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    Summary
    EudraCT Number:2016-001264-11
    Sponsor's Protocol Code Number:UMCM-2016EPI05
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-001264-11
    A.3Full title of the trial
    A phase IV, single-center, randomized, double-blind, placebo-controlled, parallel group study on the effects of empagliflozin on left ventricular diastolic function compared to usual care in individuals with type 2 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of empagliflozin on heart function compared to usual care in individuals with type 2 diabetes
    A.3.2Name or abbreviated title of the trial where available
    EmDia
    A.4.1Sponsor's protocol code numberUMCM-2016EPI05
    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 of the Johannes Gutenberg-University Mainz
    B.1.3.4CountryGermany
    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 supportBoehringer Ingelheim Pharma GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center of the Johannes Gutenberg-University Mainz
    B.5.2Functional name of contact pointPhilipp Wild
    B.5.3 Address:
    B.5.3.1Street AddressLangenbeckstr. 1
    B.5.3.2Town/ cityMainz
    B.5.3.3Post codeD-55131
    B.5.3.4CountryGermany
    B.5.4Telephone number00496131177163
    B.5.5Fax number00496131178460
    B.5.6E-mailphilipp.wild@unimedizin-mainz.de
    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® 10mg Filmtabletten
    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.3.1Product nameJardiance® 10mg Filmtabletten
    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
    Poorly controlled type 2 diabetes mellitus in adults
    Schlecht eingestellter Diabetes mellitus Typ2 bei Erwachsenen
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus in adults
    Diabetes mellitus Typ2 bei Erwachsenen
    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
    The primary objective of the trial is to investigate if 12 weeks oral empagliflozin treatment in addition to standard diabetes therapy or dietetic treatment improves the cardiac diastolic function in individuals with type 2 diabetes mellitus.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the trial include assessment of the effects of empagliflozin treatment on the change from baseline to the follow-up visits after 1 week and 12 weeks (Δ) for the following parameters:
    - Left ventricular diastolic function after 1 week
    - Left ventricular systolic function
    - Left end-diastolic volume (LEDV)
    - Arterial stiffness
    - Vascular dysfunction
    - Humoral biomarker
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting all of the following criteria at visit 0 (screening) will be considered for enrollment to the trial:
    - Diagnosis of type 2 diabetes mellitus with stable glucose-lowering background therapy and/or dietetic treatment for at least 12 weeks
    - In subjects without glucose-lowering background therapy: the application of Metformin was considered to be unsuitable due to drug intolerance
    - HbA1c level of ≥ 6.5 % and ≤10.0% for subjects on antidiabetic background therapy or HbA1c level of ≥ 6.5 % and ≤9.0% for drug-naïve subjects with dietetic treatment
    - Diastolic cardiac dysfunction with E/E’ ratio ≥ 8 (2D-echocardiography)
    - Age 18 – 84 years
    - BMI ≤ 45 kg/m² (Body Mass Index) (at visit 0 and/or visit 1)
    - For women: post-menopausal for more than 12 months without an alternative medical cause can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (serum or urine) is available at visit 1 and they are willing to practice highly effective birth control method during trial according to the recommendations of the Clinical Trial Facilitation Group (1). Signed and dated informed consent of the subject must be available before start of any specific trial procedures which is consistent with ICH-GCP guidelines and local legislation.
    E.4Principal exclusion criteria
    Subjects presenting at least one of the following criteria at visit 0 (screening) will not be enrolled in the trial:
    - Pretreatment with empagliflozin or other SGLT2 inhibitor within the last 3 months
    - Pretreatment with known inducers of UGT enzymes
    - Uncontrolled hyperglycemia with a glucose level > 240 mg/dl (>13.3 mmol/L) after an overnight fast
    - Impaired renal function, defined as eGFR < 45 ml/min/1.73 m² of body-surface-area
    - End-stage renal failure or dialysis
    - Severe hepatic dysfunction, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN)
    - Acute urinary tract infection (UTI)
    - Known acute genital infection (GI)
    - Symptomatic hypotension
    - Hematocrit above the upper limit of the reference range
    - Hypoglycemic tendencies
    - Severe PAD (Fontaine classification Stage IIb - IV)
    - Medical history of cancer and/or treatment for cancer within the last 5 years, subjects with basalioma can be included in the study
    - Medical history of pancreatitis or surgery on pancreas
    - Known ketoacidosis (in the past)
    - Acute febrile disease
    - NYHA classification III – IV
    - Pregnant and/or nursing women at visit 1 (baseline)
    - Acute coronary syndrome, stroke or TIA within the last 2 months
    - Alcohol or drug abuse within the last 3 months that would interfere with trial participation
    - Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial (at visit 0 (screening) or at visit 1 (baseline))
    - Medical condition that does not allow enrollment in the trial at visit 1 (baseline)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this trial is the difference in E/E’ ratio (noninvasive surrogate marker for left ventricular diastolic function (LVEDP) measured by 2D-echocardiography) between 12 weeks after baseline and at baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - after 12 weeks
    E.5.2Secondary end point(s)
    - E/E’ ratio (change from baseline (V1) to 1 week follow-up (2D-echocardiography)
    - E/E’ ratio (change from baseline (V1) to 12 week follow-up (2D-echocardiography) in the subgroup of patients with eGFR 45-59 ml/min/1.73 m²
    - E/E’ ratio (change from baseline (V1) to 12 week follow-up (2D-echocardiography) in the subgroup of patients with HbA1c 6.5% - 6.9%
    - Left ventricular systolic function (LVEF)
    - Left end-diastolic volume (LEDV)
    - Ankle brachial index from baseline to 12 weeks follow-up
    - Carotid-femoral pulse wave velocity (cf-PWV, vascular explorer - calculated)
    - Augmentation index (AIx, vascular explorer)
    - Arterial stiffness index (SI, photo plethysmography)
    - Reflection index (photo plethysmography)
    - Brain natriuretic peptide (BNP)
    - High sensitive troponin I (hs TnI)
    - High sensitive C-reactive protein (hs CRP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints include assessment of the effects of empagliflozin treatment on the changes from baseline (day 1) to the follow-up visits after 1 week and 12 weeks (Δ) for the Parameters listed under E.5.2.
    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 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
    last visit of the last subject (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    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: 39
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 119
    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 state158
    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 visit 1, visit 2 and visit 3 the participant will be informed about the medically relevant results of examination by the investigator and receives a comprehensive report on his/her findings to discuss them with his/her general practitioner and/or medical specialist. Treatment after the end of the trial is up to the decision of the general practitioner and/or medical specialist of the participants.
    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 Decision2016-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
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