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    Summary
    EudraCT Number:2009-016258-41
    Sponsor's Protocol Code Number:1245.23
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-23
    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 ConcernedSlovenia - JAZMP
    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 with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulfonylurea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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 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 No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBoehringer Ingelheim RCV GmbH & Co KG
    B.1.3.4CountryAustria
    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 RCV GmbH & Co KG
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinres Farmacija d. o. o.
    B.5.2Functional name of contact pointInformacije o kliničnem preskušanju
    B.5.3 Address:
    B.5.3.1Street AddressEinspielerjeva ulica 6
    B.5.3.2Town/ cityLjubljana
    B.5.3.3Post code1000
    B.5.3.4CountrySlovenia
    B.5.4Telephone number38659074 006
    B.5.5Fax number38659074 009
    B.5.6E-mailtjasa.rakovec@clinres.si
    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 No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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) 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.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 No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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) 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
    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.
    E.1.1.1Medical condition in easily understood language
    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.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II 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
    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 > 10 %) for 24 weeks.
    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 = 10% at Visit 1 (screening) in order to be eligible for randomised treatment
    HbA1c of > 10% 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. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), 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 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. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial
    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.5.1.1Timepoint(s) of evaluation of this end point
    The HbA1c will be measured at screening Visit (week -3), Visit 3 (week 0), Visit 4 (week 6), Visit 5 (week 12), Visit 6 (week 18) and Visit 7 (week 24).
    E.5.2Secondary end point(s)
    The first key secondary endpoint is the body weight (kg) change from baseline after 24 weeks. The second key secondary endpoint is the mean daily plasma glucose (MDG) change from baseline after 24 weeks of treatment.
    Other secondary endpoints are:
    Occurrence of a treat to target response, (i.e. an HbA1c under treatment of < 7.0%), occurrence of relative efficacy response (HbA1c lowering by at least 0.5%), change in HbA1c and FPG by visit over time, change in FPG from baseline after 24 weeks, change in waist from baseline after 24 weeks, change in systolic and diastolic blood pressure from baseline to week 24 and composite endpoint of the following conditions at week 24: HbA1c lowering by a least 0.5%, lowering of systolic blood pressure by at least 3 mm Hg and decrease in body weight by more than 2%.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Body weight will be measured at screening Visit (week -3), Visit 3 (week 0) and Visit 7 (week 24).
    Mean daily plasma glucose (MDG) wil be measured at Visit 3 (week 0) and Visit 7 (week 24).
    FPG will be measured at Visit 3 (week 0), Visit 4 (week 6), Visit 5 (week 12), Visit 6 (week 18) Visit 7 (week 24) and Visit 8 (week 25).
    Waist will measured at Visit 3 (week 0) and Visit 7 (week 24).
    Blood Pressure will be measured at screening Visit (week -3), Visit 3 (week 0), Visit 4 (week 6), Visit 5 (week 12), Visit 6 (week 18) Visit 7 (week 24) and Visit 8 (week 25).
    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 Yes
    E.8.1.7.1Other trial design description
    One open label arm (25 mg BI 10773) is included (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.8.2.4Number of treatment arms in the trial3
    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 concerned5
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    China
    France
    Germany
    India
    Korea, Republic of
    Mexico
    Slovakia
    Slovenia
    Taiwan
    Turkey
    United States
    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.1.2.1Number of subjects for this age range: 890
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 294
    F.4.2.2In the whole clinical trial 1390
    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)
    Patients who regularly complete the randomised treatment period of this study will be offered to participate in a double blind extension study with BI 10773 (trial 1245.31) in which they will continue on the medication that they were randomised to in the current study.
    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 Decision2010-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
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