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    Summary
    EudraCT Number:2012-004300-35
    Sponsor's Protocol Code Number:ikfe-Lina-003
    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:2012-12-05
    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 number2012-004300-35
    A.3Full title of the trial
    Effects of Linagliptin on Endothelial- , Renal-, and Retinal Function in Comparison to Placebo in Patients with Hypertension and Albuminuria
    Wirkung von Linagliptin auf Endothel-, Renal- und Retinale Funktionen im Vergleich zu Placebo in Patienten mit Bluthochdruck und Albuminurie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of Linagliptin on Endothelial- , Renal-, and Retinal Function in Comparison to Placebo in Patients with Arterial Hypertension and Albuminuria
    Wirkung von Linagliptin auf Gefäß-, Nieren- und Augenfunktionen im Vergleich zu Placebo bei Patienten mit arteriellen Bluthochdruck und Albuminurie
    A.4.1Sponsor's protocol code numberikfe-Lina-003
    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 SponsorProfil Mainz GmbH & Co KG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisationClinlogix Europe GmbH
    B.5.2Functional name of contact pointContract Research Organisation
    B.5.3 Address:
    B.5.3.1Street AddressBahnhofstraße 8a
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55116
    B.5.3.4CountryGermany
    B.5.4Telephone number+4961313279032
    B.5.5Fax number+4961313279033
    B.5.6E-mailcforkel@clinlogix.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
    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 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 INNTrajenta
    D.3.9.1CAS number 668270-12-0
    D.3.9.3Other descriptive nameLINAGLIPTIN
    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
    Linagliptin in Patients with Hypertension and Albuminuria
    Linagliptin bei Patienten mit Bluthochdruck und Albuminurie
    E.1.1.1Medical condition in easily understood language
    Hypertension and Albuminuria
    arterieller Bluthochdruck und Albuminurie
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10038464
    E.1.2Term Renal hypertension
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10001580
    E.1.2Term Albuminuria
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to investigate the effect of Linagliptin in comparison to placebo on the urine albumin-to-creatinine ratio (UACR) in patients with high blood pressure and an increased albumin excretion.
    Das Ziel dieser Studie besteht in der Erforschung der Wirkung von Linapliptinim Vergleich mit Placebo auf das Albumin-Kreatin-Verhältnis im Urin bei Patienten mit Bluthochdruck und erhöhter Albuminausscheidung
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patient has signed and dated written informed consent to participate in the trial
    2.Arterial hypertension
    3.Stable antihypertensive treatment within the last 3 months
    4.Age ≥ 45 – ≤ 80 years
    5.Micro- or macroalbuminuria defined as UACR in morning urine > 20 mg/g in female and > 30 mg/g in male and/or arterial hypertension for more than 5 years currently treated with two or more antihypertensive drugs to control blood pressure and a history of cardiovascular disease or stroke.
    6.Patient consents that his/her family physician will be informed of trial participation
    1. Unterschriebene Patienteninformation/Einwilligungserklärung
    2. Arterieller Bluthochdruck
    3. Stabile Bluthochdrucktherapie innerhalb der letzten 3 Monate
    4. Alter: ≥45 bis ≤80 Jahre
    5. Mikro- oder Makroalbuminurie (Morgen-UACR >20 mg/g bei Frauen bzw. >30mg/g bei Männern) und/ oder arterieller Bluthochdruck seit mehr als 5 Jahren behandelt mit 2 oder mehr Antihpertensiva zur Bluthochdruckontrolle sowie eine Vorgeschichte Kardiovaskulärer Erkrankungen oder Schlaganfall.
    6. Einwilligung zur Information des Hausarztes.
    E.4Principal exclusion criteria
    1.History of type 1 diabetes
    2.History of type 2 diabetes
    3.Uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg)
    4.Acute infections
    5.Any history of glomerulonephritis
    6.Any kidney disease not caused by hypertension as judged by the Investigator
    7.Glomerular filtration rate (GFR) < 30 ml/min (estimated by use of the Modification of Diet in Renal Disease (MDRD) formula)
    8.Medical history of hypersensitivity to the study drugs or to drugs with similar chemical structures
    9.History of severe or multiple allergies
    10.Treatment with any other investigational drug within 3 months before trial entry
    11.Progressive fatal disease
    12.History of drug or alcohol abuse in the past 2 years
    13.Condition after kidney transplantation
    14.Serum potassium > 5.5 mmol/L
    15.Pregnancy or breast feeding
    16.Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner.
    17.Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 3 months
    18.Any elective surgery during study participation
    19.Uncontrolled unstable angina pectoris
    20.Intake of Coumarin or coumarin derived compounds such as phenprocoumon (Marcumar) or warfarin (Coumadin, Warfant)
    21.Intake of rifampicin or carbamazepine
    22.HbA1c ≥ 6,5%
    23.A Body Mass Index of > 35 kg/m²
    24.CHF NYHA stage III – IV
    1.Diabetes mellitus Typ 1
    2.Diabetes mellitus Typ 2
    3.Unkontrollierter Bluthochdruck (systolisch >180 mmHg bzw. diastolisch >100 mmHg)
    4.Akute Infektionen
    5.Glomerulonephritis
    6.Nierenerkrankung, die nicht durch Bluthochdruck verursacht wurde
    7.GFR < 30 ml/min (MDRD-Formel)
    8.Überempfindlichkeit gegen die Studienmedikation bzw. Medikamente mit chemisch ähnlichen Strukturen
    9.Schwere oder multiple Allergien
    10.Behandlung mit einer anderen Studienmedikation innerhalb der letzten 3 Monate
    11.Progressive tödliche Krankheit
    12.Drogen- oder Alkoholmissbrauch während der vergangenen 2 Jahre
    13.Status post Nierentransplantation
    14.Serum Kalium > 5.5 mmol/L
    15.Schwangerschaft, Stillzeit
    16.Sexuell aktive Frauen ohne sichere Verhütungsmethode (sichere Verhütungsmethoden sind z. B. Hormonimplantat, Pille, Intrauterinpessar, Abstinenz, sterilisierter Partner)
    17.Akuter Myokardinfarkt, Operation am offenen Herzen, zerebrales Ereignis (Schlaganfall, TIA) innerhalb der letzten 3 Monate
    18.Geplanter chirurgischer Eingriff in der Studienzeit
    19.Unkontrollierte instable Angina pectoris
    20.Einnahme von Cumarin bzw. chemisch ähnlicher Substanzen (Phenprocoumon, Warfarin)
    21.Einnahme von Rifampicin or Carbamazepin
    22.HbA1c ≥ 6,5%
    23.BMI > 35 kg/m²
    24.CHF NYHA Stadium III – IV
    E.5 End points
    E.5.1Primary end point(s)
    •Albumin/Creatinine Ratio (UACR) in 24h hour urine under standardized in house condition
    •24 hour urinary sodium excretion under standardized in house condition
    •Fasting cystatin C
    •Fasting serum and urinary neutrophil gelatinase-associated lipocalin (NGAL)
    •Urinary N-acetyl-ß-o-glucosaminidase
    •Urinary nephrin
    •Urinary podocin
    •Fasting cGMP
    •Fasting serum ADMA
    •Fasting hsCRP
    •Fasting TGF-ß1
    •Fasting serum and urinary IL-18
    •Retinal endothelial function
    •Retinal microvascular blood flow
    •24h blood pressure measurements
    •Natriumausscheidung im 24h-Urin
    •Nüchtern Cystatin C
    •Nüchtern Serum und Urin-Werte des Parameters Neutrophil gelatinase-associated lipocalin (NGAL)
    •Urin-Werte des Parameters N-Acetyl-ß-o-Glukosaminidase
    •Urin-Werte des Parameters Nephrin
    •Urin-Werte des Parameters Podocin
    •Nüchtern cGMP
    •Nüchtern Serum ADMA
    •Nüchtern hsCRP
    •Nüchtern TGF ß1
    •Nüchtern Serum und Urinwerte des Parameters IL-18
    •Retinale Endothelfunktion
    •Retinaler mikrovaskulärer Blutfluss
    •24h Blutdruck
    E.5.1.1Timepoint(s) of evaluation of this end point
    after approx. 16 weeks of treatment
    nach ~ 16 Wochen Behandlung
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    exploratorisch, mechanistisch
    exploratory, mechanistic
    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
    After 6 study visits, approx. 16 weeks of treatment
    Nach 6 Studienvisiten, etwas 16 Wochen Behandlung
    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 months11
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state44
    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)
    Special post trial treatment is not planned. Patient will either get back to the routine therapy or will adapt his / her therapy as one of the used medications is available on the German market.
    Eine spezielle Nach-Studien-Therapie ist nicht vorgesehen. Der Patient wird entweder zur seiner Ursprungs-Therapie zurückkehren oder seine Therapie adaptieren, da ein verwendetes Medikament auf dem deutschen Markt erhältlich ist.
    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 Decision2013-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-30
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