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    Summary
    EudraCT Number:2020-006127-34
    Sponsor's Protocol Code Number:1.3
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-09
    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 ConcernedAustria - BASG
    A.2EudraCT number2020-006127-34
    A.3Full title of the trial
    Empagliflozin as potential treatment option for postprandial hyperinsulinemic hypoglycaemia after bariatric surgery – a pilot study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Empaglifozin in patients with hypoglycaemia after meal after bariatric surgery - a pilot study
    A.3.2Name or abbreviated title of the trial where available
    n/a
    A.4.1Sponsor's protocol code number1.3
    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 SponsorVerein zur Förderung der Wissenschaft und Forschung an der 1.Med. Abteilung der Krankenanstalt Rudolfstiftung
    B.1.3.4CountryAustria
    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 supportVerein zur Förderung der Wissenschaft und Forschung an der 1.Med. Abteilung der Krankenanstalt Rudolfstiftung
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVerein zur Förderung der Wissenschaft und Forschung an der 1.Med. Abteilung der Krankenanstalt Rudolfstiftung
    B.5.2Functional name of contact pointDr. Bernhard Ludvik
    B.5.3 Address:
    B.5.3.1Street AddressJuchgasse 25
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1030
    B.5.3.4CountryAustria
    B.5.4Telephone number00431711652107
    B.5.6E-mailbernhard.ludvik@gesundheitsverbund.at
    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 Jardiance
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameJardiance
    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 INNEmpagliflozin
    D.3.9.1CAS number 864070-44-0
    D.3.9.3Other descriptive nameEMPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB35915
    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
    Postprandial hyperinsulinemic hypoglycaemia (PHH) typically occurs years after bariatric surgery and one to three hours after a carbohydrate-rich meal. It is caused by rapid gastric emptying of undigested carbohydrates leading to high plasma glucose concentrations and increased incretin release which results in hyperinsulinemia and finally hypoglycaemia. Patients may suffer from fatigue, weakness, confusion, hunger, syncope, perspiration, palpitations or tremor.
    E.1.1.1Medical condition in easily understood language
    PHH may occur after an operation of the stomach as rapid gastric emptying leads to high plasma glucose levels, counter-regulatory high insulin levels and finally hypoglycaemia.
    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
    Primary objective is to assess the efficacy of empagliflozin compared to placebo. It is evaluated whether empagliflozin, as compared to placebo, reduce the frequency and severity of hypoglycaemic episodes in post-bariatric patients suffering from PHH. Therefore, data from CGM, OGTT and MMTT are used. Effects of empagliflozin, as compared to placebo, concerning nadir plasma glucose levels, postprandial plasma peak glucose levels, plasma c-peptide levels and plasma insulin levels will be evaluated. Length of time and amount of glucose needed to restore normoglycaemia will be examined.
    E.2.2Secondary objectives of the trial
    Impact of treatment with empagliflozin on symptoms of PHH will be evaluated by comparing scores of Edinburgh Hypoglycemia Scale, Stanford Sleepiness Scale and Sigstad’s Scoring System between baseline and treatment period.
    Furthermore, the influence of individual characteristics such as sex, age, insulin sensitivity, BMI, comorbidities and concomitant medications on the occurrence of hypoglycemic episodes under a treatment with empagliflozin will be regarded.
    Tolerability of both study drugs regarding side effects will be evaluated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    >= 18 years, <=65 years, no diagnosis of type 2 diabetes mellitus, Time of bariatric surgery > 1 year, No reported hypoglycemic episodes before bariatric surgery, Symptoms of PHH after bariatric surgery
    E.4Principal exclusion criteria
    diabetes mellitus type 1, type 2 or HbA1c ≥ 6.5% or use anti-diabetic drugs or insulin, Use of any drug to treat PHH in the last four weeks (acarbose etc.), Have a current infection, anamnestic necrotising fasciitis, Follow a ketogenic diet, impaired renal function with a eGFR ≤ 60 ml/min/m², recurrent urinary tract infections (≥ 2 episodes during the last year), pyelonephritis (≥1 episode during the last 5 years), urosepsis (≥1 episode during the last 5 years), Known or suspected hypersensitivity to trial product(s) or related products, Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method, Have diagnosed insulinoma, Had reoperation or revision of bariatric surgery , severe gastroparesis, BMI ≤ 18.5 kg/m², severe cardiovascular disease with any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 90 days prior to the day of screening, Subjects presently classified as being in New York Heart Association Class IV, Have acute or chronic hepatitis, signs or symptoms of any other liver disease, or an alanine transaminase (ALT) level ≥3.0 above the upper limit of normal (ULN) for the reference range, as determined by the central laboratory, Have a history of an active or untreated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years, Have a history of any other condition (such as known drug or alcohol abuse or psychiatric disorder) that, in the opinion of the investigator, may preclude the patient from following and completing the protocol, Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study, Have participated, within the last 30 days in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer), should have passed
    E.5 End points
    E.5.1Primary end point(s)
    frequency and severity of hypoglycemic episodes after 12 weeks of intervention with empagliflozin or placebo,
    Primary efficacy measures will be evaluated after 12 weeks of treatment with study drug:
    • Data from CGM; Time in range [27]:
    Time below range (TBR): % of readings and time 54–69 mg/dL – Level 1
    Time below range (TBR): % of readings and time <54 mg/dL – Level 2
    Time in range (TIR): %of readings and time 70–180 mg/dL – In range
    Time above range (TAR): %of readings and time >250 mg/dL – Level 2
    Time above range (TAR): %of readings and time 181–250 mg/dL – Level 1
    • Data from OGTT/MMTT:
    Nadir plasma glucose levels after OGTT/MMTT
    Peak plasma glucose levels after OGTT/MMTT
    Plasma C-peptide levels after OGTT/MMTT
    Plasma insulin levels after OGTT/MMTT
    Nadir GLP-1 levels after OGTT/MMTT
    Maximum GLP-1 levels after OGTT/MMTT
    AUC values for GLP-1 levels after OGTT/MMTT
    • Rescue glucose needed for hypoglycaemic episodes (1 BE = 12 g carbohydrates)
    • Time after glucose administration until normoglycaemia is restored
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoint will be evaluated after 12 weeks
    E.5.2Secondary end point(s)
    Secondary efficacy measures will be evaluated after 12 weeks of treatment:
    • Symptoms of PHH objectified by Edinburgh Hypoglycemia Scale, Stanford Sleepiness Scale and Sigstad’s Scoring System
    • Influence of individual characteristics & anthropometric data on hypoglycaemic episodes (sex, age, weight, BMI, comorbidities, concomitant medications)
    • Tolerability of empagliflozine (number of AE, f.ex. number of genitourinary tract infections)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The endpoint will be evaluated after 12 weeks
    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) 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 Yes
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 60
    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 state60
    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)
    The treatment after trial is done according to the guidelines for patients with bariatric surgery.
    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 Decision2021-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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