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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   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:2008-001921-33
    Sponsor's Protocol Code Number:MB102-029
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-30
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-001921-33
    A.3Full title of the trial
    A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2
    Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and
    Pharmacodynamics of Dapagliflozin in Subjects with Type 2 Diabetes Mellitus and
    Moderate Renal Impairment Who Have Inadequate Glycemic Control.

    Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date 10-Apr-2008). And Pharmacogenetics Blood Sample Amendment 01 - Site specific (Version 2.0, Date 10-Mar-2008).
    A.4.1Sponsor's protocol code numberMB102-029
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 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 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.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
    DIABETES,NOS
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    To compare the change from baseline in A1C achieved with each dapagliflozin treatment group versus placebo, after 24 weeks of oral administration of double-blind treatment.
    E.2.2Secondary objectives of the trial
    • To compare the change from baseline in estimated GFR in each dapagliflozin
    treatment group versus placebo, after 52 weeks of oral administration of study
    treatment
    • To compare the change from baseline in estimated creatinine clearance (CrCl) in each dapagliflozin treatment group versus placebo, after 52 weeks of oral administration of study treatment
    • To compare the change from baseline in FPG achieved with each dapagliflozin
    treatment group versus placebo, after 24 weeks of oral administration of double-blind treatment
    • To compare the change from baseline in body weight achieved with each
    dapagliflozin treatment group versus placebo, after 24 weeks of oral administration of double-blind treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subjects must be willing and able to give signed and dated written informed consent.
    2) Subjects must have type 2 diabetes with inadequate glycemic control, defined as
    central laboratory A1C ≥ 7.0% and ≤ 11.0%.
    Note: A one-time central laboratory re-test of the A1C is allowed in subjects with an
    initial central enrollment A1C of 6.9% as determined by the Investigator. In situations
    where the central laboratory A1C value meets criteria for re-test, such a re-test of the A1C value is allowed provided the subject is otherwise fully eligible, as determined by the Investigator.
    3) Subjects on a stable anti-diabetic regimen. A stable anti-diabetic regimen is defined as either diet and exercise therapy alone or in combination with a regimen of any approved anti-diabetic medication(s), including insulin, in which either the doses of oral anti-diabetic medications, exenatide, or pramlintide have not changed during the 6 weeks prior to enrollment; or the doses of long-acting insulin or intermediate-acting insulin have not varied by more than 20% during the 6 weeks prior to enrollment.
    4) Subjects with moderate renal impairment. The degree of renal impairment is defined by the estimated GFR, according to the re-expressed abbreviated (four-variable) MDRD Study equation (see Protocol Section 4.1). Moderate renal impairment is defined as an eGFR 30 mL/min/1.73m2 to 59 mL/min/1.73m2.
    5) BMI ≤ 45.0 kg/m2 at the enrollment visit.
    6) Men and women, ≥ 18 years of age at the time of the enrollment visit.
    Women of childbearing potential (WOCBP) must be using an adequate method of
    contraception to avoid pregnancy throughout the study in such a manner that the
    risk of pregnancy is minimized.
    E.4Principal exclusion criteria
    1)WOCBP unwilling or unable to use acceptable method to avoid pregnancy for entire study period
    2)Pregnant or breastfeeding Women
    3)Women with a positive pregnancy test on enrollment or prior to investigational
    product administration
    4)Aspartate Aminotransferase >3X ULN
    5)Alanine Aminotransferase >3X ULN
    6)Total Bilirubin >2 mg/dL (34.2 μmol/L)
    7)Serum Potassium >5.5 meq/L
    8)Serum Phosphorus ≥6.5 mg/dL
    Note: one-time retest may be allowed, as determined by the Investigator, after a
    minimum of 2 weeks following the initiation or adjustment of phosphate binder
    medication. Such cases should be discussed with the Sponsor prior to re-testing the
    serum phosphorus
    9)Serum Calcium <8 mg/dL or >ULN
    10)Positive for hepatitis B surface antigen
    11)Positive for anti-hepatitis C virus antibody
    12)Hemoglobin ≤9.0 g/dL (90 g/L) for men; hemoglobin ≤8.0 g/dL (80 g/L) for women
    13)Creatine Kinase >3X ULN
    14)Abnormal free T4 values. Abnormal TSH value at enrollment will be further evaluated by free T4. Subjects with abnormal free T4 values will be excluded
    15)History of diabetes insipidus
    16)Symptoms of poorly controlled diabetes that would preclude participation in this trial including but not limited to marked polyuria & polydipsia with greater than 10%
    weight loss during the 3 months prior to enrollment, or other signs & symptoms
    17)History of diabetic ketoacidosis or hyperosmolar nonketotic coma
    18)Severe uncontrolled hypertension defined as systolic blood pressure
    ≥180 mmHg &/or diastolic blood pressure ≥ 110 mmHg
    19)Myocardial infarction
    20)Cardiac surgery or revascularization
    21)Unstable angina
    22)Unstable congestive heart failure
    23)CHF New York Heart Association Class III or IV (See Protocol Appendix 3)
    24)Transient ischemic attack or significant cerebrovascular disease
    25)Unstable or previously undiagnosed arrhythmia
    26)History of rapidly progressing renal disease
    27)History of lupus nephritis
    28)History of renal or systemic vasculitis
    29)History of familial renal glucosuria
    30)History of renal artery stenosis, with renovascular hypertension or ischemic
    nephropathy
    31)History of renal transplant
    32)Hemodialysis, ultrafiltration therapy, or peritoneal dialysis within 6 months prior to enrollment
    33)Significant hepatic disease, including, but not limited to, chronic active hepatitis
    1/or severe hepatic insufficiency
    34)Documented history of hepatotoxicity with any medication
    35)Documented history of severe hepatobiliary disease
    36)History of hemoglobinopathy with the exception of sickle cell trait or
    thalassemia minor; or chronic or recurrent hemolysis
    37)Donation of blood or blood products to a blood bank, blood transfusion, or
    participation in a clinical study requiring withdrawal of >400 mL of blood during
    6 weeks prior to enrollment visit
    38)Malignancy within 5 years of enrollment visit (with exception of treated basal cell or treated squamous cell carcinoma)
    39)Known immunocompromised status, including but not limited to, individuals who
    have undergone organ transplantation or who are positive for HIV
    40)Allergies or contraindication to the contents of dapagliflozin tablets
    41)Administration of metformin within 6 weeks of enrollment
    42)Replacement or chronic systemic corticosteroid, defined as any dose of systemic
    corticosteroid taken for >4 weeks within 3 months prior to enrollment visit
    43)History of bariatric surgery or lap-band procedure
    44)Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine,
    diethylpropion, methamphetamine, and/or phendimetrazine, within 30 days of
    enrollment visit
    45)Any unstable endocrine, psychiatric, or rheumatic disorders as judged by the
    Investigator
    46)Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the interpretation of efficacy or safety data
    47)Subject who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data
    48)Subject with any condition which, in the judgment of the Investigator, may render the subject unable to complete the study or which may pose a significant risk to the subject
    49)Subject is currently abusing alcohol or other drugs or has done so within last
    6 months
    50)Subject is a participating Investigator, Study Coordinator, employee of an
    Investigator or immediate family member of any of the aforementioned
    51)Previous participation in a clinical trial with dapagliflozin (BMS-512148) &/or with any other SGLT2 inhibitors
    52)Administration of any other investigational drug within 30 days of planned
    enrollment to this study
    53)Prisoners or subjects who are involuntarily incarcerated
    54)Subjects who are compulsorily detained for treatment of either a psychiatric or
    physical (e.g., infectious disease) illness
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in A1C from baseline to Week 24, or the last
    post-baseline measurement prior to Week 24 if no Week 24 assessment is available
    (LOCF). For rescued subjects, measurements obtained after rescue will not be considered in calculating the primary endpoint.

    The secondary endpoints include the change from baseline in FPG and body weight at Week 24 (LOCF), change from baseline in GFR at Week 52, and change from baseline in CrCl at Week 52.
    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 No
    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 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) 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) 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    LPLV
    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 months1
    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 months1
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 504
    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 Decision2008-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-01
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