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    Summary
    EudraCT Number:2019-002692-34
    Sponsor's Protocol Code Number:GADinLADA
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-11-18
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-002692-34
    A.3Full title of the trial
    A pilot study on safety, feasibility and insulin-promotion by intra-inguinal lymph node injections of glutamic acid decarboxylase (GAD) in patients with LADA type of diabetes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot study to test if a vaccine against autoimmune destruction of the pancreatic insulin-producing cells, when injected directly into a lymph node, is safe and feasible for persons with the LADA (Latent Autoimmune Diabetes in Adults) type of diabetes.
    A.4.1Sponsor's protocol code numberGADinLADA
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04262479
    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 SponsorNTNU, Dept of Clinical and Molecular Medicine, Gastrosenteret
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCentral Norway Regional Health Authority
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNTNU, Dep of Clinical and Molecular Medicine, Gastrosenteret
    B.5.2Functional name of contact pointIngrid K Hals
    B.5.3 Address:
    B.5.3.1Street AddressPrinsesse Kristinagt 1
    B.5.3.2Town/ cityTrondheim
    B.5.3.3Post code7030
    B.5.3.4CountryNorway
    B.5.6E-mailingrid.hals@ntnu.no
    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 namerhGAD65-alum
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGAD-alum
    D.3.9.3Other descriptive nameRHGAD65
    D.3.9.4EV Substance CodeSUB32062
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    Latent autoimmune diabetes in adults (LADA): A common type of diabetes defined by age >30 years, positivity for anti-GAD and no need for insulin the first 6 months after the onset of diabetes.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10066389
    E.1.2Term Latent autoimmune diabetes in adults
    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
    The purpose of the trial is to evaluate the effects of 3 intra-nodal injections of GAD-alum in a population of LADA patients with high GADA titers. The primary objective is to evaluate safety and feasibility of this treatment regimen.

    The pilot study will be performed in order to support the launch of a larger placebo controlled clinical trial in the LADA population.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to test if the treatment induces a strong GAD-specific immune response similar to what has previously been observed in type 1 diabetes patients and to test for indications of preservation of endogenous insulin production.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent by the patient.
    2. Diagnosis of LADA and diabetes debut within the last 18 months before inclusion
    3. Male or female between 30-70 years of age
    4. Fasting C-peptide levels ≥ 0.3 nmol/l
    5. High anti-GAD titers (>190 U/ml)
    6. Patients must be insulin independent at baseline by clinical judgement and C-peptide criteria
    7. Antidiabetic medication in the form of metformin is acceptable for inclusion as well as medications not mentioned under exclusion criteria
    8. Females must agree to avoid pregnancy and have a negative urine pregnancy test.
    Patients of childbearing potential must agree to use adequate contraception, until one (1) year after the last administration of GAD-alum
    E.4Principal exclusion criteria
    1. Current or previous treatment with immunosuppressant therapy (topical or inhaled steroids are accepted)
    2. Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
    3. Systemic treatment with glucocorticoids
    4. Treatment with any vaccine, including influenza vaccine, within 1 month prior to planned first study drug dose or planned treatment with any vaccine up to 1 month after the last injection with study drug
    5. Antidiabetic medication (metformin excepted)
    6. Significantly abnormal hematology results at screening
    7. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
    8. Clinically significant history of acute reaction to vaccines in the past.
    9. Renal disease (as defined by serum creatinine >150 µmol/l)
    10. Serious cardiovascular events (myocardial infarction, stroke) within the last year preceding recruitment.
    11. Participation in other clinical trials with a new chemical entity within the previous 3 months
    12. A history of alcohol or drug abuse
    13. Known HIV or hepatitis
    14. Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic injection, which in the opinion of the investigator makes the patient non-eligible for the study
    15. Other serious chronic disease as judged by investigator.
    16. Females who are lactating, are pregnant or intend to become pregnant.
    17. Inability or unwillingness to comply with the provisions of this protocol
    18. Deemed by the investigator not being able to follow instructions and/or follow the study protocol
    19. Treatment with any other supplementation of vitamin D, marketed or not, or unwilling to abstain from such medication during the 120 days daily intake of Divisun (non-investigational medicinal product)
    E.5 End points
    E.5.1Primary end point(s)
    Variables for evaluation of safety and feasibility:
    1) Injection site reactions
    2) Occurrence of AEs
    3) Laboratory measurements (hematology and clinical chemistry)
    4) Physical examinations, including neurological assessments
    5) anti-GAD65 titer in serum
    6) Vital signs (blood pressure)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Injection site reactions will be evaluated 1 hour post injection vs. before injection.

    2) Occurrence of Adverse Events will be evaluated continuously during the study. Status will be summarized at 5 and 12 months after the first injection.

    3)-6) Status will be summarized at 5 and 12 months after the first injection.
    E.5.2Secondary end point(s)
    Variables for the evaluation of beta cell insulin secretion capacity and metabolic control:
    1) Insulin secretion capacity measured by glucagon- and MMTT (mixed meal tolerance test) stimulated C-peptide.
    2) HbA1c.
    3) Fasting glucose.
    4) Fasting C-peptide
    5) Maximum C-peptide during MMTT.

    Variables for the evaluation of immunological response:
    6) Serum concentration of GAD65-specific IgG1, IgG2, IgG3 and IgG4 antibodies for all included patients
    7) Supernatant concentrations of IL-1, IL-2, IL-5, IL-13, IL-10, IL-17, IFN-γ and TNF secreted during cultivation of PBMCs isolated from all included patients
    8) Characterization of PBMCs with FACS using CD3, CD4, CD8, CD45RA, CCR7, CD25, CD127, FOXp3 at baseline
    9) Analyses of the proliferation of PBMCs isolated from all included patients during cultivation with vehicle, GAD65 and control antibody.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)-9) Status will be summarized at 5 and 12 months after the first injection of GAD-alum and compared to status at baseline.
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 end of the trial is defined as the last visit of the last patient included in the trial and all data have been collected.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 15
    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)
    After the individual completion of the study, the patient will return to the standard treatment received prior to the study participation.
    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 Decision2020-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-05-05
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