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    Summary
    EudraCT Number:2019-001835-29
    Sponsor's Protocol Code Number:201900231
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-16
    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 number2019-001835-29
    A.3Full title of the trial
    Canagliflozin REnal Distribution Intervention Trial (CREDIT); A feasibility study for the use of 18F-canagliflozin to quantify individual differences in target-site exposure in diabetes patients.
    Een studie naar de haalbaarheid van het gebruik van 18F-canagliflozine om individuele verschillen in doel orgaan expositie te kwantificeren bij diabetes patienten.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in diabetes patients to assess the feasability of using radioactive labeled canagliflozin in investigating difference in drug exposure in target organs between responding and non-responding patients by using PET imaging.
    Een studie bij diabetes patienten naar de haalbaarheid van het gebruik van radioactief gelabeld canagliflozine om individuele verschillen in doel orgaan blootstelling te onderzoeken met behulp van PET scans.
    A.3.2Name or abbreviated title of the trial where available
    CREDIT
    A.4.1Sponsor's protocol code number201900231
    A.5.4Other Identifiers
    Name:Netherlands Trial RegisterNumber:NL7707
    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 Medical Center Groningen
    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 supportZonMw and Diabetes Fonds
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointH.J. Lambers Heerspink
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700 RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031503617859
    B.5.6E-mailh.j.lambers.heerspink@umcg.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 No
    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 name18F-canagliflozin
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCanagliflozin
    D.3.9.1CAS number 842133-18-0
    D.3.9.3Other descriptive nameCANAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB33463
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number4
    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 Yes
    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 Invokana
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International N.V.
    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 nameCanagliflozin
    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 INNcanagliflozin hemihydrate
    D.3.9.1CAS number 842133-18-0
    D.3.9.3Other descriptive nameCANAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB33463
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 300
    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 mellitus
    Type 2 diabetes mellitus
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    Type 2 diabetes mellitus
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term 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
    We hypothesize that the underlying mechanisms of the varying response to a drug in multiple parameters within an individual can be attributed to variability in the causal path between drug administration, drug tissue distribution, and tissue receptor interaction. In this clinical feasibility study we will assess 18F-canagliflozin pharmacokinetic characteristics and determine specific receptor binding, receptor occupancy and optimal scanning time in subjects with type 2 diabetes.
    The main objectives are:
    • To assess canagliflozin target (i.e. receptor) specific binding in vivo
    • To assess receptor occupancy of canagliflozin in vivo
    • To determine optimal scanning time in vivo
    We vermoeden dat het onderliggende mechanisme van de variabele respons op een medicament op verschillende parameters in een individu toegeschreven kan worden aan variatie in de route van toediening van een medicament, de weefselverdeling van het middel en diens interactie met de receptor. In de studie onderzoeken we de haalbaarheid van het gebruik van 18F canagliflozine als PET tracer en bepalen we diens farmacokinetische karakteristieken, receptor specifieke binding, receptor bezetting en het optimale scan protocol bij type 2 diabeten.
    De primaire doelen zijn:
    - bepalen receptor specifieke binding canagliflozine in vivo
    - bepalen receptor bezetting canagliflozine in vivo
    - bepalen optimale scan duur in vivo
    E.2.2Secondary objectives of the trial
    To explore the relationship between canagliflozin disposition and changes in the following parameters: (estimated) Glomerular Filtration Rate, plasma glucose and urine glucose excretion
    Onderzoeken van een relatie tussen canagliflozine blootstelling en verandering in de volgende parameters: eGFR, plasma glucose waarde en urine glucose excretie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Type 2 diabetes
    Age ≥ 40 years <75 years
    Written informed consent
    Type 2 diabetes
    Leeftijd tussen 40 en 75 jaar
    Getekend informed consent
    E.4Principal exclusion criteria
    • Pregnant women and women of child-bearing potential who are not using reliable contraception
    • eGFR < 30 mL/min/1.73 m2
    • Subjects on diuretics are allowed to participate but the dose should be stable for at least 4 weeks prior to screening
    • Subjects already on a SGLT2 inhibitor are allowed to participate, but the drug should be interrupted 1 week prior to the first study day till the end of the second study day
    • Subjects using a sulphonylurea.
    • Established peripheral arterial disease
    • Cardiovascular disease: myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV) < 3 months before inclusion
    • History of hypersensitivity to canagliflozin or another SGLT2 inhibitor
    • Active malignancy
    • Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing
    • History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
    • Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications
    • Severe claustrophobia
    - zwangere vrouwen en vrouwen in vruchtbare leeftijd zonder betrouwbare anticonceptie
    - eGFR < 30 mL/min/1.73 m2
    - diuretica gebruik met gewijzigde dosering in 4 weken voorafgaand aan inclusie
    - gebruik van SGLT2 remmer die niet gestopt kan worden gedurende het onderzoek
    - gebruik van SU derivaat
    - manifest perifeer arterieel vaatlijden
    - cardiovasculair lijden in 3 maanden voorafgaand aan inclusie
    - overgevoeligheid voor SGLT2 remmers
    - actieve maligniteit
    - donatie of verlies van meer dan 400ml bloed in 8 weken voorafgaand aan studie
    - drugs of alcohol misbruik in 12 maanden voorafgaand aan studie
    - medische conditie, chirurgie of medicatie gebruik die significant absorptie, distributie, metabolisme of excretie van medicatie verandert
    - ernstige claustrofobie
    E.5 End points
    E.5.1Primary end point(s)
    The main study parameters are dynamic PET data and images and radiation count measurement, and plasma concentrations of 18F canagliflozin and its metabolites.
    Dynamische PET data, radioactiviteit meting en plasma concentratie 18f canagliflozine en diens metabolieten.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Per subjects 2 90 minutes dynamic PET scans will be performed, starting at the moment of 18F canagliflozin injection. Radiation activity and plasma concentrations of 18F canagliflozin will be measured during the PET scans.
    Plasma concentrations of 'cold' canagliflozin will be measured at time points pre-dose, 15, 25, 40, 60, 100, 150, 180, 210, 270 minutes and 24 h after oral dosing of canagliflozin
    Per persoon zullen 2 90 minuten durende dynamische PET scans verricht worden, startend op het moment van 18F canagliflozine injectie. Gedurende beide PET scans worden radioactiviteit en plasma concentraties van 18F canagliflozine gemeten.
    Plasma concentraties van het 'koude' canagliflozine worden bepaald op tijd punten pre-dose, 15, 25, 40, 60, 100, 150, 180, 210, 270 minuten en 24 h na orale toediening van canagliflozine.
    E.5.2Secondary end point(s)
    The secondary study parameters are plasma and urine glucose levels and (e)GFR.
    plasma en urine glucose waarden en eGFR
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients are asked to collect one urine void at the day of screening and to collect 2 times 24h urine at both study days (ie days at wich the PET scans will be performed). At screening and during both study days a fastend glucose will be measured and during the second PET scan point of care glucose measurements will be taken.
    Patienten wordt gevraagd op de dag van screening een urine portie in te leveren en op beide studie dagen (dwz de beide dagen waarop de PET scans plaatsvinden) 24h urine te verzamelen.
    Op dag van screening en beide studie dagen wordt een nuchtere glucose bepaald en gedurende de 2de PET scan zullen point of care glucose metingen gedaan worden.
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 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 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 Yes
    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 bezoek van laatste patient
    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 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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state9
    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)
    After the trial patients will return to standard of care treatment
    Na afloop van de studie gaan patienten terug naar de reguliere 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 Decision2020-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-01
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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