.
    6 The subject has a known immune deficiency from any disease, or a condition associated with an immune deficiency.
    7 The subject is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy or any medication for more than 4 weeks that in the opinion of the Investigator might interfere with the study.
    8 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 Visit.
    b. Total bilirubin greater than 2 times the ULN at the Screening Visit.
    c. Subjects with severe renal failure at the screening visit (as defined by glomerular filtration rate < 30 mL/min/1.73 m2 by Cockroft Gault calculation (Cockcroft and Gault 1976)).
    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 Visit.
    e. Fasting triglycerides >1000 mg/dL (11.3 mmol/L) at the Screening Visit. Suitable medical therapy for treatment of hyperlipidemia is allowed.
    9 The subject is a known or suspected drug abuser.
    10 The subject is known to test positive for HIV antibodies.
    11 The subject has chronic hematologic disease.
    12 The subject has liver disease such as cirrhosis or chronic active hepatitis.
    13 The subject has received any investigational drug or participated in another clinical study for the indication of prevention or treatment of diabetes, at any point in the past.
    14 The subject has received any investigational drug, not diabetes-related, within 1 month prior to the Baseline Visit (Visit 1).
    15 The subject has already been treated with DiaPep277®.
    16 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.
    17 The subject receives a forbidden medication (listed within section 7.2. of study protocol)
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to demonstrate the efficacy of DiaPep277® in subjects with newly diagnosed T1D on intensive insulin therapy, by testing the hypothesis that pancreatic beta-cell function with DiaPep277® is superior to that with placebo after 10 administrations, 24 months of treatment. The primary efficacy endpoint will be the beta-cell function, as determined by the change from baseline up to the 24-month endpoint AUC0-20min calculated from concentration-time curve of GST C-peptide secretion throughout the course of the study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is evaluated at Baseline, 12, and 24 months
    E.5.2Secondary end point(s)
    To demonstrate the effect of DiaPep277® on major clinical endpoints:
    - The percentage of subjects in the DiaPep277® group achieving the glycemic target of HbA1c ≤ 7% compared to the placebo group.
    - The percentage of subjects with low daily insulin requirement in the DiaPep277® group compared to the placebo group at end of study, as determined by the number of subjects with daily insulin dose ≤ 0.5 IU/kg body weight.
    - To test the hypothesis that the number or the rate of hypoglycemic events (FPG < 3.9 mmol/L) per subject month, as documented in subject diaries, is decreased with DiaPep277® treatment compared to placebo, over the whole study total follow-up period.
    - To demonstrate the effect of DiaPep277® on additional clinical endpoints:
    o To test the hypothesis that improved glycemic control, as defined by a lower % HbA1c, is improved with DiaPep277® treatment compared to placebo at the end of study.
    o The mean amplitude of glucose excursion (MAGE) in subjects in the DiaPep277® group compared to the placebo group.
    o To test the hypothesis that disease management, as defined by lower daily insulin [IU] per body weight [kg] requirement, is improved with DiaPep277® treatment compared to placebo at the end of study.
    o The percentage of subjects in the DiaPep277® group achieving the glycemic target of HbA1c ≤ 7%, together with low daily insulin dose ≤ 0.5 IU/kg body weight, compared to the placebo group, at the end of study.
    o Lowering the mean amplitude of post-prandial glucose excursions in subjects in the DiaPep277® group compared to the placebo group, as recorded by CGMS.
    o 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.
    - To demonstrate the effect of DiaPep277® on the following aspects of beta-cell function:
    For the GST-derived parameters, the end of study data will be taken from Visit 10, Month 24. For the MMTT-derived parameters, the end of study data will be taken from Visit 11, Month 25.
    o The difference between the placebo and DiaPep277® groups, as determined by the change from baseline (Pre-Visit 1 or Qualification Visit for MMTT) up to the end of study in MMTT-stimulated C-peptide (AUC0-120 min).
    o The difference between placebo and DiaPep277® groups, from baseline (Visit 1) up to the end of study, in the GST-stimulated Cmax.
    o The difference between placebo and DiaPep277® groups, from baseline (Pre-Visit 1 or Qualification Visit) up to the end of study, in the MMTT-stimulated Cmax.
    o The difference between placebo and DiaPep277® groups, from baseline (Visit 1) up to the end of study in fasting C-peptide.
    o The percentage of subjects with maintained beta-cell function in the DiaPep277® group compared to the placebo group at the end of study, as determined by the number of subjects with peak C-peptide levels >= 0.2 nmol/L, as measured after GST and/or MMTT.
    o Time to event Cmax<0.2 nmol/L, as measured after GST and/or MMTT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    MMTT-stimulated secretion is measured at Baseline (before first administration), 18 and 25 months. The other Secondary Endpoints are evaluated at each visit (every 3 months).
    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 Yes
    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.8.2.4Number of treatment arms in the trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Argentina
    Austria
    Belarus
    Canada
    Czech Republic
    Germany
    Hungary
    Israel
    Italy
    Lithuania
    Poland
    Romania
    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
    The last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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: 474
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 474
    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 25 months. In selected countries patients have the possibility to enter into the extension study 1010.
    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 Decision2010-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-28
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