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    Summary
    EudraCT Number:2022-000157-87
    Sponsor's Protocol Code Number:2022-03
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-01-24
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2022-000157-87
    A.3Full title of the trial
    HypoBar I: Delaying intestinal glucose absorption to ameliorate post-bariatric hypoglycaemia. A randomized cross-over clinical trial.
    HypoBarI: Reduceret risiko for lave blodsukre efter fedmekirurgi ved forsinkelse af tarmens glucoseoptagelse. Et blindet kontrolleret klinisk lodtrækningsforsøg.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HypoBar I: Delaying intestinal glucose absorption to ameliorate post-bariatric hypoglycaemia. A randomized cross-over clinical trial.
    HypoBarI: Reduceret risiko for lave blodsukre efter fedmekirurgi ved forsinkelse af tarmens glucoseoptagelse. Et blindet kontrolleret klinisk lodtrækningsforsøg.
    A.3.2Name or abbreviated title of the trial where available
    HypoBarI
    A.4.1Sponsor's protocol code number2022-03
    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 SponsorHvidovre Hospital
    B.1.3.4CountryDenmark
    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 supportHvidovre Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCarolina Brito Lobato
    B.5.2Functional name of contact pointCarolina Brito Lobato
    B.5.3 Address:
    B.5.3.1Street AddressKettegård Allé 30
    B.5.3.2Town/ cityHvidovre
    B.5.3.3Post code2650
    B.5.3.4CountryDenmark
    B.5.6E-mailcarolina.coimbra.de.brito.lobato@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Glucobay
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameacarbose
    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 INNACARBOSE
    D.3.9.1CAS number 56180-94-0
    D.3.9.4EV Substance CodeSUB07368MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 RoleComparator
    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 NV
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 INNCanagliflozin
    D.3.9.1CAS number 842133-18-0
    D.3.9.4EV Substance CodeSUB33463
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 placeboTablet
    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
    Post-bariatric hypoglycaemia
    E.1.1.1Medical condition in easily understood language
    Low blood glucose in patients submitted to bariatric surgery.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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
    To investigate whether canagliflozin/acarbose therapy is an effective treatment for post-bariatric hypolgycaemia (PBH).
    E.2.2Secondary objectives of the trial
    To explore how chronic treatment with canagliflozin/acarbose modulates the response to a standard meal;
    To clarify if there is a correlation between PBH symptomatology, glycaemic variability and electrocardiographic findings, and whether these are modulated by treatment interventions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At enrolment, participants must:
    • Be adults (above 18 years old);
    • Have undergone bariatric surgery more than 18 months prior to inclusion;
    • Self-reported weight stability (less than 5% variation over the 6 months);
    • Present at least one 5-minutes or longer event of interstitial fluid glucose <3.0 mmol/L, one 5-minutes symptomatic event of IFG<3.9mmol/L (allowing a time gap between symptoms reported and low glucose values of ±30 minutes) at least 4.0% of IFG <3.9mmol/L during a min 10 days CGM monitoring screening period, excluding first 24 hours of monitoring (prone to error due to local inflammatory reaction);
    • Have a negative pregnancy test, if applicable;
    • Commit to safe contraception during the trial and over the following 5 months, namely intrauterine devices, hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections) or double barrier methods (a condom combined with a diaphragm).
    E.4Principal exclusion criteria
    All patients presenting one of the following at enrolment will be excluded:
    • Altered baseline analytical profile, namely an early morning 12h-fasting blood test with hemogram, liver and kidney functions tests, albumin, total proteins, plasma glucose, TSH, insulin, C-peptide, and beta-hCG and thus pointing towards other potential causes for hypoglycaemia and/or prone to unsafety to pursue the trial*;
    • Inability or unwillingness to perform meal test (e.g. unable to have the meal over 20 minutes);
    • Pharmacotherapy that affects glucose metabolism:
    • Glucocorticoid treatment within 6 weeks of inclusion;
    • Somatostatin analogue treatment within 4 months of inclusion;
    • GLP-1 receptor analogue treatment within 6 half-lives of inclusion;
    • SGLT2 inhibitor treatment within 2 weeks of inclusion.
    • HbA1c >47.5 mmol/mol [>6.5%;]
    • Antithyroid treatment within 3 months of inclusion or poorly managed thyroid disease (TSH outside reference range);
    • Pregnancy (positive pregnancy test), aspiring to get pregnant over the following 5 months or lactation;
    • Renal insufficiency (eGFR <60 ml/min/1.73m2);
    • Elevation of liver enzymes (>3 x elevation of upper normal limit of alanine amino transferase and/or alkaline phosphatases);
    • Poorly controlled psychiatric disease or mental retardation;
    • Alcohol or other substance abuse;
    • Significant anaemia (Hb <6.0 mmol/L);
    • Recent history of major adverse cardiovascular events (MACE), such as hospitalizations for heart failure, nonfatal stroke, or nonfatal myocardial infarction within the previous 12 months;
    • Any other condition that in the opinion of the investigator may compromise outcome;
    • Sustained intolerance to study drugs.
    E.5 End points
    E.5.1Primary end point(s)
    o Time under level 1 hypoglycaemia (IFG <3.9 mmol/L or <70 mg/dL) throughout CGM evaluation, comparing treatment intervention A (canagliflozin) and B (acarbose) against treatment intervention C (placebo).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last 10-14 days of each treatment intervention.
    E.5.2Secondary end point(s)
    - Time under level 2 hypoglycaemia (IFG <3.0 mmol/L or <54 mg/dL) throughout CGM evaluation, comparing treatment interventions A and B against C;
    - Postprandial nadir glucose during the meal test, comparing treatment interventions A and B against C;
    E.5.2.1Timepoint(s) of evaluation of this end point
    Last 10-14 days of each treatment intervention.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    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
    Last visit of the last subject undergoing the trial.
    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 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: 16
    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 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 state16
    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 concluding their participation in the study, patients will return to care routines in the outpatient clinic.
    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 Decision2022-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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