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    Summary
    EudraCT Number:2021-000667-74
    Sponsor's Protocol Code Number:CV006
    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:2021-10-22
    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 number2021-000667-74
    A.3Full title of the trial
    The effect of bile acid binding with colesevelam on postprandial glucose concentrations in patients after RYGB and cholecystectomy : a meal test study
    Het effect van galzuurbinding met Colesevelam op glucose waarden in het bloed bij patiënten die een gastric bypass en een galblaasoperatie hebben gehad: een maaltijd test
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of bile acid binding with colesevelam on blood sugar levels in patients after gastric bypass surgery and galbladder surgery : meal test study
    Het effect van galzuurbinding met Colesevelam op glucose waarden in het bloed bij patiënten die een gastric bypass en een galblaasoperatie hebben gehad: maaltijd test
    A.3.2Name or abbreviated title of the trial where available
    Colesevelam hypOglycemia Bile acid binding in Rygb : a meAl test study : COBRA
    A.4.1Sponsor's protocol code numberCV006
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00009249
    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 SponsorMedisch Centrum Leeuwarden BV
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportstichting CON-VOLUME research
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical Center Leeuwarden
    B.5.2Functional name of contact pointMedical Center Leeuwarden
    B.5.3 Address:
    B.5.3.1Street AddressH.Dunantweg 2
    B.5.3.2Town/ cityLeeuwarden
    B.5.3.3Post code8934AD
    B.5.3.4CountryNetherlands
    B.5.6E-mailCON-Wetenschappelijkonderzoek@mcl.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 Cholestagel
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme
    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 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.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
    Post Bariatric Hypoglycemia
    post bariatrie hypoglycaemie
    E.1.1.1Medical condition in easily understood language
    development of low blood sugar levels after gastric bypass surgery and galbladder surgery
    lage bloedsuikers (hypoglycaemie) welke ontstaan na een maagverkleiningsoperatie en galblaasoperatie
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10059038
    E.1.2Term Postprandial hypoglycemia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of the bile acid sequestrant colesevelam on glucose concentrations during a liquid meal test (MMT) in patients after RYGB with a previous cholecystectomy (CCx)
    onderzoek naar het effect van de galzuurbinder colesevelam op glucose concentraties tijdens een maaltijd test bij patiënten die zowel een RYGB als een cholecystectomie hebben ondergaan
    E.2.2Secondary objectives of the trial
    measurement of (GI)-hormones (insulin, GLP-1, PYY, FGF19) and bile acids and glucose flux during the MMT with and without bile acid binding with colesevelam
    meting van gastro-intestinale hormonen (insuline, GLP-1, PYY) en glucose flux tijdens de maaltijd test met en zonder galzuur binding met colesevelam
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    patients 20-60 years, 2 years or more after RYGB and with a history of a cholecystectomy
    patienten tussen 20 en 60 jaar, die minimaal 2 jaar terug een RYGB hebben gehad en in het verleden ook een cholecystectomie
    E.4Principal exclusion criteria
    known with post bariatric hypoglycemia
    (former) diabetic
    hypertriglyceridemia
    renal or liver disease
    addiction behaviour
    medication use that will be interfered ith by colesevelam
    pregnancy (planning)
    bekend met post bariatrie hypoglycaemie
    (ex-) diabetes
    hypertriglyceridemie
    nier- of leverziekten
    verslavingsgedrag
    gebruik van medicatie welke beïnvloed kan worden door colesevelam
    zwangerschap(plannen)
    E.5 End points
    E.5.1Primary end point(s)
    Glucose nadir during the MMT in mmol/L
    laagste glucose waarde tijdens de MMT in mmol/L
    E.5.1.1Timepoint(s) of evaluation of this end point
    between time zero and 180 minutes after the start of the MMT
    tussen 0 en 180 minuten na start van de MMT
    E.5.2Secondary end point(s)
    During the MMT :
    Number of patients with a hypoglycemic episode (glucose < 3.0 mmol/L)
    Glucose Area under the curve between 0-60, 60-120 and 60 to 180 minutes (glucose AUC0-60, AUC60-120, AUC60-180min),
    Bile acids and derivatives, GLP-1, PPY, FGF-19, and insulin, both as peaks and as AUC0-60 min .
    Glucose kinetics (absorption rate, endogenous glucose production) using stable isotope dilution of glucose
    tijdens de MMT :
    aantal patiënten met een hypoglycaemie (glucose < 3.0 mol/L)
    glucose area under the curve tussen 0 en 60, 60 en 120 en 60 en 180 minuten (AUC0-60, AUC60-120 en AUC60-180)
    galzouten en derivaten, GLP-1, PYY, FGF19, insuline, pieken en AUC
    glucose kinetiek (absorptie snelheid, distributie en endogene glucoseproductie), gemeten met stabiele isotoop methode
    E.5.2.1Timepoint(s) of evaluation of this end point
    time points have been addressed in the above section
    tijdstippen zijn al hierboven genoemd
    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 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 Yes
    E.8.1.7.1Other trial design description
    de eerste maatijd test is zonder de tweede met colesevelam kort voor start test
    the first meal test followed by a second test with ingestion of colesevelam just before
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    de test wordt niet vooraf gegaan door inname van de colesevelam het studie medicijn
    no medication
    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
    the trial is ended when the last of 20 patients have finished the second MMT
    de studie eindigt wanneer de laatste van de 20 patiënten de tweede MMT heeft afgemaakt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    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: 20
    F.1.3Elderly (>=65 years) No
    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 state20
    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)
    no treatment will be made available for this patient group
    aan de patiënten zal geen specifieke medicatie gegeven worden na einde van de studie
    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 Decision2021-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-11
    P. End of Trial
    P.End of Trial StatusOngoing
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