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    Summary
    EudraCT Number:2014-002742-42
    Sponsor's Protocol Code Number:2013DM19
    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:2015-07-09
    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 number2014-002742-42
    A.3Full title of the trial
    Research into the Effect Of SGLT2 inhibition on left ventricular Remodelling in patients with heart failure and diabetes Mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The REFORM Trial
    A.3.2Name or abbreviated title of the trial where available
    The REFORM Trial
    A.4.1Sponsor's protocol code number2013DM19
    A.5.4Other Identifiers
    Name:Sponsor referenceNumber:2013DM19
    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, Tayside Clinical Trials Unit
    B.5.2Functional name of contact pointDr Fiona Hoagrth
    B.5.3 Address:
    B.5.3.1Street AddressTASC, Level 3 Residencies, Ninewells Hospital
    B.5.3.2Town/ cityDundee
    B.5.3.3Post codeDD1 9SY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01382383233
    B.5.6E-mailf.j.hogarth@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 nameDapagliflozin
    D.3.4Pharmaceutical form Capsule, hard
    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 placeboCapsule, hard
    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 Heart Failure
    E.1.1.1Medical condition in easily understood language
    Diabetes and heart failure
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    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 will be to see if Dapagliflozin can change the harmful effect of scarring in the left ventricle in the heart of type 2 diabetic patients who have mild heart failure.

    This will be done by measuring the size of the left side of the heart muscle with an MRI scan before and after one years of treatment with dapagliflozin or placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the effect of Dapagliflozin on the size of and pumping ability of the heart and to see if dapaliflozin improves exercise ability
    and if it improves fluid retention or if there is a reduction in water tablet (diuretic) use.

    Additionally participants Quality of Life measures will be collected before and after treatment to examine if improvements or deterioration in their condition are reflected in how they feel and manage on a day to day basis.

    As this is a novel use of dapagliflizon in diabetes associated with heart failure, it is important also to check it is safe to use it so information on adverse events and changes in blood markers will be collected.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • are aged 18 years or over
    • were previously diagnosed with Type 2 Diabetes
    • are diagnosed with NYHA functional I-II Heart Failure (HF) with prior echocardiographic evidence of LVSD
    • on furosemide 40mg daily or less, or equivalent loop diuretic
    • have stable HF symptoms for at least three months prior to consent
    • on stable therapy for HF for at least three months prior to consent
    • have not been hospitalised for HF for at least three months prior to consent
    E.4Principal exclusion criteria
    • severe hepatic disease
    • renal disease defined as CKD class 3B or worse (i.e. eGFR<60ml/min)
    • systolic BP <95mmHg at screening visit
    • screening HbA1c <6.0%
    • unable to walk to perform cardio pulmonary exercise testing or 6MWT
    • on insulin, meglitinides eg, repaglinide, or 2nd generation sulphonylureas, eg glipizide
    • malignancy (receiving active treatment) or other life threatening diseases
    • pregnant or lactating women
    • any contraindication to MRI (e.g. claustrophobia, metal implants, penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
    • patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days
    • patients who are unable to give informed consent
    • any other reason considered by a study physician to be inappropriate for inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective will be to assess if dapagliflozin can alter LV remodelling in type 2 diabetic patients with mild HF-LVSD (as measured by MRI).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline- 0 weeks
    Endpoint- 12 months
    E.5.2Secondary end point(s)
    1) To determine if there is a change in LVESV, LVEDV, RVEDV, RVESV, RVEF, ventricular dimensions and left atrial volume with Dapagliflozin in DM associated HF compared with placebo.
    2) To determine if there is a change in bioelectrical impedance analysis as a measure of fluid status with Dapagliflozin in DM associated HF compared with placebo
    3) To determine of Dapagliflozin can improve exercise tolerance in DM patients with CHF pre and post six minute walk test and CPET compared to placebo.
    4) To determine if there are patient reported improvements in quality of life with Dapagliflozin compared to placebo as measured by the Minnesota Living with Heart Failure Questionnaire and SF-36 questionnaire
    5) To determine the effect of Dapagliflozin on BNP and inflammatory or other blood markers in DM associated CHF.
    6) To assess the safety of Dapagliflozin in DM associated HF.
    7) To assess if there are increased or decreased use of diuretics in DM associated HF with Dapagliflozin compared to placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline- 0 weeks
    Endpoint- 12 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 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 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 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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 43
    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 state58
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 58
    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 Decision2014-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-11
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