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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   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:2009-013668-38
    Sponsor's Protocol Code Number:1245.33
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-11
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2009-013668-38
    A.3Full title of the trial
    A phase IIb, randomised, double-blind, placebo-controlled, parallel group, safety and efficacy study of BI 10773 (10 mg and 25 mg) administered orally, over 78 weeks in type 2 diabetic patients receiving treatment with basal insulin (glargine, detemir, or NPH insulin only) with or without concomitant metformin and/or sulfonylurea therapy and insufficient glycaemic control.
    A.4.1Sponsor's protocol code number1245.33
    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, Lda
    B.1.3.4CountryPortugal
    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 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.3.9.2Current sponsor codeBI 10773
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration 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 nameBI 10773
    D.3.2Product code BI 10773
    D.3.4Pharmaceutical form 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.3.9.2Current 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 placeboTablet
    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 Mellitus
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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 primary endpoint in this study is the change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment. Throughout the study protocol, the term "baseline" refers to the observation at the randomization visit (Visit 3) prior to treatment.
    E.2.2Secondary objectives of the trial
    Key secondary endpoints:
    • Change from baseline in dose of basal insulin dose after 78 weeks of treatment
    • Change from baseline in HbA1c after 78 weeks of treatment

    Secondary endpoints
    • The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <7.0% after 18, 54 and 78 weeks of treatment
    • Occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 18, 54 and 78 weeks of treatment
    • Change from baseline in HbA1c after 54 weeks of treatment
    • Change from baseline in dose of basal insulin dose after 54 weeks of treatment
    • The change from baseline and percent change from baseline in fasting plasma glucose (FPG) after 18, 54, and 78 weeks of treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
    • Male and female patients with a diagnosis of T2DM treated with basal glargine or detemir insulin (≥20 IU/day) or NPH insulin (≥14 IU/day) with or without concomitant metformin and / or sulfonylurea. The total insulin dose should not be changed by more than 10% of the baseline value within the 12 weeks prior to randomization. The oral anti-diabetic therapy has to be unchanged for at least 12 weeks prior to randomization.
    • HbA1c of >7.0% and ≤10% at Visit 1 (screening)
    • Suitability for trial participation according to investigator's judgment (evaluating all
    alternative treatment options and in consideration of the patient completing the study)
    • Age ≥18 years at Visit 1 (screening)
    • BMI ≤45 kg/m2 (Body Mass Index) at Visit 1 (screening)
    E.4Principal exclusion criteria
    Clinical conditions that might interfere with the subject's ability to participate in the trial include, but are not limited to, the following:
    • Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast or >400 mg/dl (>22.2 mmol/L) in a randomly performed measurement during placebo run-in and confirmed by a second measurement (not on the same day).
    • Frequent (at the discretion of the investigator) episodes of hypoglycemic events on
    basal insulin therapy
    • Myocardial infarction, stroke, or Transient Ischemic Attack (TIA) within 3 months
    prior to obtaining informed consent
    • Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST
    (SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal
    ULN) as determined at Visit 1
    • Impaired renal function, defined as GFR <30 ml/min
    • The metformin or sulfonylurea that you’re taking is not being used in accordance with local prescribing information.
    • Any contraindications to the background basal insulin (glargine, detemir, or NPH)
    according to the local label
    • Known hypersensitivity or allergy to the investigational product BI 10773 or its
    excipients
    • Treatment with any other oral anti-diabetic medications, other than metformin and / or sulfonylurea therapy, within 3 months of obtaining informed consent
    • Patients with a history of having received chronic short acting insulin, a
    Glycogen-like peptide – 1 (GLP-1) analogue, or an Amylin agonist, within 3 months
    of signing informed consent
    • Gastric bypass surgery or any other gastrointestinal surgery that may induce
    mal-absorption
    • Treatment with anti-obesity drugs (e.g., including but not limited to sibutramine,
    orlistat, or rimonabant) 3 months prior to informed consent
    • Current treatment with systemic steroids at time of informed consent or change in
    dosage of thyroid hormones within 6 weeks prior to informed consent
    • Patients with history of any cancer within last 5 years with the exception of basal cell and squamous cell skin cancer
    • Pre-menopausal women (last menstruation ≤1 year prior to informed consent) who: are nursing their infant 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
    • Alcohol or drug abuse within the 3 months prior to informed consent that would
    interfere with trial participation
    • Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., hemolytic anemia, thalassemias, sickle cell disease, hemochromatosis with routine phlebotomy treatment, malaria). An accurate HbA1c can not be established in patients with hemolysis
    • Participation in another trial with an investigational drug within 2 months prior to
    informed consent
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is the change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment. Throughout the study protocol, the term "baseline" refers to the observation at the randomization visit (Visit 3) prior to 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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    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) 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) Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Defined in the protocol page 62.
    For all patients a follow-up visit (Visit 12) should be performed via telephone by the
    investigator 7 days post-treatment
    In case of premature discontinuation from the treatment period, at the time of discontinuation complete Visit 11 procedures followed by a telephone visit 7 days post-clinic visit (Visit 12).
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 985
    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)
    It will be the expected normal treatment for that condition.
    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 Decision2009-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-09
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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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