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    Summary
    EudraCT Number:2016-000715-33
    Sponsor's Protocol Code Number:2015DM07
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-01
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-000715-33
    A.3Full title of the trial
    Does Dapaglifozin Regress Left Ventricular Hypertrophy In Patients With Type 2 Diabetes?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does Dapaglifozin Regress Left Ventricular Hypertrophy In Patients With Type 2 Diabetes?
    A.3.2Name or abbreviated title of the trial where available
    DAPA-LVH Trial
    A.4.1Sponsor's protocol code number2015DM07
    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 SponsorUniversity of Dundee & NHS Tayside
    B.1.3.4Country
    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
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Dundee
    B.5.2Functional name of contact pointStruthers
    B.5.3 Address:
    B.5.3.1Street AddressDivision of Molecular and Clinical Medicine
    B.5.3.2Town/ cityNinewells Hospital
    B.5.3.3Post codeDD1 9SY
    B.5.4Telephone number01382 383199
    B.5.6E-maila.d.struthers@dundee.ac.uk
    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 Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Myers Squibb/Astra Zeneca EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameForxiga
    D.3.4Pharmaceutical form 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 INNdapagliflozin
    D.3.9.1CAS number 461432-26-8
    D.3.9.3Other descriptive nameDapagliflozin propanediol monohydrate
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboTablet
    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 2 diabetes and left ventricular hypertrophy
    E.1.1.1Medical condition in easily understood language
    Diabetes and thickening of the heart muscle
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061024
    E.1.2Term Cardiac disorder
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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 see if Dapagliflozin reduces left ventricular size more than placebo in participants with type 2 diabetes and left ventricular hypertrophy
    E.2.2Secondary objectives of the trial
    To confirm expected effect of dapagliflozin on blood pressure (reduce blood pressure)
    To assess the effect of dapagliflozin on left ventricular diastolic function and global longitudinal strain
    To confirm expected effect of dapagliflozin on body weight (reduce weight)
    To assess the effect of dapagliflozin on visceral fat mass.
    To assess the effects of dapagliflozin on blood biomarkers.
    To assess the tolerability of dapagliflozin in this patient group
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent before any trial specific procedures.
    2. Diagnosed with type 2 diabetes mellitus based on the current American Diabetes Association guidelines.
    3. Aged >18 and <80 years
    4. Body Mass Index ≥23
    5. HbA1c 48-85mmol/mol (last known result within in the previous 6 months)
    6. BP <145/90mmHg
    7. Echocardiographic LV hypertrophy (defined as either an LV mass index of >115g/m2 for men and >95g/m2 for women indexed to body surface area or > 44g/m2.7 or 48g/m2.7 when indexed to height) within the previous 6 months.
    8. Women of childbearing potential must agree to take precautions to avoid pregnancy throughout the trial and for 4 weeks after intake of the last dose.
    E.4Principal exclusion criteria
    1. Any condition that in the opinion of the investigator may render the participant unable to complete the trial including non CV disease (e.g. active malignancy).
    2. Participants with type 1 diabetes mellitus
    3. Diagnosis of clinical heart failure
    4. History of humun immunodeficiency virus
    5. LV systolic dysfunction (LVEF <45%) (last known result within in the previous 6 months)
    6. eGFR <45ml/min (last known result within in the previous month)
    7. Known liver function tests >3 times upper limit of normal (based on last measures and documented laboratory measurement in the previous 6 months)
    8. Body weight >150Kg (unable to fit into a MRI scanner)
    9. Contraindications to MRI (e.g. claustrophobia, metal implants, penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
    10. Past or current treatment with any SGLT2 inhibitor
    11. Allergy to any SGLT2 inhibitor or lactose or galactose intolerance
    12. Current treatment with loop diuretic
    13. Currently receiving long term (>30 consecutive days) treatment with an oral steroid
    14. Pregnant or breast feeding participants
    15. Involvement in the planning and/or conduct of the trial (applies to Astra Zeneca or representative staff and/or staff at the trial site).
    16. Participation in another interventional study (other than observational trials and registries) within 30 days before visit 1.
    17. Individuals considered at risk for poor protocol or medication compliance.
    E.5 End points
    E.5.1Primary end point(s)
    LV Mass by Cardiac MRI
    E.5.1.1Timepoint(s) of evaluation of this end point
    0 & 52 weeks
    E.5.2Secondary end point(s)
    1) To confirm expected effect of dapagliflozin on 24 hour BP
    2) To confirm expected effect of dapagliflozin on Office BP
    3) To confirm expected effect of dapagliflozin on body weight
    4) To assess the effect of dapagliflozin on visceral fat mass.
    5) To assess the effects of dapagliflozin on biomarkers.
    6) To assess the tolerability of dapagliflozin in this patient group
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 0 & 52 weeks
    2) 0, 4, 17, 34 & 52 weeks
    3) 0, 4, 17, 34 & 52 weeks
    4) 0 & 52 weeks
    5) 0, 4, 17, 34 & 52 weeks
    6) 0, 4, 17, 34 & 52 weeks
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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 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 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
    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 months3
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 64
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-15
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