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    Summary
    EudraCT Number:2009-013549-27
    Sponsor's Protocol Code Number:1218.62
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-01
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-013549-27
    A.3Full title of the trial
    A randomised double-blind, placebo-controlled, 3 parallel group study investigating the efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily over 12 weeks as add-on therapy to a twice daily dosing regimen of maximal metformin therapy in patients with type 2 diabetes mellitus and insufficient glycemic control
    A.4.1Sponsor's protocol code number1218.62
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSCS Boehringer Ingelheim Comm.V
    B.1.3.4CountryBelgium
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 namelinagliptin
    D.3.2Product code BI 1356 BS
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeBI 1356 BS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    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 No
    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 namelinagliptin
    D.3.2Product code BI 1356 BS
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeBI 1356 BS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 2
    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
    Type 2 diabetes
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    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 the study is to investigate the efficacy and safety of linagliptin
    2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for
    12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily to 5mg once daily and each treatment’s superiority over placebo.
    E.2.2Secondary objectives of the trial
    • Occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 12 weeks of treatment)
    • Change from baseline in HbA1c by visit over time
    • Change from baseline in fasting plasma glucose (FPG) after 12 weeks of treatment
    • Change from baseline in FPG by visit over time
    • Use of rescue therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of type 2 diabetes mellitus prior to informed consent.
    2. Male and female patients, currently treated with metformin alone, or with metformin
    and not more than one other oral antidiabetic drug (antidiabetic therapy may be a
    sulphonylurea, meglitinide, DPP-4 inhibitor or α-glucosidase inhibitor and its dose
    has to be unchanged for 12 weeks prior to informed consent).
    A total daily dose of ≥1500 mg/day metformin divided into twice daily administration
    (e.g., 850 mg bid, 1000 mg bid, 850/1000 mg bid or 500/1000 mg bid) is required for
    inclusion into the trial. A patient taking metformin tid can be included if switched to
    a bid dosing regimen at the time of informed consent. In this case, the total daily dose
    must be maintained (e.g., 500 mg tid to 1000/500 mg bid, 1000/500/500 mg tid to
    1000 bid, 500/500/850 mg tid to 1000/850 mg bid). Patients treated with a total daily dose of metformin of less than 1500 mg (e.g., 500 mg bid) can be included in the trial only if the Investigator has documented that the dose is the maximum tolerated dose for that patient. The total daily dosage of metformin needs to be stable for at least 12 weeks prior to randomisation and throughout the duration of the study.
    3. Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening) fulfils the following
    criteria: For patients undergoing wash out of previous medication: ≥7.0 % to
    ≤9.5 %.. For patients not undergoing wash-out of previous medication: ≥7.0% to
    ≤10.0%.
    4. Glycosylated haemoglobin A1 (HbA1c) ≥7.0 to ≤10.0% at Visit 2 (Start of Run-in).
    5. Age ≥18 and ≤80 years at Visit 1a (Screening).
    6. BMI ≤45 kg/m2 (Body Mass Index) at Visit 1a (Screening).
    7. Signed and dated written informed consent by date of Visit 1a in accordance with
    GCP and local legislation.
    E.4Principal exclusion criteria
    1. Treatment with extended release formulations of metformin within 12 weeks prior to
    consent.
    2. Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) after
    an overnight fast during wash-out/placebo run-in and confirmed by a second
    measurement (not on the same day).
    3. Myocardial infarction, stroke or TIA within 6 months prior to informed consent.
    4. Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST
    (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as
    determined at Visit 1a.
    5. Gastric bypass surgery.
    6. Known hypersensitivity or allergy to the investigational product or its excipients or to
    the trial background therapy (i.e., metformin).
    7. Contraindication to metformin therapy according to local label, for example:
    • Renal disease or renal dysfunction (e.g., as specified by product information of locally approved metformin)
    • Dehydration by clinical judgement of the investigator
    • Acute or chronic metabolic acidosis (present condition in patient history)
    • Hereditary galactose intolerance.
    8. Renal failure or renal impairment (serum creatinine ≥1.5 mg/dL [132 μmol/L]) as
    determined at Visit 1a (Screening).
    9. Treatment with rosiglitazone, pioglitazone, GLP-1 analogues/mimetics or insulin
    within 3 months prior to informed consent.
    10. Treatment with anti-obesity drugs (e.g., sibutramine, orlistat, rimonabant) 3 months
    prior to informed consent.
    11. Alcohol or drug abuse within the 3 months prior to informed consent that would
    interfere with trial participation.
    12. Current treatment with systemic steroids at time of informed consent or change in
    dosage of thyroid hormones within 6 weeks prior to informed consent. However, the
    use of inhaled steroids (e.g., for asthma, COPD) is not an exclusion as these do not
    cause systemic steroid action.
    13. Participation in another trial with an investigational drug within 2 months prior to
    informed consent.
    14. Pre-menopausal women (last menstruation ≥1 year prior to informed consent) who:
    • are nursing or pregnant or
    • are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the
    study and do not agree to submit to periodic pregnancy testing during
    participation in the trial. Acceptable methods of birth control include
    transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral,
    implantable or injectable contraceptives, sexual abstinence and vasectomised
    partner. No exception will be made.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment. Throughout the study protocol, the term "baseline" refers to the last observation prior to the randomised treatment phase.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.2.3.1Comparator description
    2.5 mg BID versus 5 mg QD
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The last visit of the last subject undergoing the trial
    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
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    illiterate patients where allowable according to regulations
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 451
    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)
    standard of 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 Decision2009-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-24
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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