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    Summary
    EudraCT Number:2008-004913-93
    Sponsor's Protocol Code Number:D1690C00012
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-21
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2008-004913-93
    A.3Full title of the trial
    A 24-week, Multi-centre, International, Double-blind, Randomized, Parallel-group, Placebo-controlled, Phase III Study with a 78-week Extension Period to Evaluate the Effect of Dapagliflozin in Combination with Metformin on Body Weight in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Alone
    A.3.2Name or abbreviated title of the trial where available
    DAPA 12
    A.4.1Sponsor's protocol code numberD1690C00012
    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 nameDapagliflozin
    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 INNDapagliflozin
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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 10012613
    E.1.2Term Diabetes mellitus non-insulin-dependent
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment.
    E.2.2Secondary objectives of the trial
    To assess effect on:
    - Waist circumference
    - Total Body Fat Mass measured by Dual Energy X-ray Absorptiometry
    - Additional weight and glycaemic variables
    - Lean tissue mass as measured by Dual Energy X-ray Absorptiometry
    - Blood pressure
    - Adipose tissue markers
    - Patient reported outcomes
    To assess, in a sub-population, the effect on:
    - Visceral adipose tissue mass
    - Hepatic lipid content

    -To evaluate the safety and tolerability by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycaemic events, calculated creatinine clearance and physical examination findings (eg, oedema) after 24 weeks and 102 weeks

    To assess the same objectives as for the 24-week treatment after 102 weeks
    To assess after 50 and 102 weeks the effect on:
    - Bone Mineral Density
    - Biochemical markers of bone formation and bone resorption
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The MR sub study is a part of main study and therefore there is no special title, date and version for this sub study. The objectives related to this MR substudy are:
    To assess, in a sub-population, the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on energy depots after 24 and 102 weeks of double-blind treatment on:
    - visceral adipose tissue mass
    - hepatic lipid content
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures
    2. Females aged ≥55 and ≤75 years who are post menopausal (or have had hysterectomy) for a period of at least 5 years at time of consenting or males aged ≥30 and ≤75 years at time of consenting
    3. Diagnosed with type 2 diabetes
    4. HbA1c ≥6.5% and ≤8.5%
    5. Body mass index (BMI) ≥25 kg/m2
    6. Body weight ≤120 kg (due to limitations imposed by DXA equipment)
    7. Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment
    before lead-in period:
    8. HbA1c ≥6.5% and ≤8.5%
    9. FPG ≤13.2 mmol/L (≤240 mg/dL)
    at randomization:
    10. HbA1c ≥6.5% and ≤8.5%
    11. FPG ≤13.2 mmol/L (≤240 mg/dL)
    12. Body mass index (BMI) ≥25 kg/m2
    E.4Principal exclusion criteria
    1. Known hypersensitivity to dapagliflozin or metformin. Intolerance to metformin
    2. Type 1 diabetes, diabetes insipidus, corticosteroid-induced type 2 diabetes, history of diabetic ketoacidosis or hypersmolar non-ketonic coma or known condition of congenital renal glucosuria
    3. Symptoms of poorly controlled diabetes that would preclude participation in this trial
    4. Any ongoing oral anti-diabetic treatment apart from metformin or treatment with chronic insulin, within 24 weeks prior to Visit 1 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
    5. Administration of treatment known to significantly influence bone metabolism, including, but not limited to bisphosphonate, calcitonin, replacement or chronic systemic treatment with corticosteroids, hormone replacement therapy (HRT) within 6 months prior to enrolment
    6. Treatment for Human immunodeficiency virus (HIV)/use of antiviral drugs and/or known immunocompromised status, including subjects who have undergone organ transplantation
    7. Body weight change >5% within 3 months prior to enrolment
    8. Severe uncontrolled hypertension defined as systolic BP ≥180 mmHg and/or diastolic BP ≥110 mmHg
    9. Subjects who, in the judgment of the investigator, may be at risk for dehydration
    10. T-score <-2.0 for BMD at lumbar spine, femoral neck, or total hip at baseline DXA measurement. The Medical DXA Core Lab will inform the recruiting investigator whether the subject is eligible or not for randomization based on this criterion.
    11. Vitamin D deficiency (25-hydroxyvitamin D level <12 ng per millilitre (30 nmol per liter)
    12. AST >3 x ULN, ALT >3 x ULN or serum total bilirubin (TB) >34.2 μmol/L (2 mg/dL)
    13. Creatine kinase (CK) >3 x ULN
    14. Haemoglobin ≤105 g/L (≤10.5 g/dL) for men; haemoglobin ≤95 g/L (≤9.5 g/dL) for women
    15. Urine albumin: creatinine ratio (UACR) >1800 mg/g (>203.4 mg/mmol)
    16. Renal failure or renal dysfunction (Creatinine-Clearance using Cockroft Gault formula <60 ml/min) or serum creatinine ≥133 mmol/L (1.5 mg/dL) for male subjects and ≥124 mmol/L (1.4 mg/dL) for female subjects
    17. Thyroid-stimulating hormone (TSH) values outside normal range, to be further confirmed by abnormal free T4 values. Subjects with abnormal free T4 values will be excluded
    18. Significant cardiovascular history within the past 6 months prior to the enrolment visit (myocardial infarction, unstable angina, transient ischemic attack (TIA), unstable or previously undiagnosed arrhythmia, unstable chronic heart failure, cardiac surgery or revascularization (CABG/PTCA))
    19. History of bariatric surgery
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome variable:
    1. Change in body weight from baseline to week 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 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) 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 182
    F.4.2.2In the whole clinical trial 182
    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 Decision2009-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-01
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