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    Summary
    EudraCT Number:2007-007540-10
    Sponsor's Protocol Code Number:D1690C00006
    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:2008-03-19
    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 number2007-007540-10
    A.3Full title of the trial
    Ensayo en fase III de 24 semanas, internacional, aleatorizado, de grupos paralelos, doble ciego y controlado con placebo, con un período de extensión de 24 semanas, para evaluar la eficacia y la seguridad de la dapagliflozina añadida al tratamiento de los pacientes con diabetes de tipo 2 que tienen un control insuficiente de la glucemia con insulina

    A 24-week international, randomized, parallel-group, double-blind, placebo-controlled Phase III study with a 24-week extension period to evaluate the efficacy and safety of dapagliflozin therapy when added to the therapy of patients with type 2 diabetes with inadequate glycaemic control on insulin.
    A.4.1Sponsor's protocol code numberD1690C00006
    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 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 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 nameDapaglifozin
    D.3.2Product code BMS-512148
    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.3.8INN - Proposed INNDapaglifozin
    D.3.9.2Current sponsor codeBMS-512148
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 nameDapaglifozin
    D.3.2Product code BMS-512148
    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.3.8INN - Proposed INNDapaglifozin
    D.3.9.2Current sponsor codeBMS-512148
    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) 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: 3
    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 nameDapaglifozin
    D.3.2Product code BMS-512148
    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.3.8INN - Proposed INNDapaglifozin
    D.3.9.2Current sponsor codeBMS-512148
    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.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 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029505
    E.1.2Term Non-insulin-dependent 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 primary objective of this study is to assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in subjects with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24.
    E.2.2Secondary objectives of the trial
    Four key secondary objectives are identified a priori for special consideration in this study for each dose of dapagliflozin:
    - to examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to insulin treatment alone after 24 weeks of treatment.
    - to examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to insulin treatment alone after 24 weeks of treatment.
    - to examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of patients with calculated mean daily insulin dose reduction from baseline to week 24 as compared to insulin treatment alone.
    - to examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to insulin therapy alone, from baseline to week 24.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Name of the genetic substudy:
    "A 24-week international, randomized, parallel-group, double-blind, placebo-controlled Phase III study with a 24-week extension period to evaluate the efficacy and safety of dapagliflozin therapy when added to the therapy of patients with type 2 diabetes with inadequate glycaemic control on insulin."

    Date:
    14 December 2007

    Objectives:
    The purpose of the genetic research is to enable future exploratory pharmacogenetic research studies
    E.3Principal inclusion criteria
    Inclusion criteria at enrolment (visit 1):
    1. Provision of a written informed consent
    2. Men and women diagnosed with type 2 diabetes
    3. Age ≥18 - ≤80 years at time of consenting
    4. Patients with inadequate glycaemic control, defined as documented HbA1c ≥7.5%
    and ≤10.5% and who are according to investigators judgement for a period of at
    least 8 weeks prior to enrolment on a stable insulin regimen with a mean insulin
    dose of least 30 IU of injectable insulin per day either without any other OADs or
    with a stable dose of OADs that have been approved in combination with insulin.
    Inclusion criteria before randomisation (visit 2):
    1. Patients with HbA1c ≥7.5% and ≤10.5% according central laboratory values
    measured from sample taken at visit 1 and who are on a stable insulin regimen with
    a mean insulin dose of least 30 IU of injectable insulin per day either without any
    other OADs or with a stable dose of OADs that have been approved in combination
    with insulin.
    2. Daily insulin requirements over the past seven days with insulin dose
    documentation that does not vary more than 10% on more than one occasion of the
    calculated mean daily insulin dose at visit two (For example for patient whose
    calculated mean daily insulin dose at visit 2 is 50 IU, daily doses in the preceding
    seven days with insulin dose documentation may not be <45 and >55 IU on more
    than one occasion).
    3. Women of childbearing potential (WOCBP) must be using an adequate method of
    contraception to avoid pregnancy throughout the study and for up to 4 weeks after
    the study in such manner that the risk of pregnancy is minimized and must have a
    negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent
    units of HCG) within 72 hours prior to the start of study medication. WOCBP include any female who has experienced menarche and who has not undergone
    successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral
    oophorectomy) or is not postmenopausal (defined as amenorrhea ≥12 consecutive
    months; or women on hormone replacement therapy (HRT) with documented serum
    follicle stimulating hormone (FSH) level >35mIU/mL).Even women who are using
    oral, implanted or injectable contraceptive hormones or mechanical products such
    as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to
    prevent pregnancy or practicing abstinence or where the partner is sterile (eg
    vasectomy), should be considered to be of child bearing potential.
    4. Body Mass Index (BMI) ≤ 45 kg/m2
    E.4Principal exclusion criteria
    Exclusion criteria at randomization visit (visit 2):
    1. Clinical diagnosis of type 1 diabetes, MODY or secondary diabetes mellitus (eg
    chronic pancreatitis, partial pancreatectomy).
    2. Symptoms of poorly controlled diabetes that in judgement of the investigator would
    preclude participation in this trial including, but not limited to, marked polyuria and
    polydipsia with greater than 10% weight loss during the 3 months prior to
    enrolment.
    3. History of diabetes insipidus
    4. Use of inhaled insulin or injectable GLP-1 receptor agonists or DPP-4 inhibitors
    within 8 weeks of enrolment visit
    5. Calculated Creatinine Clearance <50 ml/min/1.73m2 (calculated by Cockcroft-Gault
    formula) or a measured serum creatinine value of >2mg/dl (177 ╬╝mol/l). Patients on
    concomitant metformin therapy will be excluded if serum creatinine ≥1.5 mg/dl
    (133 mmol/l) for male subjects and ≥1.4 mg/dl (124 mmol/l) for female subjects
    6. Known condition of congenital renal glucosuria
    7. Total bilirubin >34.2 mmol/l, >2.0 mg/dl (ULN)
    8. Creatine kinase ≥3xULN
    9. Hemoglobin ≤10.0 g/dl (≤100 g/l) for men; hemoglobin ≤9.5 g/dl (≤95 g/l) for
    women
    10. Thyroid-stimulating hormone (TSH) values outside normal range confirmed by
    abnormal T4 values
    11. Positive serologic evidence of current infectious liver disease including patients
    being positive for Hepatitis B viral antibody IgM, Hepatitis B surface antigen and
    Hepatitis C virus antibody.
    12. Any clinically significant abnormality identified on physical examination, ECG or
    laboratory tests, which in the judgement of the investigator would compromise the
    patients’ safety or successful participation in the clinical study.
    13. Significant cardiovascular history within the past 6 months prior to the screening
    visit, defined as: myocardial infarction, unstable angina pectoris, transient ischemic
    attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or
    revascularization (coronary angioplasty or bypass grafts), or cerebrovascular
    accident
    14. Pregnant or breastfeeding patients
    15. Treatment with glucocorticoids equivalent to oral prednisolone >10 mg
    (betametasone >1.2 mg/dexametasone >1.5 mg/hydrocortisone >40 mg)/day within
    30 days prior to enrolment; topical or inhaled corticosteroids are allowed
    16. History of bariatric surgery
    17. Administration of weight loss medication, including but not limited to sibutramine,
    phentermine, orlistat, rimonabant, benzphetamine, diethylpropion,
    methamphetamine, and/or phendimetrazine, within 30 days prior to enrolment
    18. Treatment for Human immunodeficiency virus (HIV)/use of antiviral drugs
    (delavirdine, indinavir, nelfinavir, ritonavir, saquinavir) and/or known
    immunocompromised status, including patients who have undergone organ
    transplantation
    19. Intolerance, contraindication or potential allergy to dapagliflozin or placebo or
    formulation recipients
    20. Congestive heart failure defined as New York Heart Association (NYHA) class III
    or IV (see Appendix D), and/or left ventricular ejection fraction of ≤40%
    21. Severe respiratory failure or severe emphysema
    22. Severe uncontrolled hypertension defined as systolic BP ≥180 mm Hg and/or
    diastolic BP ≥110 mm Hg
    23. Patients who, in the judgment of the investigator, may be at risk for dehydration
    24. History of chronic hemolytic anemia or hemoglobinopathies (sickle cell anemia or
    thalassemias, sideroblatic anemia)
    25. History of alcohol abuse or illegal drug abuse within the past 12 months
    26. History of malignancy within the last 5 years, excluding successful treatment of
    basal or squamous cell skin carcinoma
    27. Involvement in the planning and conduct of the study (applies to both AZ and BMS
    staff or staff at the study centre)
    28. Previous enrolment or randomization to treatment in the present study
    29. Received an investigational agent within 30 days prior to receiving study
    medication
    30. Donation or transfusion of blood, plasma or platelets within the past 3 months prior
    to visit 1
    31. Suspected or confirmed poor protocol or medication compliance as judged by the
    investigator
    32. Severe hepatic insufficiency and/or significant abnormal liver function defined as
    Aspartate aminotransferase (AST) >3 x upper limit of normal (ULN) and/or
    Alanine aminotransferase (ALT) >3 x ULN
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome variable is the absolute change in HbA1c from baseline to week 24 of the double-blind treatment period.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 EEA110
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 650
    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 Decision2008-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-03-14
    The status of studies in GB is no longer updated from 1.1.2021
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