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    The EU Clinical Trials Register currently displays   35542   clinical trials with a EudraCT protocol, of which   5841   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-013881-25
    Sponsor's Protocol Code Number:1941-CL-0005
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-02
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2009-013881-25
    A.3Full title of the trial
    Phase IIb, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12-Week Treatment with ASP1941 in Combination with Metformin in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
    A.3.2Name or abbreviated title of the trial where available
    The BALANCE Study
    A.4.1Sponsor's protocol code number1941-CL-0005
    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 SponsorAstellas Pharma Europe B.V.
    B.1.3.4CountryNetherlands
    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 nameASP1941
    D.3.2Product code ASP1941
    D.3.4Pharmaceutical form 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.3.9.1CAS number 951382-34-6
    D.3.9.2Current sponsor codeASP1941
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12,5
    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 nameASP1941
    D.3.2Product code ASP1941
    D.3.4Pharmaceutical form 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.3.9.1CAS number 951382-34-6
    D.3.9.2Current sponsor codeASP1941
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboCoated 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 placeboCoated 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 12.1
    E.1.2Level HLGT
    E.1.2Classification code 10018424
    E.1.2Term Glucose metabolism disorders (incl 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 evaluate the efficacy of a 12-week treatment of 4 doses of ASP1941
    in combination with metformin compared to placebo in combination
    with metformin in subjects with Type 2 Diabetes Mellitus (T2DM) who
    have inadequate glycemic control on metformin alone.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability, pharmacodynamics (PD) and
    pharmacokinetics (PK) of 4 doses of ASP1941 in combination with
    metformin compared to placebo in combination with metformin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · Subject is male or female of ³ 18 years of age at Visit 1.
    · Subject has been diagnosed with T2DM for at least 6 months.
    · Subject has inadequate glycemic control indicated by an HbA1c level
    between 7.0% and 9.5% at start of the placebo run-in period at
    Visit 1 AND does not meet any of the FPG discontinuation criteria.
    · Subject has been on a stable dose of at least 1500 mg/day metformin
    monotherapy for at least 6 weeks prior to Visit 1.
    · Subject is on a stable diet and exercise program (for at least 6 weeks
    prior to Visit 1) and is willing to remain on this program for the
    duration of the study.
    · Subject has a body mass index (BMI) 20 – 45 kg/m2 at Visit 1.
    · Female subject of childbearing potential has a negative serum
    pregnancy test (human chorionic gonadotropin [hCG]) at Visit 1 and
    agrees to use an acceptable form of contraception throughout the
    duration of the study OR is at least 1 year post-menopausal (defined
    as amenorrhea for at least 1 year) or surgically sterile. Acceptable
    methods of contraception are: oral or injectable hormonal
    contraceptives, contraceptive patch, intra-uterine devices, vaginal
    hormonal rings, or sterilization by surgery and only in combination
    with a male condom, a vaginal diaphragm or cervical caps. Male
    study subjects should be advised to use a male condom in addition to
    having their partner use another acceptable method during the study
    and for 3 months after the last dose.
    E.4Principal exclusion criteria
    · Subject has any known complication of T2DM indicating a late
    disease state that in the investigator’s opinion should preclude the
    subject from participation.
    · Subject has type 1 diabetes mellitus.
    · Subject is in need of insulin therapy or has received insulin within
    3 months prior to Visit 1, with the exception of acute use of <7 days.
    · Subject has a serum creatinine higher than upper limit of normal
    range at Visit 1.
    · Subject has an alanine aminotransferase (ALT) and/or aspartate
    aminotransferase (AST) higher than 3 times upper limit of normal
    range or has a total bilirubin more than 2 times upper limit of normal
    at Visit 1.
    · Subject has a urinary microalbumin/creatinine ratio above or equal to
    300 mg/g at Visit 1.
    · Subject has a symptomatic urinary tract infection (UTI) or
    symptomatic genital infection at Visit 1 or during the placebo run-in
    period, including just prior to randomization at Visit 2.
    · Subject has persistent, uncontrolled severe hypertension as indicated
    by a systolic blood pressure >180 mmHg or a diastolic blood
    pressure of >110 mmHg taken in a sitting position after 5 minutes of
    rest on at least 2 measurements (within 30 minutes of each other) at
    Visit 1.
    · Subject has a significant cardiovascular disease, such as myocardial
    infarction or a vascular intervention (e.g. angioplasty or stent) within
    3 months prior to Visit 1, or history of heart failure (New York Heart
    Association [NYHA] Class III-IV).
    · Subject is known to have hepatitis or be a carrier of hepatitis B
    surface antigen (HBsAg), hepatitis C virus (HCV) antibody (enzyme
    linked immunosorbent assay [ELISA] plus confirmatory test), or is
    known positive for human immunodeficiency virus (HIV) HIV-1 and/or HIV-2.
    · Subject is currently receiving an excluded medication (loop-diuretics
    or systemic corticosteroids) or has received any other oral antidiabetic
    drug except for metformin within 3 months prior to Visit 1.
    · Subject has history of lactic acidosis.
    · Subject has a history of drug or alcohol abuse/dependency within
    12 months prior to Visit 1 as defined in the Diagnostic and Statistical
    Manual-IV (DSM-IV).
    · Subject has had a malignancy in the last 5 years, except for
    adequately treated basal or squamous cell carcinoma of the skin or
    carcinoma in situ of the cervix.
    · Female subject who is pregnant, lactating or pre-menopausal with
    positive serum pregnancy test (hCG) at Visit 1 or has an intention of
    becoming pregnant.
    · Subject has an unstable medical or psychiatric illness.
    · Subject has known or suspected hypersensitivity to ASP1941 or any
    components of the formulations used.
    · Subject has previously received ASP1941.
    · Subject is concurrently participating in another drug study or has
    received an investigational drug within 30 days (or the limit set by
    national law, whichever is longer) prior to Visit 1.
    · Subject has any concurrent illness which, in the opinion of the
    investigator, may interfere with treatment or evaluation of safety or
    completion of this study.
    · In the investigator’s judgment, the subject is unable to adhere to the
    treatment regimen, protocol procedures or study requirements.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in HbA1c at 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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    QOL
    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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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.1.3Elderly (>=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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 530
    F.4.2.2In the whole clinical trial 630
    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 Decision2010-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-04-01
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