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    Summary
    EudraCT Number:2012-003859-12
    Sponsor's Protocol Code Number:12-027
    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:2013-04-22
    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 number2012-003859-12
    A.3Full title of the trial
    Linagliptin as a modulator of vascular inflammation in patients with type 2 diabetes mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Linagliptin on vascular inflammation in patients with type 2 diabetes mellitus
    Wirkung von Linagliptin auf Gefäßentzündungen bei Patienten mit Diabetes Mellitus (Typ 2)
    A.3.2Name or abbreviated title of the trial where available
    Lina-Plaque
    A.4.1Sponsor's protocol code number12-027
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02077309
    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 for the Medical Faculty, represented by Clinical Trial Center Aachen (CTC-A)
    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 supportUniversity Hospital Aachen , Internal Medicine I
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Center Aachen (CTC-A)
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressPauwelsstraße 30
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52074
    B.5.3.4CountryGermany
    B.5.4Telephone number+492418080092
    B.5.5Fax number+49241803335849
    B.5.6E-mailvdeserno@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 Trajenta 5 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderBoeringer 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 nameTrajenta 5 mg coated tablets
    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 INNLinagliptin
    D.3.9.1CAS number 668270-12-0
    D.3.9.4EV Substance CodeSUB31340
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    patients with type 2 diabetes mellitus and vascular inflammation
    E.1.1.1Medical condition in easily understood language
    To examine the effect of linagliptin versus placebo on vascular inflammation of the carotid artery in patients with type 2 diabetes mellitus.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10061218
    E.1.2Term Inflammation
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term Diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main objective of the present study is to examine the preventative effect of linagliptin 5 mg qd versus placebo on vascular inflammation of the carotic artery by FDG-PET in patients with type 2 diabetes mellitus
    E.2.2Secondary objectives of the trial
    Secondary objectives of the present study are to examine the preventative effect of linagliptin 5 mg qd versus placebo on vessel wall volume of the carotic artery by MRI scan and biomarkers of vascular inflammation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diabetes mellitus Type 2
    - HbA1c > 7%
    - Age > 50 years
    - Coronary artery disease or carotid artery disease
    - 18F-FDG uptake of the carotid arterial wall to background (blood) ratio > 1.8
    - Written informed consent prior to study participation
    - Stable cholesterol lowering medication for the last 3 month
    - Stable anti-diabetic medication for the last 6 weeks which should include a maximal tolerated dose of metformin (unless contraindication or intolerance to metformin does exist)
    - Indication to increase anti-diabetic medication as judged by the investigator
    E.4Principal exclusion criteria
    - Diabetes mellitus type 1
    - Use of DPP-4 Inhibitor and GLP-1 agonists
    - Liver disease (GPT or GOT > 3 times the upper limit of norm) or known liver cirrhosis
    - Any reason for not being able to sustain the imaging studies
    - Pacemaker/ICD/metallic clips in close relation to vessels in the brain
    - Uncontrolled thyroid disease
    - Active malignant disease of any kind with the exception of basalioma
    - Chronic inflammatory disease
    - Chronic use of NSAR or cortisone
    - HbA1c > 10%
    - Patients with a history of pancreatitis
    - Recent (< 6 weeks) clinically significant coronary or cerebral vascular event
    - Indication for coronary artery or cerebral vascular intervention in the next 6 month
    - Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing
    - Lactating females
    - 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.
    - The subject received an investigational drug within 30 days prior to inclusion into this study
    - 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
    - The subject is unwilling or unable to follow the procedures outlined in the protocol
    - The subject is mentally or legally incapacitated
    E.5 End points
    E.5.1Primary end point(s)
    Effect of linagliptin on 18F-fluorodeoxyglucose (FDG) uptake of the carotid arterial wall by positron emission tomography (PET) as depicted by the target-to-background ratio after 6 month of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 month
    E.5.2Secondary end point(s)
    • Effect of linagliptin on magnetic resonance imaging (MRI) plaque burden specified as:
    - wall area
    - wall thickness
    - total vessel area
    - wall area/total vessel area ratio
    - plaque morphology (fibrous cap status, presence of ulcerations, necrotic core volume)
    - plaque perfusion

    based on the average of the right and left carotids after 6 month of treatment

    • Effects of linagliptin on vascular biomarker (high-sensitivity C-reactive protein, interleukin-6, soluble platelet-selectin, soluble E-selectin, soluble intercellular adhesion molecule, vascular cell adhesion molecule (VCAM), endothelin-1, phospholipase A2 (PLA2), matrix metalloproteinase (MMP)-3, MMP-9, adiponectin, myeloperoxidase (MPO), tissue plasminogen activator (TPA), plasminogen activator inhibitor-1 (PAI-1), total GLP-1, active GLP-1 after 3 and 6 month of treatment.

    • Effects of linagliptin on adipose tissue inflammation by 18F-fluorodeoxyglucose (FDG) uptake to the subcutaneous and visceral adipose tissue in addition to expression of inflammatory biomarkers (CD3, CD68, TNFa, IFNg, MCP-1, Adiponectin) in subcutaneous adipose tissue biopsies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 3 and 6 months of treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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) 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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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.
    Patients are treated according to the study protocol and in accordance with the normal standards of medical care.
    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 Decision2013-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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