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    Summary
    EudraCT Number:2014-002370-36
    Sponsor's Protocol Code Number:49690
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-02-03
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-002370-36
    A.3Full title of the trial
    Randomized, double-blind, placebo-controlled trial of the effectiveness and
    safety of dapagliflozin on blood glucose control during glucocorticoid
    treatment for acute exacerbation COPD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Glucose Control during glucocorticoid therapy in acute exacerbation of chronic obstructive pulmonary disease
    Behandeling van hoge bloedsuiker tijdens gebruik van glucocorticoïde medicijnen
    voor een exacerbatie COPD
    A.3.2Name or abbreviated title of the trial where available
    GluCon-COPD
    A.4.1Sponsor's protocol code number49690
    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 SponsorSlotervaart Hospital
    B.1.3.4CountryNetherlands
    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 supportAstraZeneca
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSlotervaart hospital
    B.5.2Functional name of contact pointM.C. Gerards
    B.5.3 Address:
    B.5.3.1Street AddressLouwesweg 6
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066 EC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31205125429
    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/AstraZeneca EEIG
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 INNDapagliflozin
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeForxiga
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB31650
    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
    Glucocorticoid induced hyperglycemia
    Glucocorticoid geinduceerde hyperglycemie
    E.1.1.1Medical condition in easily understood language
    High blood glucose induced by glucocorticoid therapy
    Hoge bloedsuiker als gevolg van glucocorticoïde medicijnen
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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 purpose of this study is to investigate the effectiveness and safety of dapagliflozin for glucose control in patients with exacerbation COPD on high dose glucocorticoids.
    Het doel van de studie is om de effectiviteit en veiligheid van dapagliflozin te onderzoeken, bij patiënten met glucocorticoïd geïnduceerde hyperglycemie tijdens een exacerbatie COPD
    E.2.2Secondary objectives of the trial
    To investigate the efficacy of dapagliflozin on patient satisfaction, clinical outcomes and various outcomes of glucose control and safety (other than the primary outcomes).
    Onderzoeken van patiënttevredenheid, klinische uitkomsten en verschillende maten van glucose controle en veiligheid (anders dan de primaire uitkomsten).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years and ≤100 years at baseline
    - Informed consent
    - Hospitalization due to AECOPD
    - Treatment with ≥30mg prednisone daily or equivalent dose of glucocorticoid for AECOPD
    - An expected duration of glucocorticoid treatment of 3-14 days at study entry
    - Known type 2 diabetes or glucose ≥ 10 mmol/l at admission
    E.4Principal exclusion criteria
    - Maintenance treatment with systemic glucocorticoids or glucocorticoid treatment started ≥7 days before study entry
    - Need for ICU admission
    - Chronic kidney disease stage G3 (glomerular filtration rate <60ml/minute)
    - Recurrent genital or urinary tract infection
    - Current use of any SGLT-2 inhibiting agent
    - Suspected volume depletion
    - Congestive heart failure functional classification NYHA class IV/IV or instable heart failure
    - Acute stroke within 2 months before inclusion.
    - Recent cardiovascular event: acute coronary syndrome, hospitalisation for unstable angina or coronary revascularisation within 2 months before inclusion
    - Suspected liver disease, confirmed by AST/ALT > 3x ULN or bilirubin >2.0mg/dl (34.2 μmol/l) or serologically proven infection with hepatitis B or hepatitis C
    - Pregnancy or breast feeding
    E.5 End points
    E.5.1Primary end point(s)
    Effectiveness: The difference in mean percentage time spent within glucose target range on 2nd till 7th day of treatment, between the dapagliflozin group and the control group as measured by subcutaneous continuous glucose monitor.
    Target range is defined as fasting glucose 4-7.8 mmol/l and random glucose 4-10 mmol/l according to ADA guidelines for non-critically ill inpatients (20).
    Safety: Incidence rate of hypoglycaemic events per patient-day. A hypoglycaemic event is defined according to Whipple´s criteria (i.e. symptoms known or likely to be caused by hypoglycaemia, interstitial glucose ≤ 3.9 mmol/l continuing until the interstitial glucose is >3.9 mmol/l, relief of symptoms when glucose is raised to normal).
    E.5.1.1Timepoint(s) of evaluation of this end point
    2nd till 7th day of treatment
    E.5.2Secondary end point(s)
    1. Patient satisfaction measured by Diabetes Treatment Satisfaction Questionnaire for inpatients (DTSP-IP) (21) specifically directed at glucose lowering treatment.
    2. Clinical outcomes: duration of hospitalisation, need for intensification of treatment for AECOPD, change in body weight and blood pressure during investigational treatment.
    3. Other parameters of glucose control:
    - Glucose variability by mean amplitude of glycaemic excursion (MAGE)
    - Total daily dose of insulin
    - Mean daily glucose concentration
    - Mean percentage time spent within glucose target range from start till end of treatment
    4. Safety: incidence rate of asymptomatic hypoglycaemia, incidence of genital infections and urinary tract infections, incidence of other adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During complete follow-up
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 23
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state46
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-21
    P. End of Trial
    P.End of Trial StatusOngoing
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