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    Summary
    EudraCT Number:2022-002356-39
    Sponsor's Protocol Code Number:D/P2/22/8
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-13
    Trial 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 number2022-002356-39
    A.3Full title of the trial
    DiaPrecise, A Phase II Open Label Study to evaluate the safety and
    feasibility of intralymphatic administration of Diamyd® in
    individuals at risk for Type 1 diabetes carrying the HLA DR3-DQ2
    haplotype
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the safety and feasibility of the intralymphatic administration of the investigational drug Diamyd in children at risk to develop type-1 diabetes
    A.3.2Name or abbreviated title of the trial where available
    DiaPrecise
    A.4.1Sponsor's protocol code numberD/P2/22/8
    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 SponsorDiamyd Medical AB
    B.1.3.4CountrySweden
    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 supportDiamyd Medical AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiamyd Medical AB
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressKungsgatan 29, Box 7349
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post codeSE-103 90
    B.5.3.4CountrySweden
    B.5.4Telephone number+468661 00 26
    B.5.6E-mailclinicaltrials@diamyd.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 nameDiamyd
    D.3.2Product code rhGAD65 formulated in alum (GADalum)
    D.3.4Pharmaceutical form Suspension 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 INNRecombinant human GAD65
    D.3.9.1CAS number 9024-58-2
    D.3.9.2Current sponsor coderhGAD65
    D.3.9.3Other descriptive nameGlutamate decarboxylase 2, human, recombinant
    D.3.9.4EV Substance CodeSUB222827
    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
    Stage 1 or stage 2 pre-type1 diabetes (seropositive for two or more T1D–associated autoantibodies)
    E.1.1.1Medical condition in easily understood language
    Prediabetes (the autoimmune process leading to type 1 diabetes)
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 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
    The primary objective is to evaluate the feasibility and safety of two and three intralymphatic injections
    of Diamyd (one month apart) in individuals aged 8 - <18 years with Human Leukocyte Antigen (HLA)
    haplotype DR3-DQ2 and multiple islet autoantibodies (Stage 1 or Stage 2) at increased risk for Type 1
    Diabetes (T1D).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the effect of Diamyd treatment on the individuals’ immune
    system and metabolic status as well as progression from Stage 1 to Stage 2 or Stage 3 T1D.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent/assent from the individual and the individual’s parents or caretaker(s)
    according to local regulations.
    2. Males and females aged ≥8 and <18 years old at the time of Screening.
    3. Possess the HLA DR3-DQ2 haplotype.
    4. Seropositive for GADA and at least one additional T1D-associated autoantibody (IA-2A,
    ZnT8A or IAA).
    E.4Principal exclusion criteria
    1. Diagnosis of T1D (stage 3 T1D, according to the American Diabetes Association
    [ADA] classification).
    2. Fasting glucose > 7 mmol/L (126 mg/dl), 2-hour-OGTT plasma glucose > 11.1 mmol/L (200
    mg/dL) or HbA1c > 6.5% (48 mmol/mol) at the screening Visit.
    3. Treatment with any anti-diabetic medication, including the use of external insulin.
    4. Participation in any other clinical trial testing pharmaceutical treatments.
    5. Recent (past 12 months) or current treatment with immunosuppressant therapy, including
    chronic use of glucocorticoid therapy. Inhaled, topical, and intranasal steroid use is acceptable.
    Short courses (e.g., ≤5 days) of oral or intra-articular injections of steroids will be permitted on
    trial.
    6. History of hyperparathyroidism, hypercalcemia and/or nephrolithiasis, unless appropriately
    treated, or any other contraindication to use of Vitamin D.
    7. History of epilepsy, serious head trauma or cerebrovascular accident, or clinical features of
    continuous motor unit activity in proximal muscles
    8. Any clinically significant history of an acute reaction to a vaccine or its constituents (e.g.,
    Alhydrogel) or lidocaine (local anesthetic)
    9. Any acute or chronic skin infection or condition that would preclude intralymphatic injection.
    10. Treatment with any (live or inactive) vaccine, including influenza vaccine and Coronavirus
    Disease 2019 (COVID-19) vaccine, within 4 weeks prior to planned first dose of study drug; or
    planned treatment with any vaccine up to 4 weeks after the last injection with study drug.
    11. Ongoing diagnosed post-COVID19 syndrome.
    12. Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
    Individuals with previous hepatitis C infection that is now cured may be eligible.
    13. Any clinically significant concomitant medical condition, including but not limited to other
    autoimmune diseases, cardiovascular, gastrointestinal, hematological, immune, renal including a
    history of renal transplantation or neurological that in the opinion of the investigator would
    interfere with trial participation or procedures. Celiac disease with adequate diet as well as
    stable autoimmune thyroiditis will be permitted.
    14. Any clinically significant abnormal findings detected during Screening that might jeopardize the
    individual’s safety or ability to complete the trial.
    15. Females who are lactating or pregnant (for females who have started menstruating the
    possibility of pregnancy must be excluded by urine βHCG onsite prior to the study drug
    administration).
    16. Males or females not willing to use adequate contraception, if sexually active, until 90 days
    after the last Diamyd administration. Adequate contraception is as follows:
    For females of childbearing potential (FOCBP)
    a. oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted
    hormonal contraceptives
    b. intrauterine device
    c. intrauterine system (for example, progestin-releasing coil)
    d. refraining from heterosexual intercourse if that is the preferred and usual lifestyle of the
    subject.
    For sexually active males
    a. condom
    b. Abstinence from heterosexual intercourse if that is the preferred and usual lifestyle of the
    subject.
    c. Vasectomy
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint
    • Variables that indicate safety and feasibility of treatment:
    - Occurrence of AEs (including Injection site reactions) and SAEs
    - Physical examinations, including neurological assessments
    - Laboratory measurements, including hematology, clinical chemistry, metabolic status
    parameters (fasting C-peptide, HbA1c, fasting glucose) and urine analysis
    E.5.1.1Timepoint(s) of evaluation of this end point
    month 6, month 12
    E.5.2Secondary end point(s)
    Secondary endpoints
    • Number of individuals progressing from stage 1 to stage 2 and from stage 2 to stage 3.
    • Time to T1D diagnosis.
    • Time from stage 1 to stage 2. and time from stage 2 to stage 3.
    • Change in C-peptide /insulin /glucose (Area Under the Curve [AUC]mean 0-120 min) during a 2-hour
    Oral Glucose Tolerance Test (OGTT) from screening to 6, 12 months.
    • Change in Hemoglobin A1c (HbA1c) from baseline to 6, 12 months.
    • Change in time in glycemic target range 3.9 to 10 mmol/L (70 to 180 mg/dL) and 3.9 to 7.8
    mmol/L (70 to 140 mg/dL) evaluated from continuous glucose monitoring (CGM) data from
    screening to 6, 12 months.
    • Change in time in range > 13.9 mmol/L (> 250 mg/dL) evaluated from CGM data from
    screening to 6, 12 months.
    • Change in time in range > 10 mmol/L (> 180 mg/dL) evaluated from CGM data from screening
    to 6, 12 months.
    • Change in time in range > 7.8 mmol/L (> 140 mg/dL) evaluated from CGM data from screening
    to 6, 12 months.
    • Change in glycemic variation (Coefficient of variation [CV], SD) evaluated from CGM data
    from screening to 6, 12 months.
    • Variables that indicate effects on the immune system such as the concentration of serum
    autoantibodies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    month 6, month 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 No
    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 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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 16
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 6
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) No
    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 No
    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 state16
    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)
    None
    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 Decision2022-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
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