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    Summary
    EudraCT Number:2010-019797-32
    Sponsor's Protocol Code Number:MB102-073
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-01
    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 ConcernedFinland - Fimea
    A.2EudraCT number2010-019797-32
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate
    the Safety and Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with inadequately controlled
    hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker
    (ARB)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Patients with Type 2 Diabetes with not very well controlled high blood pressure taking medicine called Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB). The Phase 3 Trial is carried out at several sites and neither patients nor doctors know to which study treatment (medication in different strength or dummy treatment) they are randomly assigned.

    A.4.1Sponsor's protocol code numberMB102-073
    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 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 supportBristol Myers Squibb International Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol Myers Squibb International Corporation
    B.5.2Functional name of contact pointSylvie Simon
    B.5.3 Address:
    B.5.3.1Street AddressAvenue de Finlande 8
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32 2 352 7105
    B.5.5Fax number+32 2 352 7164
    B.5.6E-maileu-su@bms.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.3.9.3Other descriptive nameDapagliflozin 10 mg
    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) 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
    Men and women with type 2 diabetes, ages ≥ 18 to ≤ 89 years, who have type 2
    diabetes with inadequately controlled hypertension.
    E.1.1.1Medical condition in easily understood language
    Men and women with type 2 diabetes, between 18 and 89 years old, who have type 2 diabetes with not very well controlled high blood pressure
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10066860
    E.1.2Term Uncontrolled hypertension
    E.1.2System Organ Class 100000004866
    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 seated systolic blood pressure after 12 weeks of double-blind treatment between the dapagliflozin 10 mg treatment group and the placebo treatment group.
    • To compare the change from baseline in HbA1c after 12 weeks of double-blind treatment between the dapagliflozin 10 mg treatment group and the placebo treatment group.
    E.2.2Secondary objectives of the trial
    To compare the change from baseline in 24 hour ambulatory systolic blood pressure after 12 weeks of doubleblind treatment between the dapagliflozin 10 mg treatment group and the placebo treatment group.
    • To compare the change from baseline in seated and 24 hour ambulatory diastolic blood pressure after 12 weeks
    of double-blind treatment between the dapagliflozin 10 mg treatment group and the placebo treatment group.
    • To compare the change from baseline in serum uric acid after 12 weeks of double-blind treatment between the dapagliflozin 10 mg treatment group and the placebo treatment group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects must have type 2 diabetes with inadequate glycemic control, defined as central laboratory HbA1c ≥ 7.0% and ≤ 10.5% obtained at the enrollment visit.
    • Subjects must be on a stable dose of an OAD for at least 6 weeks (12 weeks for a TZD) or a stable daily dose of insulin, as a monotherapy or in combination with another OAD, for 8 weeks prior to enrollment and a stable effective therapeutic dose of an ACEI or an ARB for at least 4 weeks. Stable dose is defined as a dose that has remained the same for the specified number of weeks, as mentioned above, prior to the enrollment visit.
    • Subjects must have inadequately controlled hypertension, defined as seated SBP ≥ 140 and < 165 mmHg AND seated DBP ≥ 85 and < 105 mmHg, each representingthe mean of three consecutive determinations, evaluated at both the enrollment and Day 1 visits.
    • Subjects must have a mean 24-hour blood pressure ≥ 130/80 mmHg as determined by ambulatory blood pressure monitoring (ABPM) during lead in, measured between Day-7 and Day-1, within 1 week prior to the Day 1 randomization visit.
    • C-peptide ≥ 0.8 ng/mL (0.30 nmol/L)
    • BMI ≤ 45.0 kg/m2 at the enrollment visit.
    • Men and women ages must be ≥ 18 and ≤ 89 years old at the time of the enrollment visit. Men and women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
    • WOCBP 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 investigational product.
    • Women must not be breastfeeding.
    E.4Principal exclusion criteria
    1) History of diabetes insipidus.
    2) Symptoms of poorly controlled diabetes that 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 enrollment, or other signs and symptoms.
    3) History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
    4) History of malignant or accelerated hypertension.
    5) Known or suspected secondary hypertension.
    Any of the following CV/Vascular Diseases within 6 months of the enrollment visit:
    6) Myocardial infarction.
    7) Cardiac surgery or revascularization (coronary artery bypass surgery [CABG]/
    percutaneous transluminal coronary angioplasty [PTCA]).
    8) Unstable angina.
    9) Unstable congestive heart failure (CHF).
    10) CHF New York Heart Association (NYHA) Class III or IV. (see Appendix 1)
    11) Transient ischemic attack (TIA) or significant cerebrovascular disease.
    12) Unstable or previously undiagnosed arrhythmia.
    Metabolic Diseases
    13) Under revised protocol #4 subjects with a History of Gout may be entered into the study.
    14) History of unstable or rapidly progressing renal disease.
    15) Conditions of congenital renal glucosuria.
    16) Renal allograft
    17) Significant hepatic disease, including but not limited to, chronic active hepatitis and/or severe hepatic insufficiency
    18) Documented history of hepatotoxicity with any medication.
    19) Documented history of severe hepatobiliary disease
    20) History of hemoglobinopathy, with the exception of sickle cell trait (SA) or thalassemia minor; or chronic or recurrent hemolysis.
    21) 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 the 6 weeks prior to the enrollment visit.
    22) Malignancy within 5 years of the enrollment visit (with the exception of treated basal cell or treated
    squamous cell carcinoma of the skin).
    23) Known immunocompromised status, including but not limited to, individuals who
    have undergone organ transplantation or who are positive for the human immunodeficiency virus.
    Central Laboratory Test Findings at Enrollment
    24) Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN).
    25) Alanine aminotransferase (ALT) > 3X ULN.
    26) Serum total bilirubin (TB) ≥ 1.5X ULN
    27) Serum Creatinine (SCr) ≥ 2.0 mg/dL unless subject is on metformin then the exclusionary limits will be SCr ≥ 1.50 mg/dL (133 μmol/L) for male subjects; SCr ≥ 1.40 mg/dL (124 μmol/L) for female subjects
    28) Estimated creatinine clearance (Crcl) of < 60ml/min
    29) Hemoglobin ≤ 10.0 g/dL (100 g/L) for men; hemoglobin ≤ 9.0 g/dL (90 g/L) for women.
    30) Creatine kinase (CK) > 3X ULN.
    31) Positive for hepatitis B surface antigen.
    32) Positive for anti-hepatitis C virus antibody.
    33) Abnormal free T4 value.
    34) Allergies or contraindication to the contents of dapagliflozin tablets.
    35) Obesity that would limit accurate blood pressure measurement
    36) History of bariatric surgery or lap-band procedure.
    37) Administration of sibutramine, phentermine, rimonabant, benzphetamine, diethylpropion, methamphetamine,
    orlistat, and/or phendimetrazine.
    38) Prisoners or subjects who are involuntarily incarcerated.
    39) Subjects who are compulsorily detained for treatment of either a psychiatric or
    physical (eg, infectious disease) illness.
    40) Replacement or chronic systemic corticosteroid therapy, defined as any dose of
    systemic corticosteroid taken for > 4 weeks within 3 months prior to enrollment visit.
    NOTE: Topical or inhaled corticosteroids are allowed.
    41) Any unstable endocrine, psychiatric, rheumatic disorders as judged by the Investigator.
    42) 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.
    43) 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
    44) Subject is currently abusing alcohol or other drugs or has done so within the last 6 months.
    45) Subject is a participating investigator, study coordinator, employee of an investigator or immediate family member of any of the aforementioned
    46) Previous participation in a clinical trial with dapagliflozin (BMS-512148) and/or with any other SGLT2 inhibitors.
    47) Administration of any other investigational drug within 30 days of planned enrollment to this study
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary endpoints are the change in seated systolic blood pressure and the change in HbA1c from baseline at Week 12, or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available. For subjects rescued for hypertension, measurements obtained after initiation of rescue medication will not be considered in calculating the co-primary endpoint of seated systolic blood pressure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    The secondary endpoints include the change in 24 hour ambulatory systolic blood pressure from baseline at Week 12, or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available, the change in seated and 24 hour ambulatory diastolic blood pressure from baseline at Week 12, or the last post-baseline measurement
    prior to Week 12, if no Week 12 assessment is available and the change in serum uric acid from baseline at Week 12, or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available. For subjects rescued for hypertension, measurements obtained after initiation of rescue medication will not be considered in calculating the secondary endpoints of 24 hour ambulatory systolic blood pressure and seated and 24 hour ambulatory diastolic blood pressure.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12
    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 No
    E.6.7Pharmacodynamic No
    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 trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA101
    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
    Colombia
    Czech Republic
    Denmark
    Finland
    Germany
    Hungary
    India
    Ireland
    Mexico
    Peru
    Poland
    Puerto Rico
    Russian Federation
    Spain
    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
    last patient last visit
    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 months10
    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 months10
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 401
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 133
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 145
    F.4.2.2In the whole clinical trial 534
    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)
    After completion of the trial patients receive standard 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 Decision2011-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-15
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