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    Summary
    EudraCT Number:2020-000435-45
    Sponsor's Protocol Code Number:Ver-A-T1D
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-08
    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 ConcernedAustria - BASG
    A.2EudraCT number2020-000435-45
    A.3Full title of the trial
    A randomised, double-blind, placebo controlled, parallel group, multi-centre trial in adult subjects with newly diagnosed type 1 diabetes mellitus investigating the effect of Verapamil SR on preservation of beta-cell function (Ver-A-T1D)
    Eine randomisierte , doppelblinde , placebokontrollierte , Parallelgruppen- und multizentrische Studie an erwachsenen Patienten mit neu diagnostiziertem Typ-1-Diabetes Mellitus zur Untersuchung der Wirkung von Verapamil SR auf die Erhaltung der Beta-Zell-Funktion (Ver-A-T1D)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial in adults with newly diagnosed type 1 diabetes mellitus investigating the effect of Verapamil SR on the preservation of beta-cell function
    A.4.1Sponsor's protocol code numberVer-A-T1D
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04545151
    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 SponsorMedical University of Graz
    B.1.3.4CountryAustria
    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 support"Innovative Medicines Initiative 2" (Call: IMI2- Call1: Grant Agreement Number: 115797)
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz, Clinical Trials Unit
    B.5.2Functional name of contact pointMartina Brunner
    B.5.3 Address:
    B.5.3.1Street AddressStiftingtalstrasse 24
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8010
    B.5.3.4CountryAustria
    B.5.4Telephone number+43316385 72841
    B.5.6E-mailmartina.brunner@medunigraz.at
    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 Yes
    D.2.1.1.1Trade name VeraHEXAL KHK 120 mg retard Retardtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVERAPAMIL HYDROCHLORIDE PH. EUR.
    D.3.9.1CAS number 52-53-9
    D.3.9.4EV Substance CodeSUB172220
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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 placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 diabetes mellitus(T1DM)
    E.1.1.1Medical condition in easily understood language
    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
    To determine the changes in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) at baseline and after 12 months for 360mg Verapamil SR administered orally once daily versus placebo.
    E.2.2Secondary objectives of the trial
    To determine the effects of 360mg Verapamil SR administered orally once daily on fasting C-peptide and
    Dried Blood Spot (DBS) C-peptide measurements over time.
    To determine the effects of 360mg Verapamil SR administered orally once daily on HbA1c daily total insulin dose and continous glucose monitoring (CGM) time in range.
    To determine the effects of treatment on other biomarkers related to immunological changes and
    beta-cell death and survival in this population.
    To determine the effects of 360mg Verapamil SR administered orally once daily on safety (vital signs,
    ECG).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Have given written informed consent
    • Age ≥18 and <45 years at consent
    • Must have a diagnosis of T1D of within 6 weeks duration at screening (from date of the first insulin injection)
    • Must have at least one or more diabetes-related autoantibodies present at screening
    • Must have random C-peptide levels ≥200 pmol/L measured at screening
    • Be willing to comply with intensive diabetes management
    E.4Principal exclusion criteria
    • Exclusion Criteria:
    1. Be immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (< 3,000 leukocytes /µL), neutropenia (<1,500 neutrophils/µL), lymphopenia (<800 lymphocytes/µL), or thrombocytopenia (<100,000 platelets/µL)
    2. Have active signs or symptoms of acute infection at the time of screening
    3. Be currently pregnant or lactating, or anticipate getting pregnant during the 12 months study period
    4. Require use of immunosuppressive agents including chronic use of systemic steroids
    5. Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
    6. Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, chronic obstructive pulmonary disease (COPD), sickle cell disease, neurological, or blood count abnormalities, as judged by the investigator
    7. Have persistent history of malignancies other than skin
    8. History of liver insufficiency or laboratory evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal
    9. History of renal insufficiency or evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal
    10. Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control within prior 7 days of screening
    11. Use of any other investigational drug in the previous 30 days and/or intent on using any investigational drug for the duration of the trial
    12. Current use of Verapamil or other calcium channel blockers
    13. Known hypersensitivity to Verapamil or to any of its excipients
    14. Concomitant medication known for significantly inducing or inhibiting CYP3A4 and/or glycoprotein-P metabolism
    15. Intake of grapefruit juice, licorice, St.John’s Wort, cannabidiol, ginkgo biloba
    16. Substrate intake of CYP3A4 and/or glycoprotein-P metabolism, as judged by the investigator
    17. Hypotension (of less than 100mmHg systolic), sick sinus syndrome (except patients with a functioning artificial pacemaker), uncompensated heart failure or severe left ventricular dysfunction; marked bradycardia (less than 50 beats/minute), atrial flutter or atrial fibrillation in the presence of an accessory bypass tract (e.g. Wolff-Parkinson-White syndrome), hypertrophic cardiomyopathy, acute myocardial infarction, attenuated neuromuscular transmission (e.g. by myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy)
    18. ECG second or third degree atrioventricular block; Incomplete branch block.
    19. Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results.
    20. Current use of ß-blockers.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Measure:
    1. Area under the stimulated C-peptide response curve
    The primary objective is to determine the changes in stimulated C-peptide response during the first two hours of a
    mixed meal tolerance test (MMTT) at baseline and after 12 months for 360mg Verapamil SR administered orally once
    daily versus placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    [Time Frame: At baseline and after 12 Months of therapy]
    E.5.2Secondary end point(s)
    • The area under the stimulated C-peptide response curve over the first two hours of a mixed meal tolerance test (MMTT) at 3, 6, 9 months
    • Proinsulin and, Insulin, Pro-IAPP and Proglucagon preproinsulin secretion during the first two hours of a mixed meal tolerance test (MMTT) at baseline and 3, 6, 9 an 12 months
    • Fasting C-peptide after 12 months therapy compared to placebo
    • The DBS C-peptide measurements at all observation times
    • Change in HbA1c baseline to 12 months
    • Number of treatment emergent severe hypoglycaemic episodes. Severe hypoglycaemia denotes severe cognitive impairment requiring external assistance for recovery according to the American Diabetes Association (ADA)
    • Number of treatment emergent episodes of diabetic ketoacidosis (DKA)
    • Change in insulin requirements, baseline to 12 months as the daily total dose (three days average) in units per kg body weight (BW)
    • Change in T1D associated autoantibodies (GADA, IAA, IA-2A and ZnT8A) from baseline to 12 months
    • Continous glucose monitoring (CGM) time in range (70-140 mg/dL, 3.9-7.8 mmol/L) and (70-180 mg/dL, 3.9-10.0 mmol/L), time above range (>180 mg/dL, >10.0 mmol/L), time below range (<70 mg/dL, < 3.9 mmol/L)
    • The area under the stimulated C-peptide response curve over the first two hours of a mixed meal tolerance test (MMTT) at 24 months
    • Change in HbA1c baseline to 24 months
    • Change in insulin requirements, baseline to 24 months as the daily total dose (three days average) in units per kg BW
    E.5.2.1Timepoint(s) of evaluation of this end point
    As described above
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 EEA22
    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
    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: 120
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    No post treatment planned.
    A follow-up visit is planned 12 months after study completion (optional for the subjects)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation INNODIA
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-16
    P. End of Trial
    P.End of Trial StatusOngoing
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