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    Summary
    EudraCT Number:2010-019968-37
    Sponsor's Protocol Code Number:1245.49
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-18
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-019968-37
    A.3Full title of the trial
    Estudio de fase III, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos sobre la seguridad y la eficacia de BI 10773 (10 mg y 25 mg administrados por vía oral una vez al día) durante 52 semanas en pacientes con diabetes mellitus de tipo 2 y control glucémico insuficiente en tratamiento con una pauta de múltiples inyecciones diarias (MID) de insulina en monoterapia o con metformina
    A phase III, randomized, double-blind, placebo-controlled, parallel
    group safety and efficacy study of BI 10773 (10 mg and 25 mg
    administered orally once daily) during 52 weeks in patients with type 2
    diabetes mellitus and insufficient glycemic control on MDI insulin
    regimen alone or with metformin.
    A.4.1Sponsor's protocol code number1245.49
    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 España, S.A.
    B.1.3.4CountrySpain
    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.3.9.2Current 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.3.9.2Current 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
    Diabetes mellitus tipo 2.
    Type 2 diabetes mellitus
    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
    El objetivo del estudio actual es investigar la seguridad y eficacia del tratamiento con BI 10773 con dos dosis (10 mg diarios y 25 mg diarios) frente a placebo administradas durante 18 y un máximo de 52 semanas como tratamiento complementario a insulina en monoterapia o insulina en combinación con metformina en pacientes con DMT2 con control glucémico insuficiente.
    The objective of the current study is to investigate the safety and efficacy of the BI 10773 treatment with two doses (10 mg q.d. and 25 q.d.) versus placebo given for 18 and 52 weeks as add-on therapy to insulin alone or in combination with metformin in patients with T2DM with insufficient glycemic control.
    E.2.2Secondary objectives of the trial
    No aplica.
    Not applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Diagnóstico de DMT2 antes de la obtención del consentimiento informado.
    2.Pacientes varones y mujeres que sigan una dieta y realicen ejercicio y estén recibiendo tratamiento con múltiples inyecciones diarias (MID) de insulina en monoterapia o en combinación con metformina de liberación inmediata o prolongada. El tratamiento con insulina deberá incluir tanto insulina basal como insulina prandial. Se permitirá cualquier tipo de insulina basal y de insulina prandial. No se podrá utilizar insulinas premezcladas.
    3. La dosis total de insulina prescrita deberá ser > 60 UI/día en la visita 1 (selección) y no deberá modificarse esta dosis en las 12 semanas previas a la aleatorización en más de un 10% con respecto al valor basal en el momento de la aleatorización (visita 3).
    4.Tratamiento con metformina a una dosis estable:
    Dosis diaria 1.500 mg/día o la dosis máxima tolerada (deberá documentarse) o la dosis máxima según la ficha técnica local
    La dosis de metformina debe mantenerse sin cambios durante las 12 semanas previas a la aleatorización (visita 3).
    5.HbA1c 7.5% y < 10% en la visita 1 (selección)
    6.Edad 18 y < 80 años en la visita 1 (selección).
    7.Índice de masa corporal (IMC) 30 y 45 kg/m2 en la visita 1 (selección).
    8.Consentimiento informado por escrito firmado y fechado obtenido antes de la visita 1 de acuerdo con las normas de buena práctica clínica (BPC) y la legislación local.

    1. Diagnosis of T2DM prior to informed consent.
    2. Male and female patients on diet and exercise regimen who are pre-treated with multiple
    daily injections (MDI) of insulin alone or in combination with immediate or extended
    release metformin. Insulin therapy must include both basal and prandial insulin. Any type
    of basal and any type of prandial insulin are allowed. Pre-mixed insulin preparations are
    not allowed.
    3. Total prescribed insulin dose must be >60 IU/day at Visit 1 (screening) and should not be
    changed within 12 weeks prior to randomization by more than 10% from the baseline
    value at randomization (Visit 3).
    4. Stable metformin therapy:
    daily dose 1500 mg/day or maximum tolerated dose (must be documented) or maximum dose according to the local label
    The metformin dose has to be unchanged for 12 weeks before the randomization (Visit 3).
    5. HbA1c >= 7.5% and <= 10% at Visit 1 (screening)
    6. Age >=18 and <= 80 years at Visit 1 (screening)
    7. Body mass index (BMI) >=30 and <= 45 kg/m2 at Visit 1 (Screening)
    8. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation
    E.4Principal exclusion criteria
    1. Hiperglucemia no controlada, con un nivel de glucemia > 240 mg/dl (> 13,3 mmol/l) después de ayuno durante una noche en el periodo de preinclusión con placebo y confirmada mediante una segunda medición (realizada otro día).
    2.Tratamiento, en las 12 semanas previas a la aleatorización, con cualquier otro antidiabético no mencionado en el criterio de inclusión número 2.
    3.Síndrome coronario agudo (IMSEST, IMEST y angina de pecho inestable), ictus o accidente isquémico transitorio (AIT) en los 3 meses previos a la obtención del consentimiento informado.
    4.Signos de enfermedad hepática, definida por unos niveles séricos de alanina transaminasa (ALT, SGPT), aspartato transaminasa (AST, SGOT) o fosfatasa alcalina mayores de 3 veces el límite superior de la normalidad (LSN)
    5.Insuficiencia renal, definida por una filtración glomerular (FG) < 60 ml/min (fórmula del estudio de modificación de la dieta en la enfermedad renal, Modification of diet in renal disease [MDRD]) y medida durante el periodo de selección y/o preinclusión con placebo.
    6.Cirugía bariátrica en los últimos dos años y otras intervenciones quirúrgicas gastrointestinales que induzcan malabsorción crónica.
    7.Antecedentes de cáncer (salvo en caso de carcinoma de células basales) o tratamiento oncológico en los últimos 5 años.
    8.Discrasias sanguíneas conocidas o cualquier otro trastorno que cause hemólisis o eritrocitos inestables (por ejemplo, malaria, babesiosis, anemia hemolítica).
    9.Contraindicaciones a metformina según la ficha técnica local en pacientes incluidos en el estudio con tratamiento con metformina.
    10.Tratamiento con fármacos contra la obesidad (por ejemplo, sibutramina, orlistat) 3 meses antes de la obtención del consentimiento informado o cualquier otro tratamiento en el momento de la selección (es decir, cirugía, régimen dieta agresiva) que ocasione peso inestable.
    11.Tratamiento actual con esteroides sistémicos en el momento de la obtención del consentimiento informado o modificación de la dosis de hormonas tiroideas en las 6 semanas previas a la obtención del consentimiento informado u cualquier otro trastorno endocrino no controlado con excepción de DMT2.
    12.Mujeres premenopáusicas (última menstruación 1 año antes de la obtención del consentimiento informado) que:
    estén en periodo de lactancia o embarazadas, o
    en edad fértil y no utilizan un método anticonceptivo aceptable o no tienen intención de continuar utilizando este método durante todo el estudio y no acceden a someterse a una prueba de embarazo periódica durante su participación en el estudio. .
    13.Consumo de alcohol o drogas en los 3 meses previos a la obtención del consentimiento informado que interferiría en la participación en el estudio o cualquier proceso en curso que ocasionaría un menor cumplimiento de los procedimientos del estudio o de la toma del fármaco de estudio.
    14.Participación en otro estudio con un fármaco en fase de investigación en los 30 días previos a la obtención del consentimiento informado.
    15.Cualquier otra enfermedad clínica que pudiera poner en peligro la seguridad de los pacientes durante su participación en este estudio clínico.


    1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/l) after an
    overnight fast during placebo run-in and confirmed by second measurement (not on the
    same day).

    2. Any other antidiabetic drug within 12 weeks prior to randomization except those mentioned in inclusion criterion 2
    3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or
    transient ischemic attack (TIA) within 3 months prior to informed consent.

    4. Indication of liver disease, defined by ALT, AST, or alkaline phosphatase above 3 times upper limit of normal as determined during screening or run-in period.
    5. Impaired renal function, defined as GFR <60 ml/min (MDRD formula) as determined during screening and/or run-in period
    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. Known blood dyscrasias or any disorders causing hemolysis or unstable red blood cell (e.g. malaria, babesiosis, hemolytic anemia)
    9. Any contraindications to metformin according to the local label for those patients who entered the study with metformin therapy
    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 leading to unstable body weight
    11. Current treatment with systemic steroids a
    E.5 End points
    E.5.1Primary end point(s)
    El criterio principal de valoración en este estudio es el cambio de la HbA1 basal tras 18 semanas de tratamiento.
    The primary endpoint in this study is the change from baseline in HbA1c after 18 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 Yes
    E.6.10Pharmacogenetic No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.2 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Incluido en el protocolo
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 277
    F.4.2.2In the whole clinical trial 555
    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)
    Los pacientes continuarán con tratamiento de referencia.
    Patients will continue with 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 Decision2011-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-22
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