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    Summary
    EudraCT Number:2018-002640-82
    Sponsor's Protocol Code Number:EANITIATE1
    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:2018-09-13
    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 number2018-002640-82
    A.3Full title of the trial
    A randomized, controlled, multicentre trial regarding the safety and feasibility of treatment with empagliflozin compared with NPH insulin treatment in patients with newly onset diabetes following initiation of glucocorticoid treatment.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimal treatment of glucocorticoid-induced diabetes.
    A.3.2Name or abbreviated title of the trial where available
    EANITIATE
    A.4.1Sponsor's protocol code numberEANITIATE1
    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 SponsorNordsjællands 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 supportindependent non-commercial foundations
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNordsjællands Hospital
    B.5.2Functional name of contact pointPeter Lommer Kristensen
    B.5.3 Address:
    B.5.3.1Street AddressDyrehavevej 29
    B.5.3.2Town/ cityHillerød
    B.5.3.3Post code3400
    B.5.3.4CountryDenmark
    B.5.6E-mailpeter.lommer.kristensen.01@regionh.dk
    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 International GmbH
    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.3.4Pharmaceutical form
    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 number25
    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 Insulatard
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN HUMAN
    D.3.9.1CAS number 11061-68-0
    D.3.9.3Other descriptive nameInsulatard
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 50
    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
    Diabetes Mellitus that is induced by the use of glucocorticoids
    E.1.1.1Medical condition in easily understood language
    Diabetes due to the use of steroid hormones
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012628
    E.1.2Term Diabetes steroid-induced
    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 determine if empagliflozin can be used as a safe alternative to NPH insulin in patients with GIDM, with a tolerated significant difference in mean daily glucose (mean of CGM measurements) of up to 3mmol/L to the higher side.
    E.2.2Secondary objectives of the trial
    To determine if Empagliflozin is non-inferior compared with NPH insulin in treating GIDM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1.Written signed informed consent prior to any study specific procedures
    2.Recent (within a week) diagnosis of GIDM (defined as non-fasting plasma glucose measured > 11.1 mmol/l at two different occasions, OR at one occasion above 11.1 mmol/L with classical hyperglycaemia symptoms, OR a fasting plasma glucose of >7 mmol/L).
    3.Hospitalized at the time of screening.
    4.Patients >18 years at the time of consent.
    5.eGFR ≥ 60 ml/min/1.73 m2 (estimated by CKD-EPI formula) at visit 1
    6.Female patients must use contraception. The following contraceptives are considered as safe contraception in drug trials: Intra-uterine-device or hormonal contraception (birth control pills, implant, transdermal patch, vaginal ring or depot injection). Sterile or non-fertile subjects are exempted from the requirement for contraception. In order to be considered sterile or non-fertile, one must generally be surgically sterilized (bilateral oophorectomy or hysterectomised at least six months prior to screening) or be postmenopausal, defined as non-menstrual period for at least 12 months before studying. For some individuals or special populations, there may be relationships that speak against the use of the above methods. Examples may be severely impaired hospitalized patients. Such an assessment is taken by the investigator and is his responsibility
    7.Must be able to communicate with the study personnel.

    E.4Principal exclusion criteria
    Exclusion criteria
    1.Known diabetes (treated or not treated) prior to initiation of glucocorticoid treatment.
    2.Use of any blood glucose-lowering medication for the last 30 days prior to the trial for any reason, except up to 2 doses of insulin prior to screening
    3.Hyperglycaemia with a glucose level >20mmol/L
    4.Any former or ongoing pancreatic disorder.
    5.Known or suspected hypersensitivity to trial product(s) or products with the same content/known cross-reactivity.
    6.Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods.
    7.The receipt of any investigational product 30 days prior to this trial
    8.Known or suspected abuse of alcohol or drugs.
    9.Suspected non-compliance with the protocol (as judged by the investigator).
    10.Involvement in the planning/or conduct of the study
    11.Previous randomisation in the study
    12.Participation in another study with an investigational product during the last 30 days prior to enrolment
    13. Age > 85 years.
    E.5 End points
    E.5.1Primary end point(s)
    Mean glucose difference between the empagliflozin and NPH insulin group (calculated mean of CGM glucose profiles over the 2 first weeks of treatment). The data will be downloaded directly from the patients CGM sensors. For calibration purposes capillary glucoses are to be taken: 1) morning fasting and 2) postprandial dinner. The values will be written down by the patient in a study diary. 70 % of possible data (10 out of 14 days) should be available for the patient to be included in the statistical analysis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This endpoint will be evaluated after the end of the trial period which is a minimum of 30 days after inclusion.
    E.5.2Secondary end point(s)
    Between group differences in Time spent In Range (TIR)
    Between group differences of time glucose is above range
    Between group differences of time glucose is below range
    Between group differences in AUC for blood glucose during periods when blood glucose levels reach hyperglycemia level 1 2 and 3*.
    Between group differences in AUC for blood glucose during periods when blood glucose levels reach hypoglycemia level 1 and 2*.
    Between group differences in mean daytime blood glucose levels
    Between group differences in mean nocturnal blood glucose levels
    Between group differences in eHBA1c
    Between group differences in SD of 24-hour blood glucose values
    Between group differences in the SD of daytime blood glucose values
    Between group differences in SD of nocturnal blood glucose values
    Between group differences of MAGE (mean amplitude of glycemic excursions)
    Between group difference in glucose variability measured by the coefficient of variation (CV)
    Between group differences in number of hypoglycemic events* in total and divided into levels and nighttime/daytime
    Between group differences in number of hyperglycemic events* in total and divided into levels and nighttime/daytime
    Number of patients in each group that reach a daily mean glucose level of 6-12 mmol/L during treatment for at least 7 out of the first 14 days of treatment. Outcome measure: CGM and SMBG mean glucose levels
    Mean plasma glucose difference between the empagliflozin and NPH insulin group
    Number of events of mild hypoglycaemia and severe hypoglycaemia (need for third party assistance to restore blood glucose)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The endpoints will be evaluated after the end of the trial period which is a minimum of 30 days after inclusion.
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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 ( follow-up up to 1 year by patient records)
    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: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state74
    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)
    If the patient is well regulated on the trial medication, the patient can stay on the medication under supervision from the local diabetes team or General practitioner. Otherwise the patient will be treated according to local guidelines
    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 Decision2018-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-01-06
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