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    Summary
    EudraCT Number:2012-002278-30
    Sponsor's Protocol Code Number:CRC2012LINA
    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:2012-06-14
    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 number2012-002278-30
    A.3Full title of the trial
    Effects of Linagliptin on Renal Endothelium Function in Patients with Type 2 Diabetes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of Linagliptin on Renal Endothelium Function in Patients with Type 2 Diabetes.
    A.4.1Sponsor's protocol code numberCRC2012LINA
    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 Hospital Erlangen
    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 International GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg, Erlangen
    B.5.2Functional name of contact pointClinical Research Center
    B.5.3 Address:
    B.5.3.1Street AddressUlmenweg 18
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number004991318536245
    B.5.5Fax number004991318539209
    B.5.6E-mailroland.schmieder@uk-erlangen.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 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 nameTrajenta
    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.3.9.3Other 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
    Diabetes mellitus
    E.1.1.1Medical condition in easily understood language
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10012613
    E.1.2Term Diabetes mellitus non-insulin-dependent
    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
    To determine the effect of linagliptin compared to placebo on basal production and release of nitric oxide (NO) from renal vasculature, as assessed by changes of renal plasma flow due to L-NMMA infusion.
    E.2.2Secondary objectives of the trial
    To determine the effects of linagliptin compared to placebo on
    - other renal hemodynamic parameters: RPF, GFR and FF, RVR, calculated intraglomerular pressure.

    - UACR and tubular markers (e.g. NGAL).

    - markers of oxidative stress (e.g. isoprostanes) and inflammation (e.g. hsCRP).

    - metabolic parameters (fasting glucose, fasting insulin, triglycerides, total-, LDL- and HDL-cholesterol)

    To determine the effect of linagliptin compared to baseline on
    - the change of RPF due to L-NMMA-infusion

    - other renal hemodynamic parameters: RPF, GFR and FF, RVR, calculated intraglomerular pressure.

    - UACR and tubular markers (e.g. NGAL).

    - markers of oxidative stress (e.g. isoprostanes) and inflammation (e.g. hsCRP).

    - metabolic parameters (fasting glucose, fasting insulin, triglycerides, total-, LDL- and HDL-cholesterol)

    To determine the relationship between changes of renal endothelial function with metabolic changes and changes of isoprostanes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age between 18 and 70 years
    • Type 2 diabetes without diabetic nephropathy (definition see exclusion criteria)
    • Male and Female patients are eligible. Females of child bearing potential or within two years of the menopause are only eligible if pregnancy test at the screening visit is negative and they use adequate contraceptive precautions during the trial.
    E.4Principal exclusion criteria
    • Any other form of diabetes mellitus than type 2 diabetes mellitus
    • Patients with more than on one blood glucose lowering medication or on one antidiabetic drug that can not be discontinued for the study period.
    • Use of insulin, glitazone or gliptine within the past 3 months
    • Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 6 months prior to study inclusion
    • Urinary albumin excretion (UACR) > 100 mg/g (early morning spot urine)
    • eGFR <45 ml/min/1.73m² (MDRD Formula)
    • Uncontrolled arterial hypertension (RR ≥180/ ≥110mmHg)
    • HbA1c ≥ 10%
    • Fasting plasma glucose ≥ 240 mg/dl
    • Body mass index ≥ 40 kg/m²
    • Triglyceride levels ≥ 1000 mg/dl
    • HDL-cholesterol levels <25 mg/dl
    • Overt congestive heart failure (CHF) or history of CHF
    • Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmakinetics of study drugs
    • Significant laboratory abnormalities such as SGOT or SGPT levels more than 3 x above the upper limit of normal range, serum creatinine > 2mg/dl
    • Drug or alcohol abusus
    • Pregnant or breast-feeding patients
    • Any patient currently receiving chronic (>30 consecutive days) treatment with an oral corticosteroid
    • Patients being treated for severe auto immune disease e.g. lupus
    • Participation in another clinical study within 30 days prior to visit 1
    • Individuals at risk for poor protocol or medication compliance
    • Subject who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change of L-NMMA on renal plasma flow between placebo and linagliptin.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 4 weeks treatment with placebo and linagliptin.
    E.5.2Secondary end point(s)
    - the effects of linagliptin compared to placebo on other renal hemodynamic parameters:
    Renal plasma flow, glomerular filtration rate and filtration fraction, renal vascular resistance, calculated intraglomerular pressure.
    - the effect of linagliptin compared to placebo on urinary albumin creatinine ratio and tubular markers (e.g. NGAL).
    - the effect of linagliptin compared to placebo on markers of oxidative stress (e.g. isoprostanes) and inflammation (e.g. hsCRP).
    - the effect of linagliptin compared to placebo on metabolic parameters (fasting glucose, fasting insulin, triglycerides, total-, LDL- and HDL-cholesterol)
    - the effect of linagliptin compared to baseline on the change of renal plasma flow due to L-NMMA-infusion
    - the effects of linagliptin compared to baseline on other renal hemodynamic parameters:
    Renal plasma flow, glomerular filtration rate and filtration fraction, renal vascular resistance, calculated intraglomerular pressure.
    - the effect of linagliptin compared to baseline on urinary albumin creatinine ratio and tubular markers (e.g. NGAL).
    - the effect of linagliptin compared to baseline on markers of oxidative stress (e.g. isoprostanes) and inflammation (e.g. hsCRP).
    - the effect of linagliptin compared to baseline on metabolic parameters (fasting glucose, fasting insulin, triglycerides, total-, LDL- and HDL-cholesterol)
    - the relationship between changes of renal endothelial function with metabolic changes and changes of isoprostanes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and after 4 weeks treatment with linagliptin and placebo
    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 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 No
    E.8.1.6Cross over Yes
    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 years2
    E.8.9.1In the Member State concerned months0
    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.1.3Elderly (>=65 years) Yes
    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 state65
    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 Decision2012-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-06
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