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    Summary
    EudraCT Number:2016-003719-37
    Sponsor's Protocol Code Number:GN15CA580
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-05-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-003719-37
    A.3Full title of the trial
    StUdies of empaGliflozin and its cArdiovascular, Renal and metabolic effects in patients with Diabetes Mellitus (or prediabetes) and Heart Failure (SUGAR-DM-HF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Studying effects of medication (empagliflozin) in diabetes (or at risk of diabetes) and heart failure
    A.3.2Name or abbreviated title of the trial where available
    SUGAR-DM-HF
    A.4.1Sponsor's protocol code numberGN15CA580
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNHS Greater Glasgow and Clyde
    B.1.3.4CountryUnited Kingdom
    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 supportBoehringer Ingelheim Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Glasgow
    B.5.2Functional name of contact pointProfessor Naveed Sattar
    B.5.3 Address:
    B.5.3.1Street AddressBHF Glasgow Cardiovascular Research Centre, University of Glasgow, 126 University Place
    B.5.3.2Town/ cityGlasgow
    B.5.3.3Post codeG12 8TA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01413303419
    B.5.6E-mailNaveed.Sattar@glasgow.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity of Glasgow
    B.1.3.4CountryUnited Kingdom
    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 supportBoehringer Ingelheim Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Glasgow
    B.5.2Functional name of contact pointProfessor Naveed Sattar
    B.5.3 Address:
    B.5.3.1Street AddressBHF Glasgow Cardiovascular Research Centre, University of Glasgow, 126 University Place
    B.5.3.2Town/ cityGlasgow
    B.5.3.3Post codeG12 8TA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01413303419
    B.5.6E-mailNaveed.Sattar@glasgow.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 Jardiance
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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 nameJardiance
    D.3.4Pharmaceutical form Film-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 INNEmpagliflozin
    D.3.9.1CAS number 864070-44-0
    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 placeboFilm-coated 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
    Chronic heart failure with left ventricular systolic dysfunction
    E.1.1.1Medical condition in easily understood language
    Heart failure
    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 LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019279
    E.1.2Term Heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To examine the effect of empagliflozin on heart structure and function (as measured by MRI scan of the heart) in patients with type 2 diabetes mellitus (or prediabetes) and heart failure.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:

    To examine the effect of empagliflozin on:
    • microvascular perfusion and extracellular volume fraction (Gd-CMR),
    • quality of life scores,
    • exercise capacity
    • laboratory tests (heart, kidney, endocrine)
    pulmonary congestion (lung ultrasound)

    To examine the effect of empagliflozin on safety including liver injury, renal failure, high potassium, and pH imbalance (metabolic acidosis).

    Experimental Secondary Objectives (may not be completed for all patients):
    • To examine the effect of empagliflozin on myocardial metabolic activity defined by PCr:ATP ratio at 31P MR spectroscopy (substudy)
    • To examine the effect of empagliflozin on total and regional renal blood flow using CMR

    Research Only Objectives:
    • To examine the effect of empagliflozin on biomarker profile
    • To examine the effect of empagliflozin on DNA and epigenetics
    • To examine the effect of empagliflozin on Bioelectrical Impedance Analysis (BIA)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The sub-study is included in the study protocol and therefore matches version and date of this (V3.0, 23.08.2018). The sub-study is basically an experimental secondary objective 'To examine the effect of empagliflozin on myocardial metabolic activity defined by PCr:ATP ratio at 31P MR spectroscopy'.
    E.3Principal inclusion criteria
    Written informed consent

    Male or female, aged ≥18 years age

    Type 2 DM (diet-controlled or on stable treatment) or prediabetes
    o Stable treatment defined as no change in oral therapy agents or doses for diabetes mellitus and (where applicable) <10% change in average total daily insulin dose over last 6 weeks
    o HbA1c ≤97 mmol/mol (11%) (routine available data from medical records, recorded in the last year)
    o Prediabetes defined as HbA1c 39-47 mmol/mol (5.7-6.4%) at the time of screening (specifically for the prediabetes group, HbA1c will be repeated at the time of screening if there are no recent results within the last 3 months, in order to confirm the diagnosis of prediabetes)

    Heart failure (as defined by presence of typical signs and symptoms of heart failure with documented reduced ejection fraction (ref SIGN and ESC guidelines)):
    o NYHA class II-IV
    o LVEF ≤40%
    o On stable doses of ACEI, ARB or ARNI for 4 weeks prior to randomisation unless contraindicated or not tolerated. They should also be taking a beta-blocker at a stable dose for 4 weeks unless contraindicated or not tolerated.

    Women of childbearing potential must be currently adhering to, or be willing to use, highly effective birth control methods for study treatment duration including:
    o Combined hormonal contraception (oestrogen and progestogen containing medication) either orally, intravaginally, or transdermally
    o Progesterone only hormonal contraception either orally, injected, or implanted
    o Intrauterine device (IUD)
    o Intrauterine hormone release system (IUS)
    o Bilateral fallopian tube occlusion
    o Vasectomised partner
    o Complete sexual abstinence where this is their preferred and usual lifestyle

    WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal, post-menopausal being defined as:
    o Women who have had amenorrhea for ≥ 12 consecutive months (without another medical cause)
    E.4Principal exclusion criteria
    • Type 1 DM
    • History of hospital admission with a diagnosis of diabetic ketoacidosis (DKA)
    • Insulin use within 1 year of diagnosis of diabetes
    • History of acute or chronic pancreatitis and on insulin treatment for diabetes or low residual c-peptide (random non-fasting level of <0.2 nmol/l)
    • eGFR <30 ml/min/1.73m2 (derived using CKD EPI) at the time of randomisation (based on latest available result; kidney function tests will be repeated at the time of screening if there are no recent results: (a) within last 6 months in patients with eGFR >60 ml/min/1.73m2; (b) within last 3 months in patients with eGFR 45-60 ml/min/1.73m2; (c) within last 1 month in patients with eGFR 30-44 ml/min/1.73m2)
    • Persistent/permanent atrial fibrillation/flutter (conditions which significantly impede MRI image interpretability)
    • Acute coronary syndrome, stroke or surgery within 1 month (small type 2 MI in the context of acute HF does not apply)
    • BMI >52kg/m2
    • Liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal (ULN) at the time of screening (based on latest available result; liver function tests will be repeated at the time of screening if there are no recent (within last 6 months) results in patients without known liver disease)
    • Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
    • Any condition outside the cardiovascular and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator’s clinical judgement
    • Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma, adjuvant hormonal therapy for breast cancer and hormone therapy for prostate cancer)
    • Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia) which in the opinion of the investigator are clinically significant
    • Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
    • Any uncontrolled endocrine disorder except Type 2 DM or prediabetes
    • Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
    • Known hypersensitivity to the empagliflozin or excipients
    • Known hypersensitivity to gadolinium
    • Inability to give informed consent
    • SGLT2 inhibitor use (current or previous)
    • Devices or any other contraindication to MRI scans
    • Currently pregnant, planning pregnancy, or currently breastfeeding
    • History of previous lower limb amputation (non-traumatic)
    • Current participation in another interventional medical study or within the last 90 days
    • Anyone who, in the investigators’ opinion, is not suitable to participate in the trial for other reasons.
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary outcomes:

    Cardiac Structure: To examine the effect of empagliflozin on left ventricular end-systolic volume index (LVESVI) by cardiac magnetic resonance imaging on active treatment versus placebo.

    Cardiac Function: To examine the effect of empagliflozin on left ventricular global longitudinal strain by cardiac magnetic resonance imaging on active treatment versus placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0, week 36 and week 40 (optional).
    E.5.2Secondary end point(s)
    Secondary Objectives:
    • To examine the effect of empagliflozin on microvascular perfusion and extracellular volume fraction (Gd-CMR)
    • To examine the effect of empagliflozin on quality of life score
    • To examine the effect of empagliflozin on exercise capacity
    • To examine the effect of empagliflozin on biomarker profile
    • To examine the effect of empagliflozin on safety outcomes including hepatic injury, renal dysfunction, hyperkalaemia and metabolic acidosis
    to examine the effects of empagliflozin on pulmonary congestion (lung ultrasound)

    Experimental Secondary Objectives (may not be completed for all patients):
    • To examine the effect of empagliflozin on myocardial metabolic activity defined by PCr:ATP ratio at 31P MR spectroscopy (substudy)
    • To examine the effect of empagliflozin on total and regional renal blood flow using CMR

    Research Only Objectives:
    • To examine the effect of empagliflozin on biomarker profile
    • To examine the effect of empagliflozin on DNA and epigenetics
    • Bioelectrical impedance analysis
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 0, week 12 (except CMR and MR spectroscopy), week 36 and week 40 (optional).
    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 Yes
    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) Yes
    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 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.8.2.4Number 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Planned:
    • Planned sample size achieved, and LVLS

    Unplanned (i.e. early termination):
    • Insufficient funding to support further recruitment, and no reasonable prospect of additional support being obtained
    • New information makes it inappropriate to continue to randomise patients to one or other arm of trial
    • Recruitment is so poor that completion of the trial cannot reasonably be anticipated
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days1
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 100
    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)
    All participants will stop study medicine after visit 4 (after 36 weeks of treatment). There is a final study visit at week 40. At the end of the study, the study medication may not be available to all participants, due to restrictions around prescribing empagliflozin. However, the clinical care team can discuss the best treatment strategy for each patient. Adverse events and reactions will be recorded, reported and followed up until study completion or until 30 days after last dose of IMP.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-12
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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