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    Summary
    EudraCT Number:2017-005032-42
    Sponsor's Protocol Code Number:17-162
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-02-10
    Trial results View 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 number2017-005032-42
    A.3Full title of the trial
    Effect of Liraglutide on the Metabolic Profile in Patients with Type 2 Diabetes and Cardiovascular Disease
    Effekt von Liraglutid auf das Stoffwechselprofil in Patienten mit Typ 2 Diabetes und kardiovaskulärer Erkrankung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Liraglutide on the Metabolic Profile in Patients with Type 2 Diabetes and Cardiovascular Disease
    Effekt von Liraglutid auf das Stoffwechselprofil in Patienten mit Typ 2 Diabetes und Herz-Kreislauf-Erkrankung
    A.3.2Name or abbreviated title of the trial where available
    Lirabolic
    A.4.1Sponsor's protocol code number17-162
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1212-8596
    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 SponsorRWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty
    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 supportNovo Nordisk
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital RWTH Aachen
    B.5.2Functional name of contact pointCTC-A
    B.5.3 Address:
    B.5.3.1Street AddressPauwelsstr.30
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52074
    B.5.3.4CountryGermany
    B.5.4Telephone number004924180 80092
    B.5.5Fax number004924180 33 80092
    B.5.6E-mailctc-a-spoqs@ukaachen.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 Victoza
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk
    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 nameLiraglutid
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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 Yes
    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 placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetes Type 2 with existing cardiovascular disease
    Diabetes Typ 2 mit bestehender kardiovaskulärer Erkrankung
    E.1.1.1Medical condition in easily understood language
    Diabetes Type 2 with existing cardiovascular disease
    Diabetes Typ 2 mit bestehender Herz-Kreislauf-Erkrankung
    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
    Effect of Liraglutide treatment for 3 months vs. placebo on metabolic profile of patients with type 2 diabetes and existing cardiovascular disease.
    E.2.2Secondary objectives of the trial
    Effect of Liraglutide treatment for 3 months vs. placebo on left ventricular systolic and diastolic function by echocardiography, energy expenditure and respiratory exchange ratio, the incidence of supraventricular and ventricular arrhythmias (24h holter ECG), systemic low grade inflammation as assessed by cytokine profile and circulating leukocyte populations and microbiome composition in patients with type 2 diabetes and existing cardiovascular disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Type 2 diabetes
    2. Serum levels of HbA1c ≥ 7,0%
    3. Age ≥ 18 years
    4. Patients with existing cardiovascular disease: coronary heart disease, cerebrovascular disease, peripheral vascular disease or chronic kidney disease of stage III or greater or chronic heart failure of NYHA II or III
    5. Written informed consent prior to study participation
    E.4Principal exclusion criteria
    1. Type 1 diabetes
    2. Treatment with GLP-1 receptor agonists or DPP-4 inhibitors within in the last 4 weeks
    3. Patients with familiar or personal history of multiple endocrine neoplasia-type 2 or medullary C-cell cancer
    4. Renal impairment (eGFR < 30 mL/min)
    5. Occurrence of acute vascular events within 6 weeks before screening and randomization
    6. Known or suspected hypersensitivity to Liraglutide
    7. Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
    8. Lactating females
    9. The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
    10. The subject received an investigational drug within 30 days prior to inclusion into this study.
    11. The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study.
    12. The subject is unwilling or unable to follow the procedures outlined in the protocol.
    13. The subject is mentally or legally incapacitated.
    E.5 End points
    E.5.1Primary end point(s)
    Effect of Liraglutide 1.8 mg/d in comparison to placebo after 3 month on the metabolic profile using the discovery HD4 platform, which consists of 4 different methods: 2 separate reverse phase (RP)/UPLC-MS/MS with positive ion mode electrospray ionization (ESI), (RP)/UPLC-MS/MS with negative ESI, and (HILIC)/UPLC-MS/MS with negative ESI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 3 month
    E.5.2Secondary end point(s)
    Effect of Liraglutide in comparison to placebo after 3 months on:
    - change in left ventricular diastolic function between baseline and after 12 weeks as determined by 2D and 3D parameter global Strain Rate E by echocardiography
    - change in left ventricular diastolic function between baseline and after 12 weeks as determined by standardized parameter E/é and left atrial (LA) volume by echocardiography
    - change in left ventricular systolic function by ejection fraction (EF) by echocardiography
    - blood pressure
    - body weight
    - NT-proBNP
    - lipid profile
    - serum levels of glucose, HbA1c, glucagon, insulin, C-Peptide, β-Hydroxybutyrate
    - Heart rate variability (24 h ECG)
    - Resting energy expenditure (measured by indirect calorimetry [CardioCoach CO2])
    - Respiratory Exchange Ratio (measured by indirect calorimetry [CardioCoach CO2])
    - Microbiome analysis by 16S metagenomics sequencing
    - Albumin excretion by 24 h urine collection
    - changes in inflammosome analyses assessed by cytokine array
    - changes in lipidomics analyses, parameters included in the metabolomic profile
    - changes in circulation inflammatory cell composition (flow cytometry analyses, FACS)
    - serum and urine samples in addition to blood mononuclear cell pellets are stored for further analyses
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 3 month
    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 Yes
    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) Yes
    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 years
    E.8.9.1In the Member State concerned months24
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state50
    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)
    None
    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 Decision2020-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-12-15
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