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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-016258-41
    Sponsor's Protocol Code Number:1245.23
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-06
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-016258-41
    A.3Full title of the trial
    A phase III randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg, 25 mg) administered orally, once daily over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulfonylurea
    A.4.1Sponsor's protocol code number1245.23
    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 SponsorBoehringer Ingelheim France
    B.1.3.4CountryFrance
    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 nameBI 10773
    D.3.2Product code BI 10773
    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.3.9.1CAS number 864070-44-0
    D.3.9.2Current sponsor codeBI 10773
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 nameBI 10773
    D.3.2Product code BI 10773
    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.3.9.1CAS number 864070-44-0
    D.3.9.2Current sponsor codeBI 10773
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    The study will be performed in patients (age of 18 or more) with type 2 diabetes and insufficient glycaemic control despite a background therapy of metformin or metformin plus a sulfonylurea.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II 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 current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 mg, 25 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient glycaemic control.
    For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 in type 2 diabetic patients with very poor glycaemic control (HbA1c >= 11 %) for 24 weeks.
    The main endpoint in this study is the change from baseline in HbA&C after 24 weeks of treatment.
    E.2.2Secondary objectives of the trial
    1) Change from baseline in body weight after 24 weeks of treatment

    2) Change from baseline in Mean Daily Glucose after 24 weeks of treatment

    Other exploratory efficacy endpoints:
    - Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after
    24 weeks of treatment
    - Occurrence of relative efficacy response (HbA1c lowering by a least 0.5% after
    24 weeks of treatment
    - Change from baseline in HbA1c by visit over time
    - Change from baseline in waist circumference after 24 weeks of treatment
    - Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
    - Change from baseline in FPG by visit over time
    - Systolic and diastolic blood pressure: Change from baseline to week 24
    - Composite endpoint of the following conditions at week 24: HbA1c lowering by at
    least 0.5% after 24 weeks of treatment; lowering of systolic blood pressure by at
    least 3 mm Hg and decrease in body weight by more than 2%.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    This trial will include a Pharmacogenetic-substudy and a MTT (Meal Tolerance Test)-substudy. These sub-studies are part of the main protocol.
    E.3Principal inclusion criteria
    1. Diagnosis of type 2 diabetes mellitus prior to informed consent
    2. Male and female patients on a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea
    (see below for minimum doses).
    The treatment regimen has to be unchanged for 12 weeks prior to randomisation.
    Minimum dose for metformin: - > or = 1500 mg/day or
    - maximum tolerated dose or
    - maximum dose according to local label
    Minimum dose for sulfonylurea: - > or = half of the maximal recommended dose or
    - maximum tolerated dose or
    - maximum dose according to local label
    3. HbA1c of > or = 7.0% and < or = 11% at Visit 1 (screening) in order to be eligible for randomised treatment
    HbA1c of > 11% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773)
    4. Age > or = 18
    5. BMI < or = 45 kg/m2 (Body Mass Index) at Visit 1 (Screening)
    6. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation
    E.4Principal exclusion criteria
    1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L)
    after an overnight fast during placebo run-in and confirmed by a second
    measurement (not on the same day).
    2. Any other antidiabetic drug within 12 weeks prior to randomisation except those
    mentioned in inclusion criterion 2
    3. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
    4. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST
    (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as
    determined during screening and/or run-in phase
    5. Impaired renal function, defined as GFR<30 ml/min (severe renal impairment) during screening and/or run-in phase
    6. Bariatric surgery within the past two years and other gastrointestinal surgeries
    that induce chronic malabsorption
    7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for
    cancer within the last 5 years
    8. Contraindications to metformin and/or sulfonyurea according to the local label for
    those patients that enter the study with the respective background therapy
    9. Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell
    (e.g.malaria, babesiosis, haemolytic anemia).
    10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to
    informed consent or any other treatment at the time of screening (i.e. surgery,
    aggressive diet regimen, etc.) leading to unstable body weight
    11. Current treatment with systemic steroids at time of informed consent or change
    in dosage of thyroid hormones within 6 weeks prior to informed consent or any
    other uncontrolled endocrine disorder except T2D
    12. Pre-menopausal women (last menstruation 1 year or less 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 tubal ligation, transdermal patch, intra uterine devices/systems
    (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence,
    (if acceptable by local authorities) double barrier method and vasectomised
    partner
    13. Alcohol or drug abuse within the 3 months prior to informed consent that would
    interfere with trial participation or any ongoing condition leading to a decreased
    compliance to study procedures or study drug intake
    14. Participation in another trial with an investigational drug within 30 days prior to
    informed consent
    15.Any other clinical condition that would jeopardize patients safety while
    participating in this clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is the change from baseline in HbA1c after 24 weeks of treatment
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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.8.1.7.1Other trial design description
    One open label arm (25 mg BI 10773) is inlcuded (poorly controlled patients)
    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.8.3 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 concerned18
    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 Yes
    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
    Provided in the protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days15
    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 in some of the participating countries
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state105
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 294
    F.4.2.2In the whole clinical trial 1390
    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 Decision2010-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-03
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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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