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    Summary
    EudraCT Number:2009-010224-25
    Sponsor's Protocol Code Number:CV181-080
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-22
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-010224-25
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, PO, BID, in Combination with Metformin in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin, Alone.
    A.4.1Sponsor's protocol code numberCV181-080
    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.1.3.4CountryUnited States
    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 nameSaxagliptin
    D.3.2Product code BMS-477118-11
    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 INNSaxagliptin
    D.3.9.1CAS number 361442-04-8
    D.3.9.2Current sponsor codeBMS-477118-11
    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.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 10063624
    E.1.2Term Type II diabetes mellitus inadequate control
    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 endpoint is the change in A1C from baseline to Week 12 (or the last post
    baseline measurement prior to Week 12, if no Week 12 assessment is available). The
    primary comparison is between the saxagliptin 2.5 mg BID (plus stable background
    metformin IR) and placebo (plus stable background metformin IR) treatment groups.
    E.2.2Secondary objectives of the trial
    Comparison of saxagliptin 2.5 mg or placebo in combination with metformin IR
    following 12 weeks of double-blind therapy for the following secondary objectives:
    1. The mean change from baseline in FPG.
    2. The proportion of subjects who will achieve a therapeutic glycemic response
    defined as A1C < 7.0%.
    3. The proportion of subjects who will achieve a therapeutic glycemic response
    defined as A1C ≤ 6.5%
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed Written Informed Consent
    1) Subjects must be willing and able to give written informed consent.
    2) Subjects with a diagnosis of type 2 diabetes mellitus.
    3) Subjects must be on a stable, BID dosing of at least 1500 mg of metformin IR for ≥ 8 weeks prior to enrollment.
    4) Subjects must have a A1C ≥ 7.0% and ≤ 10.0% at screening to be randomized.
    5) Subjects must have a fasting C-peptide ≥ 0.8 ng/mL (0.34 nmol/L) at screening.
    6) Subjects must have a body mass index ≤ 45.0 kg/m2.
    7) Men and women, ages 18 to 78 (inclusive).
    WOCBP must be using an adequate method of contraception to avoid pregnancy
    throughout the study, and up to 4 weeks after last study drug was taken in such a
    manner that the risk of pregnancy is minimized.
    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. Post menopause is defined as:
    • Amenorrhea ≥ 12 consecutive months without another cause or,
    • For women with irregular menstrual periods and on hormone replacement therapy
    (HRT), a documented serum follicle stimulating hormone (FSH) level
    ≥ 35 mIU/mL.
    E.4Principal exclusion criteria
    1) WOCBP who are unwilling or unable to use an
    acceptable method to avoid pregnancy for the entire study period and up to 4 weeks
    after the final dose of study drug.
    2) Women who are pregnant or breastfeeding.
    3) Women with a positive urine HCG pregnancy test at randomization or prior to
    investigational product administration.
    4) Sexually active fertile men not using effective birth control for the entire study period and up to 4 weeks after last study drug was taken if their partners are WOCBP.
    5) Symptoms of poorly controlled T2DM including, but not limited to marked polyuria
    and polydipsia, with a greater than 10% weight loss during the 3 months prior to
    screening or other signs and symptoms
    6) History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
    7) Insulin therapy within 1 year of screening (with the exception of insulin therapy
    during a hospitalization or use in pregnant women with gestational diabetes).
    8) Significant cardiovascular history defined as:
    a) History of myocardial infarction, coronary artery or bypass graft(s), valvular
    disease or repair, unstable angina pectoris, transient ischemic attack, or cerebral
    vascular event within 3 months prior to entry into the study or,
    b) Congestive heart failure defined as New York Heart Association (NYHA) stage
    III or IV and / or known left ventricular ejection fraction ≤ 40%
    9) History of hemoglobinopathies
    10) Chronic or repeated intermittent corticosteroid treatment.
    11) History of unstable or rapidly progressive renal disease.
    12) History of alcohol or drug abuse within 1 year prior to enrollment.
    13) Unstable psychiatric disorders.
    14) Administration of any other study drug or participation in a clinical research trial
    within 30 days of planned enrollment to this study (or a longer period if dictated by
    local regulatory authorities).
    15) Any condition, which in the Investigator’s opinion, may render the subject unable to complete the study or may pose significant risk to the subject.
    16) Subjects on a commercial weight loss program with ongoing weight loss, or on an
    intensive exercise program.
    17) FPG > 270 mg/dL prior to randomization.
    18) Active liver disease and/or significant abnormal liver function (defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 x ULN and/or serum total bilirubin > 2.0 mg/dL).
    19) History of positive serologic evidence of current infectious liver disease including
    anti-HAV (IgM), HbsAg, or anti-HCV. Subjects who may have isolated positive anti
    HBs may be included.
    20) Serum creatinine (Scr) > 1.5 mg/dL (132.6 mmol/L) for males and ≥ 1.4 mg/dL (123.8 mmol/L) for females, or calculated creatinine clearance (by Cockcroft-Gault equation) below 60 mL/min
    21) Anemia of any etiology defined as hemoglobin ≤ 12.0 g/dL (120 g/L) for men and ≤ 11.0 g/dL (110 g/L) for women.
    22) Creatinine kinase (CK ) ≥ 3X ULN.
    23) Subjects that have an abnormal TSH value at screening will be further evaluated by free T4. Subjects with an abnormal T4 will be excluded.
    24) Clinically significant (CS) abnormalities in any pre-randomization laboratory
    analyses or ECG that, in the Investigator’s opinion, would preclude randomization.
    25) Subjects who have contraindications to therapy as outlined in the Saxagliptin
    Investigator Brochure or local metformin IR package insert.
    26) Subjects with known contraindications to DPP-IV therapy.
    27) Treatment with potent systemic cytochrome P450 3A4 (CYP3A4) inducers
    28) History of administration of any antihyperglycemic therapy (other than metformin IR as applicable) for more than 3 consecutive days or 7 non-consecutive days during the 8 weeks prior to screening.
    29) Use of any other antihyperglycemic medication (other than metformin IR as
    applicable) after entry into the lead-in period (with the exception of insulin therapy
    during a hospitalization for other causes).
    30) Prior treatment with saxagliptin.
    31) Use of any prescription weight loss medication within 8 weeks prior to screening.
    32) Any history of, or plans for during the course of the clinical trial, weight loss surgery
    33) Subjects taking prohibited medication.
    34) Prisoners or subjects who are involuntarily incarcerated.
    35) Subjects who are compulsorily detained for treatment of either a psychiatric or
    physical illness.
    36) Subjects that do not demonstrate good compliance during the lead-in period with
    study drug and metformin IR (≥ 80% and ≤ 120%, each)
    37) History of malignancy (except subjects who have been disease-free for > 5 years), except if the malignancy was a basal or squamous cell skin carcinoma. Women with a history of cervical dysplasia (CIN2 or higher) should be excluded unless 2 consecutive normal cervical smears have subsequently been recorded prior to enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    Change in A1C level from baseline to Week 12, (or the last post baseline measurement prior to Week 12, if no Week 12 assessment is available)
    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.8.3 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 Information not present in EudraCT
    E.8.5.1Number of sites anticipated in the EEA16
    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 years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-05-22. Yes
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 152
    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)
    Please refer to protocol section 4.1
    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 Decision2009-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-02-24
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