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    Summary
    EudraCT Number:2017-004709-42
    Sponsor's Protocol Code Number:NL63792.099.17
    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:2018-03-28
    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 number2017-004709-42
    A.3Full title of the trial
    An open-label randomised cross-over study to evaluate the albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes
    Een open-label gerandomiseerde cross-over studie naar het albuminurieverlagende effect van dapagliflozine, exenatide en dapagliflozine+ exenatide bij patienten met diabetes type 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the effect of dapagliflozin, exenatide and their combination on the loss of protein in urine in patients with type 2 diabetes
    Studie naar het effect van dapagliflozine, exenatide en de combinatie van beiden op het verlies van eiwit via de urine bij patienten met diabetes type 2
    A.3.2Name or abbreviated title of the trial where available
    DECADE
    DECADE
    A.4.1Sponsor's protocol code numberNL63792.099.17
    A.5.4Other Identifiers
    Name:NTRNumber:NTR 6839
    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 SponsorMartini 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 supportAstra Zeneca
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportMartini Hospital
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMartini Hospital
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressPostbus 30033
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9728 NT
    B.5.3.4CountryNetherlands
    B.5.6E-maila.vd.aart@mzh.nl
    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 holderAstra Zeneca
    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.3.1Product nameForxiga
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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.IMP: 2
    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 Bydureon
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    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.3.1Product nameBydureon
    D.3.4Pharmaceutical form Powder and solvent for prolonged-release suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 diabetes
    Diabetes mellitus type 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    Suikerziekte
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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 main objective of this study is to evaluate the albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes and elevated albuminuria (3.5-100 mg/mmol).
    Het bepalen van het albuminurie-verlagende effect van dapagliflozine, exenatide en de combinatie van beiden bij patiënten met diabetes type 2.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess the correlation in albuminuria-lowering response of dapagliflozin and exenatide within each individual, to assess the effect of dapagliflozin, exenatide and their combination on extracellular volume, to evaluate the correlation between change in extracellular volume and effect on albuminuria, to assess the effect of dapagliflozin, exenatide and their combination on blood pressure and weight, and to evaluate the correlation between the pharmacokinetics of dapagliflozin and exenatide and their albumniria lowering effect.
    • De correlatie tussen het albuminurie-verlagende effect van dapagliflozine en exenatide binnen individuen
    • Het effect van dapagliflozine, exenatide en de combinatie op het extracellulair volume
    • De correlatie tussen verandering in extracellulair volume en het effect op de albuminurie
    • Het effect op de fractional lithium excretion
    • Het effect van dapagliflozine, exenatide en de combinatie op bloeddruk en gewicht
    • De correlatie tussen de farmacokinetiek van dapagliflozine en exenatide en hun albuminurie verlagende werking.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Type 2 diabetes
    • HbA1c ≥ 7.5% (58 mmol/mol) and <10% (86 mmol/mol)
    • eGFR > 30 ml/min/1.73m2
    • Albumin:creatinine ratio >3.5mg/mmol and ≤100 mg/mmol
    • Age ≥ 18 years
    • RAS-blockade either by ACEI or ARB, or willingness to start ACEI or ARB treatment
    • Written informed consent
    • Type 2 diabetes
    • HbA1c ≥ 7.5% (58 mmol/mol) and <10% (86 mmol/mol)
    • eGFR > 30 ml/min/1.73m2
    • Albumin:creatinine ratio >3.5mg/mmol and ≤100 mg/mmol
    • Leeftijd ≥ 18 years
    • RAAS-blokkade met ACEI or ARB, of bereidheid hiermee te starten
    • Schriftelijk informed consent
    E.4Principal exclusion criteria
    • Pregnant women and women of child-bearing potential who are not using reliable contraception
    • Cardiovascular disease
    • Uncontrolled blood pressure (office bp > 160/ 100 mmHg)
    • Active malignancy
    • History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension)
    • Use of SGLT-2 inhibitor, GLP1-RA or DPP-4 inhibitor.
    • Lithium use
    • Zwangeren en vrouwen in de vruchtbare leeftijd zonder betrouwbare vorm van anticonceptie
    • Cardiovasculaire aandoeningen
    • Ongecontroleerde hoge bloeddruk (> 160/ 100 mmHg)
    • Maligniteit
    • Autonome dysfunctie (bijv. flauwvallen of klinisch significante orthostatische hypotensie)
    • Gebruik van een SGLT-2 inhibitor, GLP1-RA or DPP-4 inhibitor.
    • Lithium gebruik
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the percentage change from baseline in albumin:creatinine ratio in the first morning void urine.
    % verandering van baseline in albumin:creatinine ratio in de eerste ochtendurine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks
    6 weken
    E.5.2Secondary end point(s)
    • Correlation in albuminuria response with each intervention
    • Change from baseline in extracellular volume
    • Change from baseline in fractional lithium excretion
    • Correlation between change in albuminuria and extracellular volume
    • Change in blood pressure
    • Change in weight
    • Assessment of pharmacokinetic parameters of each intervention
    • Correlatie in albuminurie response binnen individuen
    • Verandering van baseline in extracellulair volume
    • Verandering van baseline in fractional lithium excretion
    • Correlatie tussen verandering in albuminurie and extracellulair volume
    • Verandering in bloeddruk
    • Verandering in gewicht
    • Bepaling van de farmacokinetische parameters van elke interventie
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks
    6 weken
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    Laatste visite van de laatste proefpersoon
    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
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 state17
    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)
    Both during and after the study, patients will visit their own physician according to the standards of care.
    Gedurende en na de studie bezoeken patienten hun eigen (huis)arts en worden behandeld conform standaard zorg.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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