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    Summary
    EudraCT Number:2013-004674-97
    Sponsor's Protocol Code Number:MB102-229
    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:2014-11-25
    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 number2013-004674-97
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus
    Ensayo fase 3 multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de dapagliflozina como complemento al tratamiento con insulina en sujetos con diabetes mellitus tipo 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety Study of Dapagliflozin in Type 1 Diabetes
    Estudio de eficacia y seguridad de dapagliflozina en pacientes con diabetes mellitus tipo 1
    A.4.1Sponsor's protocol code numberMB102-229
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1160-6249
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike, PO Box 15437
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post code19850-5437
    B.5.3.4CountryUnited States
    B.5.4Telephone number900 150 160
    B.5.6E-mailinformation.center@astrazeneca.com
    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 nameDapagliflozin
    D.3.2Product code BMS-512148
    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.3.8INN - Proposed INNDapagliflozin
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeBMS-512148
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB31650
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 Diabetes Mellitus
    Diabetes Mellitus tipo 1
    E.1.1.1Medical condition in easily understood language
    Type 1 Diabetes Mellitus
    Diabetes Mellitus tipo 1
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 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 purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes
    El obejtivo de este estudio es determinar si la adición de dapagliflozina a insulina es un tratamiento seguro y efectivo para mejorar el control glucémico en pacientes con diabetes tipo 1.
    E.2.2Secondary objectives of the trial
    - % change in total daily insulin dose and body weight.
    - Change in:
    - mean value of 24-hr glucose readings obtained from CGM
    - mean amplitude of glucose excursion of CGM 24-hr glucose readings
    - % CGM 24-hr glucose readings between > or = 70 and < or = 180 mg/dL
    - Proportion of subjects with A1C reduction > or = 0.5% and no severe hypoglycemia events.
    - % del cambio en la dosis total de insulina y peso corporal
    - Cambio en:
    - valor medio de glucosa obtenido por medición de MCG de 24h
    - amplitud media de las excursiones glucémicas por medición de MCG de 24h
    - % de lecturas de MCG de 24h entre ?70 y ?180 mg/dl
    -Proporción de sujetos con una reducción de A1C ?0,5% y ningún evento hipoglucémico severo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetics Blood Sample Amendment 01 - Site Specific (original version, dated 10-Sep-14)

    The objective of this Amendment is to permit the collection and storage of blood samples for use in future exploratory pharmacogenetic research. Bristol-Myers Squibb is conducting this study on behalf of AstraZeneca. AstraZeneca is the sponsor for the MB102229 study and they will be responsible for the pharmacogenetic portion of this study including the logistically aspects related to this amendment.
    AstraZeneca will use DNA obtained from the blood sample and health information collected from the main clinical trial, MB102229, to study the association between genetic variation and drug response to Dapagliflozin in combination with insulin being used for the treatment of diabetes and also its susceptibility to Type 1 diabetes. AstraZeneca may also use the DNA to study the causes and further progression of Type 1 Diabetes and other Metabolic Diseases. Samples from this study may also be used in conjunction with pharmacogenetic research results from other clinical studies to accomplish this objective.
    Enmienda Número 01 de fecha 10-Septiembre-2014 sobre las muestras de sangre para Farmacogenética:
    El objetivo de esta enmienda es permitir la recogida y almacenamiento de muestras de sangre para su uso en una futura investigación farmacogenética exploratoria. Bristol-Myers Squibb lleva a cabo este estudio en representación de AstraZeneca. AstraZeneca es el promotor del estudio MB 102-229 y será el responsable de la parte farmacogenética de este estudio, incluyendo los aspectos logísticos relacionados con esta enmienda.
    AstraZeneca usará ADN obtenido de muestras de sangre e información de salud recogida del ensayo clínico MB 102-229 para estudiar la asociación entre variaciones genéticas y la respuesta a dapagliflozina en combinación con insulina usada en el tratamiento de la diabetes y también su susceptibilidad a diabetes Tipo 1.
    AstraZeneca podría también usar el ADN para estudiar las causas y posterior progresión de la diabetes tipo 1 y otras enfermedades metabólicas. Las muestras de este estudio podrían usarse junto con resultados de investigación farmacogenética de otros estudios clínicos que compartan este objetivo
    E.3Principal inclusion criteria
    1- Diagnosis of T1DM: Central laboratory test of C-peptide < 0.7 ng/ml
    2- Insulin use for at least 12 months per patient reported or medical records and
    a- Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to the screening visit. Subjects must be on a total insulin dose of >or= 0.3 U/kg/day for at least 3 months prior to the screening visit.
    b- If on MDI insulin administration, subject must be on >or= 3x injections per day.
    3- A1C eligibility criteria include: Screening Visit: Central laboratory A1C >or= 7.7% and <or= 11.0%
    1- Diagnóstico de DMT1: Medición por laboratorio central del péptido C < 0,7 ng/ml
    2- Uso de insulina durante al menos 12 meses según información del paciente o historial médico
    a- El método de administración de insulina (MID o ISCI) no debe haberse modificado al menos 3 meses antes de la visita de selección. Los sujetos deben estar a una dosis total de insulina de ?0,3 U/kg/día al menos 3 meses antes de la visita de selección
    b- Si la forma de administración de insulina es MID, debe ser ? 3 inyecciones por día.
    3- Los criterios de eligibilidad de A1C incluyen: A1C por laboratorio central en la visita de selección: ?7,7% y ?11,0%
    E.4Principal exclusion criteria
    - History of T2DM or maturity onset diabetes of young (MODY), pancreatic surgery, or chronic pancreatitis.
    - Previous use of dapagliflozin and/or any other SGLT-2 inhibitors
    - Use of metformin and/or thiazolidinediones within 2 months prior to the Screening visit
    - Any non-insulin, antihyperglycemic agent, within 1 month prior to the Screening visit
    - History of diabetes ketoacidosis (DKA) requiring medical intervention (eg, emergency room visit and/or hospitalization) within 1 month prior to the Screening visit
    - History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to the Screening visit
    - Frequent episodes of severe hypoglycemia as defined by more than one episode requiring medical assistance, emergency care (paramedics or emergency room care), and/or glucagon therapy administered by a third-party individual within 1 month prior to the Screening visit
    - Antecedentes de DMT2 o diabetes del adulto de inicio juvenil (MODY), cirugía pancreática o pancreatitis crónica
    - Uso previo de dapagliflozina y/o cualquier otro inhibidor de SGLT-2
    - Uso de metformina y/o tiazolidindionas en los 2 meses previos a la visita de selección
    - Cualquier agente antihiperglucémico no insulínico durante el mes previo a la visita de selección
    - Antecedentes de cetoacidosis diabética (CAD) que requiera intervención médica (por ej., visita a urgencias y/o hospitalización) durante el mes previo a la visita de selección
    - Antecedentes de ingreso hospitalario para control glucémico (hiperglucemia o hipoglucemia) durante el mes previo a la visita de selección
    - Episodios frecuentes de hipoglucemia severa definida como más de un episodio que requiere asistencia médica, atención en urgencias (asistencia paramédica o en el servicio de urgencias) y/o tratamiento con glucagón administrado por otra persona durante el mes previo a la visita de selección.
    E.5 End points
    E.5.1Primary end point(s)
    The change in HbA1C from baseline at Week 24
    Cambio en HbA1C desde inicio de tratamiento hasta semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to 24 weeks
    Desde inicio de tratamiento hasta semana 24.
    E.5.2Secondary end point(s)
    %change in total daily insulin dose and body weight

    Change in:
    - mean value of 24-hr glucose readings obtained from CGM
    - mean amplitude of glucose excursion of CGM 24-hr glucose readings
    - % CGM 24-hr glucose readings between >or=70 and <or=180 mg/dL

    Proportion of subjects with A1C reduction >0.5% and no severe hypoglycemia events.
    - % del cambio en la dosis total de insulina y peso corporal
    - Cambio en:
    - valor medio de glucosa obtenido por medición de MCG de 24h
    - amplitud media de las excursiones glucémicas por medición de MCG de 24h
    - % de lecturas de MCG de 24h entre ?70 y ?180 mg/dl
    - Proporción de sujetos con una reducción de A1C ?0,5% y ningún evento hipoglucémico severo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to 24 weeks
    Desde inicio de tratamiento hasta semana 24.
    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 No
    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) 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.8.2.4Number 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 EEA45
    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
    Australia
    Austria
    Belgium
    Canada
    Denmark
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Mexico
    Romania
    Spain
    Sweden
    United Kingdom
    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
    LVLS
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 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: 1674
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 186
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 651
    F.4.2.2In the whole clinical trial 1860
    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)
    At the end of the study treatment period, BMS will not continue to supply study drug to subjects/investigators unless BMS chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under 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 Decision2015-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-25
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